{"id":"trometamol","rwe":[{"pmid":"41817910","year":"2026","title":"Analysis of the efficacy of fosfomycin trometamol in preventing biofilm bacterial infection in double-J stents among diabetic patients and the factors associated with infection.","finding":"","journal":"International urology and nephrology","studyType":"Clinical Study"},{"pmid":"41782795","year":"2026","title":"From Needle to Sachet: Fosfomycin Versus Amikacin for Cystoscopy Prophylaxis.","finding":"","journal":"Cureus","studyType":"Clinical Study"},{"pmid":"41718138","year":"2026","title":"Ciprofloxacin Versus Fosfomycin for Empirical Prophylaxis Before Transrectal Prostate Biopsy: Clinical, Microbiological, and Patient-Reported Outcomes from a Prospective Study.","finding":"","journal":"Medical sciences (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41714094","year":"2026","title":"A Robust LC-MS/MS Bioanalytical Strategy for Simultaneous Quantification of Tramadol HCl and Dexketoprofen Trometamol and Its Use in Pharmacokinetic Studies.","finding":"","journal":"Biomedical chromatography : BMC","studyType":"Clinical Study"},{"pmid":"41594090","year":"2026","title":"Prevalence of and Factors Associated with Antibiotic Prescription in Gynecological Practices in Germany.","finding":"","journal":"Antibiotics (Basel, Switzerland)","studyType":"Clinical Study"}],"_fda":{"id":"c8c27324-37d9-4f12-abe7-bc3b5fbf9fe7","set_id":"4af52118-c12b-4ad5-30bb-959848357e8a","openfda":{"unii":["023C2WHX2V"],"route":["INTRAVENOUS"],"rxcui":["198412"],"spl_id":["c8c27324-37d9-4f12-abe7-bc3b5fbf9fe7"],"brand_name":["THAM"],"spl_set_id":["4af52118-c12b-4ad5-30bb-959848357e8a"],"package_ndc":["0409-1593-14","0409-1593-04"],"product_ndc":["0409-1593"],"generic_name":["TROMETHAMINE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["TROMETHAMINE"],"manufacturer_name":["Hospira, Inc."],"application_number":["NDA013025"],"is_original_packager":[true]},"version":"20","warnings":["WARNINGS Large doses of Tham Solution may depress ventilation, as a result of increased blood pH and reduced CO 2 concentration. Thus, dosage should be adjusted so that blood pH is not allowed to increase above normal. In situations in which respiratory acidosis may be present concomitantly with metabolic acidosis, the drug may be used with mechanical assistance to ventilation. Care must be exercised to prevent perivascular infiltration since this can cause inflammation, necrosis and sloughing of tissue. Venospasm and intravenous thrombosis, which may occur during infusion, can be minimized by insuring that the injection needle is well within the largest available vein and that solutions are slowly infused. Intravenous catheters are recommended. If perivascular infiltration occurs, institute appropriate countermeasures (see ADVERSE REACTIONS ). Tham Solution (tromethamine injection) should be administered slowly and in amounts sufficient only to correct the existing acidosis, and to avoid overdosage and alkalosis. Overdosage in terms of total drug and/or too rapid administration, may cause hypoglycemia of a prolonged duration (several hours). Therefore, frequent blood glucose determinations should be made during and after therapy. Extreme care should be exercised in patients with renal disease or reduced urinary output because of potential hyperkalemia and the possibility of a decreased excretion of tromethamine. In such patients, the drug should be used cautiously with electrocardiographic monitoring and frequent serum potassium determinations. Because clinical experience has been limited generally to short-term use, the drug should not be administered for more than a period of one day except in a life-threatening situation. The intravenous administration of Tham Solution can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store."],"pregnancy":["Pregnancy: Animal reproduction studies have not been conducted with tromethamine. It is also not known whether tromethamine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tromethamine should be given to a pregnant woman only if clearly needed."],"overdosage":["OVERDOSAGE Too rapid administration and/or excessive amounts of tromethamine may cause alkalosis, hypoglycemia, overhydration or solute overload. In the event of overdosage, discontinue the infusion, evaluate the patient and institute appropriate countermeasures (see WARNINGS , PRECAUTIONS and ADVERSE REACTIONS ). The LD 50 values for the acute intravenous toxicity of THAM are influenced by the rate of infusion of the dose administered. Intravenous LD 50 Mice = 3,500 mg/kg Intravenous LD 50 Rats = 2,300 mg/kg"],"description":["DESCRIPTION Tham Solution (tromethamine injection) is a sterile, non-pyrogenic 0.3 M solution of tromethamine, adjusted to a pH of approximately 8.6 with glacial acetic acid. It is administered by intravenous injection, by addition to ACD blood for priming cardiac bypass equipment and by injection into the ventricular cavity during cardiac arrest. Each 100 mL contains tromethamine 3.6 g (30 mEq) in water for injection. The solution is hypertonic 389 mOsmol/L (calc.). pH 8.6 (8.4-8.7). The solution contains no bacteriostat, antimicrobial agent or added buffer (except acetic acid for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. Tham solution is a parenteral systemic alkalizer and fluid replenisher. Tromethamine, USP (sometimes called “tris” or “tris buffer”) is chemically designated 2-amino-2-(hydroxymethyl)-1, 3-propanediol, a solid readily soluble in water, also classified as an organic amine buffer. It has the following structural formula: Water for Injection, USP is chemically designated H 2 0. structural formula tromethamine"],"precautions":["PRECAUTIONS Blood pH, PCO 2 bicarbonate, glucose and electrolyte determinations should be performed before, during and after administration of Tham Solution. While it has not been shown that the drug increases coagulation time in humans, this possibility should be kept in mind since this has been noted experimentally in dogs. Do not administer unless solution is clear and seal is intact. Discard unused portion. Pregnancy: Animal reproduction studies have not been conducted with tromethamine. It is also not known whether tromethamine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tromethamine should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when THAM Solution is administered to a nursing mother. Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with THAM Solution have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility. Pediatric Use: The safety and effectiveness of THAM Solution in pediatric patients is based on over 30 years’ clinical experience documented in the literature and on safety surveillance. THAM Solution has been used to treat severe cases of metabolic acidosis with concurrent respiratory acidosis because it does not raise PCO 2 as bicarbonate does in neonates and infants with respiratory failure. It has also been used in neonates and infants with hypernatremia and metabolic acidosis to avoid the additional sodium given with the bicarbonate. However, because the osmotic effects of THAM Solution are greater and large continuous doses are required, bicarbonate is preferred to THAM Solution in the treatment of acidotic neonates and infants with RDS. Hypoglycemia may occur when this product is used in premature and even full-term neonates (see WARNINGS and ADVERSE REACTIONS ). Geriatric Use: Clinical studies of Tham solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function."],"how_supplied":["HOW SUPPLIED Tham Solution (tromethamine injection) is available as: Unit of Sale Concentration NDC-0409-1593-04 Case of 6 Single-dose 500 mL large volume glass containers 500 mL (150 mEq) Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing."],"geriatric_use":["Geriatric Use: Clinical studies of Tham solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function."],"pediatric_use":["Pediatric Use: The safety and effectiveness of THAM Solution in pediatric patients is based on over 30 years’ clinical experience documented in the literature and on safety surveillance. THAM Solution has been used to treat severe cases of metabolic acidosis with concurrent respiratory acidosis because it does not raise PCO 2 as bicarbonate does in neonates and infants with respiratory failure. It has also been used in neonates and infants with hypernatremia and metabolic acidosis to avoid the additional sodium given with the bicarbonate. However, because the osmotic effects of THAM Solution are greater and large continuous doses are required, bicarbonate is preferred to THAM Solution in the treatment of acidotic neonates and infants with RDS. Hypoglycemia may occur when this product is used in premature and even full-term neonates (see WARNINGS and ADVERSE REACTIONS )."],"effective_time":"20241213","nursing_mothers":["Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when THAM Solution is administered to a nursing mother."],"adverse_reactions":["ADVERSE REACTIONS Generally, side effects have been infrequent. Respiratory: Although the incidence of ventilatory depression is low, it is important to keep in mind that such depression may occur. Respiratory depression may be more likely to occur in patients who have chronic hypoventilation or those who have been treated with drugs which depress respiration. In patients with associated respiratory acidosis, tromethamine should be administered with mechanical assistance to ventilation. Vascular: Extreme care should be taken to avoid perivascular infiltration. Local tissue damage and subsequent sloughing may occur if extravasation occurs. Chemical phlebitis and venospasm also have been reported. Hematologic: Transient depression of blood glucose may occur. Hepatic: Infusion via low-lying umbilical venous catheters has been associated with hepatocellular necrosis. Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary."],"contraindications":["CONTRAINDICATIONS Tham Solution (tromethamine injection) is contraindicated in uremia and anuria. In neonates it is also contraindicated in chronic respiratory acidosis and salicylate intoxication."],"how_supplied_table":["<table width=\"55%\"><col width=\"50%\"/><col width=\"50%\"/><thead><tr><th align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><content styleCode=\"bold\">Unit of Sale</content></th><th align=\"center\" styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\">Concentration</content></th></tr></thead><tbody><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">NDC-0409-1593-04</content> Case of 6 Single-dose 500 mL large volume glass containers</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><paragraph>500 mL (150 mEq)</paragraph></td></tr></tbody></table>"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY When administered intravenously as a 0.3 M solution, tromethamine act as a proton acceptor and prevents or corrects acidosis by actively binding hydrogen ions (H + ). It binds not only cations of fixed or metabolic acids, but also hydrogen ions of carbonic acid, thus increasing bicarbonate anion (HCO 3 ‾). Tromethamine also acts as an osmotic diuretic, increasing urine flow, urinary pH, and excretion of fixed acids, carbon dioxide and electrolytes. A significant fraction of tromethamine (30% at pH 7.40) is not ionized and therefore is capable of reaching equilibrium in total body water. This portion may penetrate cells and may neutralize acidic ions of the intracellular fluid. The drug is rapidly eliminated by the kidney; 75% or more appears in the urine after eight hours. Urinary excretion continues over a period of three days. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium."],"indications_and_usage":["INDICATIONS AND USAGE Tham Solution (tromethamine injection) is indicated for the prevention and correction of metabolic acidosis. In the following conditions it may help to sustain vital functions and thus provide time for treatment of the primary disease: Metabolic Acidosis Associated with Cardiac Bypass Surgery. Tham Solution has been found to be primarily beneficial in correcting metabolic acidosis which may occur during or immediately following cardiac bypass surgical procedures. Correction of Acidity of ACD Blood in Cardiac Bypass Surgery. It is well known that ACD blood is acidic and becomes more acidic on storage. Tromethamine effectively corrects this acidity. Tham Solution may be added directly to the blood used to prime the pump-oxygenator. When ACD blood is brought to a normal pH range the patient is spared an initial acid load. Additional tromethamine may be indicated during cardiac bypass surgery should metabolic acidosis appear. Metabolic Acidosis Associated with Cardiac Arrest. Acidosis is nearly always one of the consequences of cardiac arrest and, in some instances, may even be a causative factor in arrest. It is important therefore, that the correction of acidosis should be started promptly with other resuscitative efforts. By correcting acidosis, Tham Solution (tromethamine injection) has caused the arrested heart to respond to resuscitative efforts after standard methods alone had failed. In these cases, tromethamine was given intraventricularly. It is to be noted, however, that such precariously ill patients often have died subsequently of causes unrelated to the administration of tromethamine. With administration by the peripheral venous route, metabolic acidosis has been corrected in a majority of patients. The success in reinstitution of cardiac rhythm by this means probably has not been of the same order of magnitude as with the intraventricular route."],"spl_unclassified_section":["For the Prevention and Correction of Severe Metabolic Acidosis Large Volume Glass Container R x only","Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1213-2.0 Revised: 2/2020 Hospira Logo"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Tham Solution (tromethamine injection) is administered by slow intravenous infusion, by addition to pump-oxygenator ACD blood or other priming fluid or by injection into the ventricular cavity during cardiac arrest. For infusion by peripheral vein, a large needle should be used in the largest antecubital vein or an indwelling catheter placed in a large vein of an elevated limb to minimize chemical irritation of the alkaline solution during infusion. Catheters are recommended. Dosage and rate of administration should be carefully supervised to avoid overtreatment (alkalosis). Pretreatment and subsequent determinations of blood values (e.g. pH, PCO 2 , PO 2 , glucose and electrolytes) and urinary output should be made as necessary to monitor dosage and progress of treatment. In general, dosage should be limited to an amount sufficient to increase blood pH to normal limits (7.35 to 7.45) and to correct acid-base derangements. The total quantity to be administered during the period of illness will depend upon the severity and progression of the acidosis. The possibility of some retention of tromethamine, especially in patients with impaired renal function, should be kept in mind. The intravenous dosage of Tham Solution (tromethamine injection) may be estimated from the buffer base deficit of the extracellular fluid in mEq/liter determined by means of the Siggaard-Andersen nomogram. The following formula is intended as a general guide: Tham Solution (mL of 0.3 M) Required = Body Weight (kg) X Base Deficit (mEq/liter) X 1.1* Thus, a 70 kg patient with a buffer base deficit (“negative base excess”) of 5 mEq/liter would require 70 x 5 x 1.1 = 385 mL of Tham Solution containing 13.9 g (115 mEq) of tromethamine. The need for administration of additional Tham Solution is determined by serial determinations of the existing base deficit. * Factor of 1.1 accounts for an approximate reduction of 10% in buffering capacity due to the presence of sufficient acetic acid to lower pH of the 0.3 M solution to approximately 8.6. Correction of Metabolic Acidosis Associated with Cardiac Bypass Surgery: An adverse dose of approximately 9.0 mL/kg (324 mg/kg) has been used in clinical studies with Tham Solution (tromethamine injection). This is equivalent to a total dose of 630 mL (189 mEq) for 70 kg patient. A total single dose of 500 mL (150 mEq) is considered adequate for most adults. Larger single doses (up to 1000 mL) may be required in unusually severe cases. It is recommended that individual doses should not exceed 500 mg/kg (227 mg/lb) over a period of not less than one hour. Thus, for a 70 kg (154 pound) patient the dose should not exceed a maximum of 35 g per hour (1078 mL of a 0.3 M solution). Repeated determinations of pH and other clinical observations should be used as a guide to the need for repeat doses. Correction of Acidity of ACD Blood in Cardiac Bypass Surgery: The pH of stored blood ranges from 6.80 to 6.22 depending upon the duration of storage. The amount of Tham Solution used to correct this acidity ranges from 0.5 to 2.5 g (15 to 77 mL of a 0.3 M solution) added to each 500 mL of ACD blood used for priming the pump-oxygenator. Clinical experience indicates that 2 g (62 mL of a 0.3 M solution) added to 500 mL of ACD blood is usually adequate. Correction of Metabolic Acidosis Associated with Cardiac Arrest: In the treatment of cardiac arrest, Tham Solution should be given at the same time that other standard resuscitative measures, including manual systole, are being applied. If the chest is open, Tham Solution is injected directly into the ventricular cavity. From 2 to 6 g (62 to 185 mL of a 0.3 M solution) should be injected immediately. Do not inject into the cardiac muscle. If the chest is not open, from 3.6 to 10.8 g (111 to 333 mL of a 0.3 M solution) should be injected immediately into a larger peripheral vein. Additional amounts may be required to control acidosis persisting after cardiac arrest is reversed. Correction of Metabolic Acidosis Associated with RDS in Neonates and Infants: The initial dose of Tham Solution should be based on initial pH and birthweight amounting to approximately 1 mL per kg for each pH unit below 7.4. Further doses have been given according to changes in P a O 2 , pH and PCO 2 . Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see CONTRAINDICATIONS )."],"spl_product_data_elements":["THAM TROMETHAMINE TROMETHAMINE TROMETHAMINE WATER ACETIC ACID"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label 500 mL THAM SOLUTION Tromethamine Injection Rx only Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with THAM Solution have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility."]},"tags":[{"label":"trometamol","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"B05BB03","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Topical","category":"route"},{"label":"Cream","category":"form"},{"label":"Injection","category":"form"},{"label":"Active","category":"status"},{"label":"Allergic conjunctivitis","category":"indication"},{"label":"Post-Op Ocular Inflammation","category":"indication"},{"label":"Post-Op Photophobia","category":"indication"},{"label":"Postoperative Ocular Pain","category":"indication"},{"label":"Hospira","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Buffers","category":"pharmacology"},{"label":"Excipients","category":"pharmacology"},{"label":"Pharmaceutic Aids","category":"pharmacology"},{"label":"Pharmaceutical Vehicles","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"commonSideEffects":[{"effect":"Respiratory depression","drugRate":"low","severity":"unknown"},{"effect":"Hepatocellular necrosis","drugRate":"reported","severity":"unknown"},{"effect":"Venous thrombosis or phlebitis","drugRate":"reported","severity":"unknown"},{"effect":"Hypervolemia","drugRate":"reported","severity":"unknown"},{"effect":"Local tissue damage and subsequent sloughing","drugRate":"reported","severity":"unknown"},{"effect":"Chemical phlebitis","drugRate":"reported","severity":"unknown"},{"effect":"Venospasm","drugRate":"reported","severity":"unknown"},{"effect":"Infection at the site of injection","drugRate":"reported","severity":"unknown"},{"effect":"Febrile response","drugRate":"reported","severity":"unknown"}],"contraindications":["Acute gastric ulcer with perforation","Acute nephropathy","Anemia","Anuria","Asthma","Blood coagulation disorder","Breastfeeding (mother)","Cardiovascular event risk","Cerebral hemorrhage","Cerebrovascular accident","Chronic heart failure","Corneal degeneration","Corneal erosion","Coronary artery bypass graft","Decreased respiratory function","Diabetes mellitus","Disease of liver","Disorder of cardiovascular system","Disorder of cornea","Duodenal ulcer disease","Gastric ulcer","Gastrointestinal hemorrhage","Gastrointestinal ulcer","Hemophilia","Hyperkalemia"],"specialPopulations":{"Pregnancy":"Tromethamine should be given to pregnant woman only if clearly needed.","Geriatric use":"In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function.","Paediatric use":"The safety and effectiveness of THAM Solution in pediatric patients is based on over 30 years clinical experience documented in the literature and on safety surveillance.","Hepatic impairment":"decreased hepatic"}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=trometamol","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:51:42.422891+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Trometamol","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:51:50.455905+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:51:48.815746+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=trometamol","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:51:49.327530+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:51:41.165774+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:51:41.165804+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3186668/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:51:50.089847+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA013025","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:51:41.165808+00:00"}},"allNames":"tham","offLabel":[],"synonyms":["tromethamine","trisamin","trisamine","trisaminol","trometamol"],"timeline":[{"date":"1965-12-16","type":"positive","source":"DrugCentral","milestone":"FDA approval (Hospira)"}],"approvals":[{"date":"1965-12-16","orphan":false,"company":"HOSPIRA","regulator":"FDA"}],"brandName":"Tham","ecosystem":[{"indication":"Allergic conjunctivitis","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"alcaftadine","slug":"alcaftadine","company":"Allergan"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":null},{"indication":"Post-Op Ocular Inflammation","otherDrugs":[{"name":"benzalkonium","slug":"benzalkonium","company":""},{"name":"bromfenac","slug":"bromfenac","company":"Bausch And Lomb Inc"},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""}],"globalPrevalence":null},{"indication":"Post-Op Photophobia","otherDrugs":[{"name":"diclofenac","slug":"diclofenac","company":""},{"name":"ketorolac","slug":"ketorolac","company":""}],"globalPrevalence":null},{"indication":"Postoperative Ocular Pain","otherDrugs":[{"name":"bromfenac","slug":"bromfenac","company":"Bausch And Lomb Inc"},{"name":"diclofenac","slug":"diclofenac","company":""},{"name":"difluprednate","slug":"difluprednate","company":"Alcon Pharms Ltd"},{"name":"ketorolac","slug":"ketorolac","company":""}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","drugClass":"trometamol","explanation":"","oneSentence":"","technicalDetail":"Trometamol is a tromethamine salt that acts as a pH buffer, increasing the pH of the ocular surface to alleviate symptoms of allergic conjunctivitis, post-op ocular inflammation, post-op photophobia, and postoperative ocular pain."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Tris","title":"Tris","extract":"Tris, or tris(hydroxymethyl)aminomethane, or known during medical use as tromethamine or THAM, is an organic compound with the formula (HOCH2)3CNH2. It is extensively used in biochemistry and molecular biology as a component of buffer solutions such as in TAE and TBE buffers, especially for solutions of nucleic acids. It contains a primary amine and thus undergoes the reactions associated with typical amines, e.g., condensations with aldehydes. Tris also complexes with metal ions in solution. In medicine, tris (known as tromethamine) is occasionally used as a drug, given in intensive care for its properties as a buffer for the treatment of severe metabolic acidosis in specific circumstances. Some medications are formulated as the \"tromethamine salt\" including Hemabate (carboprost as trometamol salt), and \"ketorolac trometamol\". In 2023 a strain of Pseudomonas hunanensis was found to be able to degrade TRIS buffer."},"commercial":{"launchDate":"1965","_launchSource":"DrugCentral (FDA 1965-12-16, HOSPIRA)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2771","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=trometamol","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=trometamol","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Tris","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T16:10:00.827942","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:51:52.910671+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"trometamol","indications":{"approved":[{"name":"Allergic conjunctivitis","source":"DrugCentral","snomedId":473460002,"regulator":"FDA"},{"name":"Post-Op Ocular Inflammation","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Post-Op Photophobia","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Postoperative Ocular Pain","source":"DrugCentral","snomedId":"","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05488340","phase":"PHASE2","title":"A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)","status":"RECRUITING","sponsor":"Locus Biosciences","startDate":"2022-07-13","conditions":["Urinary Tract Infections"],"enrollment":318,"completionDate":"2026-12"},{"nctId":"NCT06112548","phase":"NA","title":"The Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral TKA","status":"COMPLETED","sponsor":"Damascus University","startDate":"2024-03-01","conditions":["Arthritis Knee","Pain","Arthroplasty Complications"],"enrollment":80,"completionDate":"2025-11-30"},{"nctId":"NCT03818932","phase":"PHASE2,PHASE3","title":"Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction","status":"COMPLETED","sponsor":"Henry Ford Health System","startDate":"2019-01-22","conditions":["Anterior Cruciate Ligament Injury"],"enrollment":90,"completionDate":"2020-05-20"},{"nctId":"NCT06978816","phase":"NA","title":"Ear Pressure Points Plus Pain Meds for Faster Kidney Stone Pain Relief","status":"RECRUITING","sponsor":"Gao Xiaofeng","startDate":"2025-06-01","conditions":["Renal Colic","Acupuncture, Ear"],"enrollment":116,"completionDate":"2026-12-01"},{"nctId":"NCT06201676","phase":"PHASE4","title":"Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients","status":"RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2025-02-28","conditions":["Orthopaedic Trauma","Chronic Opioid Use"],"enrollment":458,"completionDate":"2027-08-31"},{"nctId":"NCT05992883","phase":"PHASE3","title":"NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis","status":"RECRUITING","sponsor":"Mayo Clinic","startDate":"2023-07-28","conditions":["Thumb Osteoarthritis"],"enrollment":240,"completionDate":"2026-12-31"},{"nctId":"NCT07424625","phase":"PHASE4","title":"A Study of Tris-Hydroxymethyl Aminomethane (THAM) Versus Sodium Bicarbonate in Cardiac Surgical Patients","status":"NOT_YET_RECRUITING","sponsor":"Mayo Clinic","startDate":"2026-02","conditions":["Metabolic Acidosis"],"enrollment":250,"completionDate":"2027-08"},{"nctId":"NCT05543785","phase":"NA","title":"Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries","status":"RECRUITING","sponsor":"Mansoura University","startDate":"2022-11-01","conditions":["Postoperative Pain, Acute"],"enrollment":76,"completionDate":"2027-12-30"},{"nctId":"NCT06822751","phase":"PHASE3","title":"FOsfomycin for Male Urinary Tract Infection","status":"NOT_YET_RECRUITING","sponsor":"University Hospital, Rouen","startDate":"2026-03","conditions":["Urinary Tract Infection","Prostatitis","Cystitis"],"enrollment":138,"completionDate":"2029-06"},{"nctId":"NCT06878014","phase":"PHASE4","title":"Comparing the Safety and Effectiveness of Different Doses of Morphine Administered in Spinal Anethesia for Pain Relief After Hip Replacement Surgery","status":"RECRUITING","sponsor":"Medical University of Silesia","startDate":"2025-03-04","conditions":["Analgesics, Opioid","Anesthesia, Spinal","Total Hip Replacement","Adverse Anesthesia Outcome"],"enrollment":120,"completionDate":"2026-06-28"},{"nctId":"NCT03427736","phase":"","title":"Anesthetics and Analgesics in Children","status":"RECRUITING","sponsor":"Chi Dang Hornik","startDate":"2018-12-13","conditions":["Anesthesia","Pain"],"enrollment":460,"completionDate":"2026-09-09"},{"nctId":"NCT05865457","phase":"NA","title":"Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease","status":"RECRUITING","sponsor":"TRB Chemedica International SA","startDate":"2025-09-25","conditions":["Dry Eye Disease"],"enrollment":80,"completionDate":"2027-06"},{"nctId":"NCT05865379","phase":"NA","title":"Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease","status":"RECRUITING","sponsor":"TRB Chemedica International SA","startDate":"2026-03","conditions":["Dry Eye Disease"],"enrollment":80,"completionDate":"2027-06"},{"nctId":"NCT07386288","phase":"NA","title":"Short-term Perfusion Effects: Dexketoprofen/Tramadol","status":"COMPLETED","sponsor":"Ataturk University","startDate":"2024-11-01","conditions":["Renal Colic"],"enrollment":102,"completionDate":"2025-04-30"},{"nctId":"NCT07355907","phase":"NA","title":"Preoperative Prophylactic Fosfomycin Trometamol Versus 5-day Levofloxacin in Prevention of Postpercutaneous Nephrolithotomy Infectious Complications and Sepsis.","status":"COMPLETED","sponsor":"Tanta University","startDate":"2023-01-01","conditions":["Calculi, Renal","PCNL","Infectious Complications"],"enrollment":210,"completionDate":"2025-01-01"},{"nctId":"NCT05324358","phase":"PHASE3","title":"Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy","status":"COMPLETED","sponsor":"Neumentum, Inc.","startDate":"2022-12-14","conditions":["Pain, Postoperative"],"enrollment":341,"completionDate":"2024-09-06"},{"nctId":"NCT07352059","phase":"NA","title":"Midazolam Alone Versus Midazolam With Ketorolac for Sedation During Flexible Bronchoscopy.","status":"NOT_YET_RECRUITING","sponsor":"SYED HAIDER ALI","startDate":"2026-01-20","conditions":["Sedation and Analgesia Management in Patients Undergoing Flexible Bronchoscopy"],"enrollment":50,"completionDate":"2026-06-30"},{"nctId":"NCT04291599","phase":"PHASE2","title":"Initial Pain Management in Pediatric Pancreatitis: Opioid vs. Non-Opioid","status":"TERMINATED","sponsor":"Boston Children's Hospital","startDate":"2022-03-15","conditions":["Acute Pancreatitis"],"enrollment":23,"completionDate":"2025-07-24"},{"nctId":"NCT06326983","phase":"NA","title":"Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery","status":"RECRUITING","sponsor":"Boston Children's Hospital","startDate":"2024-05-09","conditions":["Tonsillitis","Post-operative Nausea and Vomiting (PONV)","Emergence Delirium","Opioid Analgesic Adverse Reaction","Anesthesia","Pain"],"enrollment":58,"completionDate":"2026-04-01"},{"nctId":"NCT05336266","phase":"EARLY_PHASE1","title":"A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Andrew Hendifar, MD","startDate":"2022-07-01","conditions":["Pancreas Cancer","Pancreatic Ductal Adenocarcinoma","Pancreatic Cancer"],"enrollment":28,"completionDate":"2026-12-05"},{"nctId":"NCT07305883","phase":"PHASE3","title":"Comparison of Intranasal Ketorolac and Intranasal Ketamine in Digital Nerve Block Pain","status":"NOT_YET_RECRUITING","sponsor":"Tehran University of Medical Sciences","startDate":"2025-12-28","conditions":["Pain","Digital Block"],"enrollment":64,"completionDate":"2026-08-01"},{"nctId":"NCT03888144","phase":"PHASE4","title":"Study of Ketorolac Versus Opioid for Pain After Endoscopy","status":"COMPLETED","sponsor":"The Cleveland Clinic","startDate":"2017-10-13","conditions":["Kidney Calculi","Ureteral Calculi"],"enrollment":81,"completionDate":"2021-08-01"},{"nctId":"NCT06513208","phase":"PHASE4","title":"Ketorolac Effects on Post-operative Pain and Lumbar Fusion","status":"RECRUITING","sponsor":"University of Maryland St. Joseph Medical Center","startDate":"2026-01","conditions":["Lumbar Spinal Fusion"],"enrollment":140,"completionDate":"2027-06"},{"nctId":"NCT03638999","phase":"EARLY_PHASE1","title":"NSAIDs Stent Study","status":"RECRUITING","sponsor":"Washington University School of Medicine","startDate":"2018-07-31","conditions":["Ureteral Stent Placement","Kidney Stone"],"enrollment":36,"completionDate":"2027-10"},{"nctId":"NCT01388413","phase":"PHASE4","title":"Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder","status":"COMPLETED","sponsor":"University Hospital, Tours","startDate":"2011-08","conditions":["Neurogenic Bladder","Urinary Tract Infection"],"enrollment":45,"completionDate":"2017-02"},{"nctId":"NCT07276906","phase":"PHASE4","title":"Comparing Intramuscular Fentanyl and Ketorolac With Nerve of Arnold (NOA) Block for Bilateral Myringotomy","status":"NOT_YET_RECRUITING","sponsor":"University of South Alabama","startDate":"2026-01","conditions":["Postoperative Pain"],"enrollment":300,"completionDate":"2026-08"},{"nctId":"NCT07248540","phase":"NA","title":"IV Magnesium in the Treatment of Acute Dysmenorrhea","status":"RECRUITING","sponsor":"Havva Betül Bacak","startDate":"2025-07-01","conditions":["Dysmenorrhea"],"enrollment":60,"completionDate":"2026-01-01"},{"nctId":"NCT07057752","phase":"PHASE2,PHASE3","title":"Virtual Reality for Pain and Anxiety Relief During Peripheral Angioplasty","status":"COMPLETED","sponsor":"Kastamonu University","startDate":"2025-08-01","conditions":["Peripheral Angioplasty","Pain Management","Virtual Reality"],"enrollment":52,"completionDate":"2025-10-29"},{"nctId":"NCT01667120","phase":"PHASE2","title":"The Use of Ketorolac in Surgical Neonates","status":"WITHDRAWN","sponsor":"Nationwide Children's Hospital","startDate":"2012-07","conditions":["Postoperative Pain Control in Surgical Neonates"],"enrollment":0,"completionDate":"2018-12-31"},{"nctId":"NCT03805607","phase":"PHASE4","title":"IV Ketorolac on Platelet Function Post-Cesarean Delivery","status":"COMPLETED","sponsor":"Beth Israel Deaconess Medical Center","startDate":"2021-01-18","conditions":["Analgesia, Obstetrical","Coagulation Defect; Postpartum","Nonsteroidals (NSAIDs)Toxicity","Postpartum Hemorrhage","Postoperative Pain","Ketorolac Adverse Reaction","Blood Loss, Postoperative"],"enrollment":40,"completionDate":"2024-03-30"},{"nctId":"NCT04763876","phase":"PHASE4","title":"Intramuscular Ketorolac at Two Single-Dose Regimens","status":"COMPLETED","sponsor":"William Beaumont Army Medical Center","startDate":"2020-06-27","conditions":["Musculoskeletal Pain","Analgesia","Adverse Event"],"enrollment":110,"completionDate":"2021-02-04"},{"nctId":"NCT03823534","phase":"PHASE3","title":"Post-Op Pain Control for Prophylactic Intramedullary Nailing.","status":"RECRUITING","sponsor":"St. Louis University","startDate":"2019-02-20","conditions":["Bone Metastases","Lymphoma","Multiple Myeloma","Opioid Use","Pain"],"enrollment":60,"completionDate":"2026-12-31"},{"nctId":"NCT07176572","phase":"PHASE4","title":"Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation and Dexketoprofen in Renal Colic","status":"NOT_YET_RECRUITING","sponsor":"Adiyaman University Research Hospital","startDate":"2026-03-01","conditions":["Renal Colic"],"enrollment":128,"completionDate":"2026-12-31"},{"nctId":"NCT06475274","phase":"PHASE2","title":"A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery","status":"COMPLETED","sponsor":"Guard Therapeutics AB","startDate":"2024-08-26","conditions":["Kidney Injury Following Open-Chest Cardiac Surgery"],"enrollment":170,"completionDate":"2025-09-11"},{"nctId":"NCT03513770","phase":"EARLY_PHASE1","title":"Autonomic Control of the Circulation and VDR","status":"RECRUITING","sponsor":"Milton S. Hershey Medical Center","startDate":"2019-08-14","conditions":["Venous Distension Reflex","Blood Pressure"],"enrollment":18,"completionDate":"2026-05-30"},{"nctId":"NCT02128646","phase":"PHASE4","title":"Liposomal Bupivacaine (Exparel) for Postoperative Pain Control for Open and Laparoscopic Abdominal Hernia Repair","status":"COMPLETED","sponsor":"University of Kansas Medical Center","startDate":"2014-04","conditions":["Pain"],"enrollment":19,"completionDate":"2017-01"},{"nctId":"NCT04959331","phase":"PHASE4","title":"Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women.","status":"COMPLETED","sponsor":"Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina","startDate":"2021-11-02","conditions":["Urinary Tract Infections"],"enrollment":1000,"completionDate":"2024-12-31"},{"nctId":"NCT05842044","phase":"PHASE2","title":"NSAID Use After Robotic Partial Nephrectomy","status":"RECRUITING","sponsor":"University of Miami","startDate":"2023-09-15","conditions":["Kidney Cancer","Renal Cancer","Renal Neoplasm"],"enrollment":110,"completionDate":"2026-09-30"},{"nctId":"NCT05575999","phase":"PHASE1","title":"Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain","status":"NOT_YET_RECRUITING","sponsor":"Kansas City Heart Rhythm Research Foundation","startDate":"2026-01","conditions":["Pain Management"],"enrollment":200,"completionDate":"2026-12"},{"nctId":"NCT05037812","phase":"EARLY_PHASE1","title":"Role of Multimodal Analgesia in Decreasing Perioperative Pain in Tibial Plateau Fractures","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Utah","startDate":"2019-03-25","conditions":["Tibial Plateau Fractures"],"enrollment":150,"completionDate":"2026-03"},{"nctId":"NCT05019638","phase":"EARLY_PHASE1","title":"Local Multimodal Injection Versus Regional Anesthesia in Controlling Pain for Treating Rotational Ankle Fractures","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Utah","startDate":"2021-05-15","conditions":["Ankle Fractures"],"enrollment":200,"completionDate":"2026-05"},{"nctId":"NCT06973785","phase":"PHASE3","title":"Non-Narcotic Pain Control After ACL Reconstruction","status":"RECRUITING","sponsor":"The Cleveland Clinic","startDate":"2025-07-15","conditions":["ACL - Anterior Cruciate Ligament Rupture","ACL Injuries"],"enrollment":30,"completionDate":"2026-12-31"},{"nctId":"NCT07047040","phase":"PHASE2,PHASE3","title":"Analgesic Efficacy of Pre-operative Dose of Ketorolac and Gabapentin","status":"NOT_YET_RECRUITING","sponsor":"Assiut University","startDate":"2025-08-15","conditions":["Pain, Postoperative","Osteoarthritis, Knee"],"enrollment":86,"completionDate":"2027-12-30"},{"nctId":"NCT07057934","phase":"NA","title":"Comparative Efficacy of ESPB and EOPB for Postoperative Analgesia in Laparoscopic Cholecystectomy: A Randomized Controlled Trial (External Oblique Intercostal Plan Block (EOPB) and Erector Spina Plan Block (ESPB) )","status":"COMPLETED","sponsor":"Dr. Lutfi Kirdar Kartal Training and Research Hospital","startDate":"2024-04-01","conditions":["Postoperative Pain","Cholelithiasis","Acute Pain"],"enrollment":90,"completionDate":"2024-06-30"},{"nctId":"NCT05641363","phase":"PHASE3","title":"Comparison of Ketorolac at Three Doses in Children With Acute Pain","status":"COMPLETED","sponsor":"Hamilton Health Sciences Corporation","startDate":"2023-06-01","conditions":["Acute Pain","Abdominal Pain","Migraine","Appendicitis Acute","Renal Colic","Biliary Colic"],"enrollment":171,"completionDate":"2025-05-06"},{"nctId":"NCT06150898","phase":"PHASE2","title":"Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)","status":"RECRUITING","sponsor":"Jules Bordet Institute","startDate":"2025-05-12","conditions":["Early-stage Breast Cancer","Estrogen-receptor-positive Breast Cancer"],"enrollment":112,"completionDate":"2027-10"},{"nctId":"NCT03671746","phase":"PHASE1","title":"Inflammatory Markers in Trauma Patient Outcomes","status":"COMPLETED","sponsor":"Arun Aneja","startDate":"2019-02-28","conditions":["Polytrauma"],"enrollment":70,"completionDate":"2023-06-20"},{"nctId":"NCT06853327","phase":"PHASE2","title":"Oral Ketorolac for IUD Pain Reduction","status":"ENROLLING_BY_INVITATION","sponsor":"University of North Carolina, Chapel Hill","startDate":"2025-05-23","conditions":["IUD Insertion Pain"],"enrollment":108,"completionDate":"2026-06-30"},{"nctId":"NCT06210126","phase":"NA","title":"Pectointercostal Fascial Plane Block Chronic Pain Sternotomy","status":"COMPLETED","sponsor":"Konya Meram State Hospital","startDate":"2024-01-18","conditions":["Chronic Pain"],"enrollment":50,"completionDate":"2025-05-28"},{"nctId":"NCT02470299","phase":"NA","title":"Evaluation of GTPase Inhibition by Post-operative Intravenous Ketorolac in Ovarian Cancer Patients","status":"COMPLETED","sponsor":"New Mexico Cancer Research Alliance","startDate":"2015-10-29","conditions":["Ovarian Cancer","Fallopian Tube Cancer","Peritoneal Cancer"],"enrollment":21,"completionDate":"2024-01-25"},{"nctId":"NCT06954896","phase":"","title":"Comparison of Superior Hypogastric Plexus Block and Peritoneal Bupivacaine in Pain Management","status":"COMPLETED","sponsor":"Enes Celik","startDate":"2024-07-01","conditions":["Superior Hypogastric Plexus Block","Intraperitoneal Bupivacaine"],"enrollment":94,"completionDate":"2025-02-20"},{"nctId":"NCT02604537","phase":"PHASE4","title":"Betamethasone Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis","status":"COMPLETED","sponsor":"OrthoCarolina Research Institute, Inc.","startDate":"2015-10-15","conditions":["DeQuervain Tendinopathy"],"enrollment":64,"completionDate":"2024-10-30"},{"nctId":"NCT05512949","phase":"PHASE2","title":"Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2022-09-09","conditions":["Monkeypox"],"enrollment":229,"completionDate":"2025-02-24"},{"nctId":"NCT06932367","phase":"PHASE4","title":"The Efficacy of Dexketoprofen And Methylprednisolone in the Acute Low Back Pain","status":"COMPLETED","sponsor":"Ali Gur","startDate":"2021-08-01","conditions":["Low Back Pain"],"enrollment":150,"completionDate":"2025-01-02"},{"nctId":"NCT06916234","phase":"PHASE4","title":"Evaluation of the Analgesic Efficacy of the Combination of Dexketoprofen + Paracetamol and the Combination of Naproxen Sodium + Codeine in Patients With Acute Dental Pain","status":"COMPLETED","sponsor":"ibrahim doğru","startDate":"2023-01-10","conditions":["Acute Dental Pain"],"enrollment":100,"completionDate":"2024-01-20"},{"nctId":"NCT02641639","phase":"PHASE2,PHASE3","title":"FOCUS: PCC + Bevacizumab + CA4P Versus PCC + Bevacizumab + Placebo for Subjects With Platinum Resistant Ovarian Cancer","status":"TERMINATED","sponsor":"Mateon Therapeutics","startDate":"2016-06","conditions":["Platinum Resistant Ovarian Cancer"],"enrollment":70,"completionDate":"2017-10"},{"nctId":"NCT06365632","phase":"PHASE2","title":"Clinical Study of the Effectiveness, Tolerability and Safety of the Drug \"Anti-spike, Gel, 100 g in Bottles in Package No. 1\" Produced by the Republican Unitary Enterprise \"Unitekhprom BSU\", With a Single Intraperitoneal Use After Surgery in Adult Patients With Acute Phlegmonous Appendicitis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Research Institute for Physical Chemical Problems of the Belarusian State University","startDate":"2025-03-19","conditions":["Abdominal Adhesions"],"enrollment":100,"completionDate":"2025-12"},{"nctId":"NCT05102591","phase":"PHASE3","title":"A Pilot Clinical Trial of a New Neuromodulation Device for Acute Attacks of Migraine in Children and Adolescents","status":"COMPLETED","sponsor":"University of Calgary","startDate":"2022-02-22","conditions":["Migraine Disorders"],"enrollment":22,"completionDate":"2024-08-29"},{"nctId":"NCT04495894","phase":"PHASE2","title":"Pre-Incisional Ketorolac for Patients Undergoing Surgery for Non-Small Cell Lung Cancer and Renal Cell Carcinoma","status":"TERMINATED","sponsor":"Emory University","startDate":"2020-08-24","conditions":["Non-small Cell Lung Cancer","Renal Cell Carcinoma"],"enrollment":68,"completionDate":"2024-02-01"},{"nctId":"NCT06285409","phase":"NA","title":"Comparing the Dose-response Profiles of Uterotonics After Initial Carbetocin Administration - an Ex-vivo Study in Desensitized Human Myometrium","status":"RECRUITING","sponsor":"Samuel Lunenfeld Research Institute, Mount Sinai Hospital","startDate":"2024-04-04","conditions":["Postpartum Hemorrhage"],"enrollment":32,"completionDate":"2025-12"},{"nctId":"NCT03987022","phase":"PHASE4","title":"ICE-T Pain Regimen for Total Laparoscopic Hysterectomy","status":"COMPLETED","sponsor":"MetroHealth Medical Center","startDate":"2019-08-01","conditions":["Opioid Substitution Treatment"],"enrollment":66,"completionDate":"2022-04-25"},{"nctId":"NCT05170841","phase":"PHASE4","title":"Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low Back Pain","status":"COMPLETED","sponsor":"Menarini International Operations Luxembourg SA","startDate":"2020-09-17","conditions":["Low Back Pain"],"enrollment":538,"completionDate":"2022-05-04"},{"nctId":"NCT04894864","phase":"PHASE4","title":"Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair","status":"RECRUITING","sponsor":"University of Crete","startDate":"2020-10-08","conditions":["Elective Surgical Procedures","Postoperative Pain","Anesthesia","Opioid Use","Abdominal Aortic Aneurysm Without Rupture","Vascular Surgical Procedure","Interleukin 6","Immunomodulators"],"enrollment":40,"completionDate":"2027-10-08"},{"nctId":"NCT03913702","phase":"PHASE2","title":"Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement","status":"TERMINATED","sponsor":"The University of Texas Medical Branch, Galveston","startDate":"2019-09-09","conditions":["Subacromial Impingement","Subacromial Impingement Syndrome"],"enrollment":1,"completionDate":"2022-11-02"},{"nctId":"NCT05190341","phase":"PHASE4","title":"Ibuprofen Versus Ketorolac for Pain Relief During Hysterosalpingogram","status":"TERMINATED","sponsor":"Madigan Army Medical Center","startDate":"2022-03-24","conditions":["Infertility, Female"],"enrollment":12,"completionDate":"2024-10-10"},{"nctId":"NCT04528173","phase":"PHASE4","title":"Opioid-Free Anesthetic for Tonsillectomy","status":"TERMINATED","sponsor":"Children's Hospital of Philadelphia","startDate":"2020-07-22","conditions":["Anesthesia","Opioid Use","Tonsillitis","Sleep Disorder","Surgery"],"enrollment":35,"completionDate":"2023-08-22"},{"nctId":"NCT05176158","phase":"NA","title":"Dexketoprofen Dosage According to Chronotherapy","status":"COMPLETED","sponsor":"Universidad Complutense de Madrid","startDate":"2024-11-01","conditions":["Tooth, Impacted","Trismus","Pain","Inflammatory Response"],"enrollment":10,"completionDate":"2024-11-01"},{"nctId":"NCT03472872","phase":"PHASE4","title":"A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache","status":"WITHDRAWN","sponsor":"Corewell Health South","startDate":"2017-09-05","conditions":["Headache"],"enrollment":0,"completionDate":"2020-06-14"},{"nctId":"NCT06681688","phase":"PHASE1,PHASE2","title":"Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC","status":"RECRUITING","sponsor":"Inder Paul Singh, M.D.","startDate":"2024-07-10","conditions":["Cataract"],"enrollment":94,"completionDate":"2025-08"},{"nctId":"NCT04895280","phase":"PHASE4","title":"Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections","status":"WITHDRAWN","sponsor":"Michael Khazzam","startDate":"2024-11","conditions":["Full-thickness Rotator Cuff Tear","Rotator Cuff Tendinitis"],"enrollment":0,"completionDate":"2028-11"},{"nctId":"NCT05001555","phase":"PHASE3","title":"Efficacy and Safety of Dexketoprofen/Vitamin B Vs Dexketoprofen for Post-traumatic Cervical Sprain Grade I-II","status":"COMPLETED","sponsor":"Laboratorios Silanes S.A. de C.V.","startDate":"2021-11-23","conditions":["Acute Low Back Pain"],"enrollment":174,"completionDate":"2023-04-25"},{"nctId":"NCT05158699","phase":"PHASE3","title":"Effectiveness of Periocular Drug Injection in CATaract Surgery","status":"TERMINATED","sponsor":"Luigi Rondas","startDate":"2021-10-13","conditions":["Macular Edema","Cystoid Macular Edema","Retinal Disease","Cataract","Lens Diseases","Eye Diseases"],"enrollment":628,"completionDate":"2024-08-13"},{"nctId":"NCT05238025","phase":"PHASE3","title":"MVA-BN-RSV Vaccine Trial","status":"TERMINATED","sponsor":"Bavarian Nordic","startDate":"2022-04-19","conditions":["Respiratory Syncytial Virus Infections"],"enrollment":20419,"completionDate":"2023-09-01"},{"nctId":"NCT06659016","phase":"PHASE4","title":"Efficacy of Collagen, Propolis Plus Quercetin (Proqutin®), Bacillus Coagulans, Hyaluronic Acid and Chondroitin Sulphate and D-Mannose to Avoid Symptoms and Prevents Recurrence in Women With Recurrent Urinary Tract Infections","status":"COMPLETED","sponsor":"University of Campania Luigi Vanvitelli","startDate":"2023-02-01","conditions":["Urinary Tract Infection (Diagnosis)"],"enrollment":148,"completionDate":"2024-09-30"},{"nctId":"NCT03453541","phase":"PHASE4","title":"Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy","status":"TERMINATED","sponsor":"Albany Medical College","startDate":"2017-11-21","conditions":["Analgesic Adverse Reaction"],"enrollment":214,"completionDate":"2022-11-01"},{"nctId":"NCT05028257","phase":"PHASE3","title":"Allergy and COVID-19 Vaccines","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2021-09-15","conditions":["Anaphylactic Reaction","Vaccine Reaction"],"enrollment":117,"completionDate":"2023-05-22"},{"nctId":"NCT06222320","phase":"PHASE2,PHASE3","title":"Kinesiotaping Method for Rib Fractures","status":"COMPLETED","sponsor":"Kastamonu University","startDate":"2024-01-24","conditions":["Rib Fractures","Pain, Chest"],"enrollment":34,"completionDate":"2024-10-01"},{"nctId":"NCT06620718","phase":"NA","title":"Evaluation of Root Migration Distance After Coronectomy of Impacted Third Molars","status":"COMPLETED","sponsor":"Mustafa Kemal University","startDate":"2021-01-01","conditions":["Impacted Tooth With Abnormal Positioning"],"enrollment":73,"completionDate":"2022-12-30"},{"nctId":"NCT06616922","phase":"PHASE2","title":"Assessment of the Effects and Tolerability of RD03/2016 for the Treatment of Bacterial Conjunctivitis in Adults","status":"COMPLETED","sponsor":"NTC srl","startDate":"2021-11-05","conditions":["Conjunctivitis, Bacterial"],"enrollment":252,"completionDate":"2023-09-19"},{"nctId":"NCT04733326","phase":"PHASE1","title":"Evaluation of Post-operative Pain and Expression of IL-8 Using Ketolac or Cryoirrigation as a Final Flush in Single Visit Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis.Randomized Clinical Trial.","status":"COMPLETED","sponsor":"Cairo University","startDate":"2021-09-01","conditions":["Post-operative Pain"],"enrollment":48,"completionDate":"2023-03-01"},{"nctId":"NCT05518812","phase":"EARLY_PHASE1","title":"Carboprost (Hemabate) for Fibroid Resection","status":"COMPLETED","sponsor":"Northwestern University","startDate":"2022-07-12","conditions":["Fibroid Uterus","Gynecologic Disease","Leiomyoma, Uterine"],"enrollment":19,"completionDate":"2024-05-06"},{"nctId":"NCT03467750","phase":"PHASE4","title":"Effect of Ketorolac on Post Adenotonsillectomy Pain","status":"COMPLETED","sponsor":"Emory University","startDate":"2018-07-19","conditions":["Obstructive Sleep Apnea"],"enrollment":63,"completionDate":"2023-08-22"},{"nctId":"NCT06584188","phase":"PHASE2","title":"The Effect of Anti-inflammatory Cryoagent on the Level of Postoperative Pain in Patients with Symptomatic Irreversible Pulpitis and Apical Periodontitis.","status":"NOT_YET_RECRUITING","sponsor":"Ain Shams University","startDate":"2024-11-01","conditions":["Postoperative Pain"],"enrollment":60,"completionDate":"2025-09-30"},{"nctId":"NCT06579703","phase":"PHASE4","title":"Ketorolac for Acute Vaso-Occlusive Crisis in Pediatric Sickle Cell Disease","status":"NOT_YET_RECRUITING","sponsor":"Children's Blood and Cancer Center at Dell Children's Medical Center","startDate":"2024-09-30","conditions":["Sickle Cell Disease","Sickle Cell Crisis","Veno-occlusive Disease"],"enrollment":102,"completionDate":"2028-02-15"},{"nctId":"NCT06563271","phase":"PHASE4","title":"Approach to Ankle Sprains in the Emergency Department","status":"COMPLETED","sponsor":"Ankara Etlik City Hospital","startDate":"2023-12-01","conditions":["Ankle Sprains"],"enrollment":150,"completionDate":"2024-06-01"},{"nctId":"NCT06558916","phase":"PHASE4","title":"Comparison of the Analgesic Efficacy of Dexketoprofen Trometamol, Meperidine, and Paracetamol in Renal Colic","status":"COMPLETED","sponsor":"Ismail Tekin","startDate":"2015-10","conditions":["Analgesia","Renal Colic"],"enrollment":90,"completionDate":"2015-12"},{"nctId":"NCT02509143","phase":"NA","title":"Acupuncture for Postoperative Nausea and Vomiting in Patients Undergoing Colorectal Surgery","status":"COMPLETED","sponsor":"Pusan National University Yangsan Hospital","startDate":"2015-07","conditions":["Postoperative Nausea and Vomiting","Colorectal Neoplasms"],"enrollment":60,"completionDate":"2016-12"},{"nctId":"NCT06539637","phase":"EARLY_PHASE1","title":"Ketorolac Levels in Vitreous and Aqueous Samples From Patients Undergoing Combined Cataract and Pars Plana Vitrectomy Surgeries With and Without Intracameral Phenylephrine 1.0% / Ketorolac 0.3%","status":"RECRUITING","sponsor":"DHS Consulting","startDate":"2023-09-01","conditions":["Cataract"],"enrollment":20,"completionDate":"2026-02"},{"nctId":"NCT04646967","phase":"PHASE2","title":"An Evaluation of Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision","status":"COMPLETED","sponsor":"Alberta Children's Hospital","startDate":"2022-11-25","conditions":["Pain, Postoperative","Phimosis","Paraphimosis","Balanitis"],"enrollment":100,"completionDate":"2024-01-25"},{"nctId":"NCT05875571","phase":"PHASE4","title":"Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement","status":"RECRUITING","sponsor":"Arkansas Children's Hospital Research Institute","startDate":"2024-02-05","conditions":["IUD","Healthy Female","Contraception","IUD Insertion Complication"],"enrollment":18,"completionDate":"2025-06"},{"nctId":"NCT05861791","phase":"NA","title":"Comparison of Patient-controlled Analgesia Regimenfor Postoperative Pain in Patients Undergoing Total Knee Arthroplasty","status":"COMPLETED","sponsor":"Chung-Ang University Gwangmyeong Hospital","startDate":"2023-02-07","conditions":["Postoperative Pain, Acute"],"enrollment":98,"completionDate":"2024-07-12"},{"nctId":"NCT06498440","phase":"PHASE4","title":"Efficacy of NSAID vs. Steroid-NSAID Combo Post-Selective Laser Trabeculoplasty: Phase 4, Single-Center RCT","status":"NOT_YET_RECRUITING","sponsor":"St. Joseph's Healthcare Hamilton","startDate":"2024-09-01","conditions":["Open Angle Glaucoma","Ocular Hypertension","Postoperative Inflammation"],"enrollment":126,"completionDate":"2025-07-01"},{"nctId":"NCT06484439","phase":"EARLY_PHASE1","title":"Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction","status":"COMPLETED","sponsor":"United States Naval Medical Center, San Diego","startDate":"2018-02-14","conditions":["Pain, Post-operative","Third Molar","Oral Surgery","Pain, Acute"],"enrollment":80,"completionDate":"2021-12-01"},{"nctId":"NCT06395428","phase":"PHASE4","title":"Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department","status":"RECRUITING","sponsor":"Western Michigan University School of Medicine","startDate":"2024-07-09","conditions":["Back Pain","Chronic Pain"],"enrollment":75,"completionDate":"2027-04-15"},{"nctId":"NCT05591105","phase":"","title":"The Postoperative Lidocaine and Ketamine Effects on Morphine Requirement in Bariatric Surgery","status":"COMPLETED","sponsor":"Tiva Group","startDate":"2023-06-15","conditions":["Pharmacological Action","Post Operative Pain","Opioid Use","Obesity, Morbid","Anesthesia Morbidity"],"enrollment":64,"completionDate":"2024-01-31"},{"nctId":"NCT06160778","phase":"PHASE3","title":"Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain","status":"RECRUITING","sponsor":"University of Calgary","startDate":"2024-05-27","conditions":["Acute Pain","Abdomen, Acute","Abdominal Pain","Appendicitis","Emergencies","Child, Only"],"enrollment":495,"completionDate":"2029-12"},{"nctId":"NCT05709028","phase":"PHASE3","title":"Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections","status":"RECRUITING","sponsor":"University of Sydney","startDate":"2023-08-02","conditions":["Urinary Tract Infections"],"enrollment":300,"completionDate":"2027-08"},{"nctId":"NCT06404177","phase":"PHASE3","title":"Enantyum® IV Versus Piroxen® IM in Emergency Pain Management","status":"RECRUITING","sponsor":"Riadh Boukef","startDate":"2023-07-15","conditions":["Traumatic Injury"],"enrollment":300,"completionDate":"2024-08-30"},{"nctId":"NCT05545137","phase":"PHASE3","title":"Clinical Trial of Pivmecillinam Hydrochloride Tablets in the Treatment of Uncomplicated Urinary Tract Infection","status":"COMPLETED","sponsor":"Benova (Tianjin) Innovative medicine Research Co., Ltd.","startDate":"2022-09-29","conditions":["Uncomplicated Urinary Tract Infection"],"enrollment":299,"completionDate":"2024-02-20"},{"nctId":"NCT06317922","phase":"NA","title":"Evaluation of Dry Eye Disease's Signs in Patients Who Were Administered Intravitreal Anti-VEGF Injections","status":"RECRUITING","sponsor":"Francesco Bandello","startDate":"2024-02-05","conditions":["Dry Eye Syndromes"],"enrollment":60,"completionDate":"2025-05-12"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Intravenous","formulation":"Cream, Injection","formulations":[{"form":"CREAM","route":"TOPICAL","productName":"Anubis Barcelona Protective Line"},{"form":"CREAM","route":"TOPICAL","productName":"AnubisMed"},{"form":"CREAM","route":"TOPICAL","productName":"SOORYEHAN HYO FERMENTED SUN BLOCK"},{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","productName":"THAM"}]},"crossReferences":{"NUI":"N0000146434","MMSL":"5644","NDDF":"000751","UNII":"023C2WHX2V","VUID":"4018096","CHEBI":"CHEBI:9754","VANDF":"4018096","INN_ID":"1108","RXNORM":"10865","UMLSCUI":"C0041175","chemblId":"CHEMBL3186668","ChEMBL_ID":"CHEMBL1200391","KEGG_DRUG":"D00396","DRUGBANK_ID":"DB03754","PDB_CHEM_ID":"TMN","PUBCHEM_CID":"6503","SNOMEDCT_US":"404882002","IUPHAR_LIGAND_ID":"7328","MESH_DESCRIPTOR_UI":"D014325"},"formularyStatus":[],"originalProduct":{"form":"INJECTION, SOLUTION","route":"INTRAVENOUS","company":"Hospira, Inc.","brandName":"THAM","isOriginal":true,"marketingStatus":"NDA"},"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"1965-","companyName":"Pfizer","relationship":"Original Developer"}],"publicationCount":552,"therapeuticAreas":["Ophthalmology"],"atcClassification":{"source":"DrugCentral","atcCode":"B05BB03","allCodes":["B05BB03","B05XX02"]},"biosimilarFilings":[],"originalDeveloper":"Hospira","recentPublications":[{"date":"2026 Mar 12","pmid":"41817910","title":"Analysis of the efficacy of fosfomycin trometamol in preventing biofilm bacterial infection in double-J stents among diabetic patients and the factors associated with infection.","journal":"International urology and nephrology"},{"date":"2026 Jan","pmid":"41782795","title":"From Needle to Sachet: Fosfomycin Versus Amikacin for Cystoscopy Prophylaxis.","journal":"Cureus"},{"date":"2026 Feb 14","pmid":"41718138","title":"Ciprofloxacin Versus Fosfomycin for Empirical Prophylaxis Before Transrectal Prostate Biopsy: Clinical, Microbiological, and Patient-Reported Outcomes from a Prospective Study.","journal":"Medical sciences (Basel, Switzerland)"},{"date":"2026 Apr","pmid":"41714094","title":"A Robust LC-MS/MS Bioanalytical Strategy for Simultaneous Quantification of Tramadol HCl and Dexketoprofen Trometamol and Its Use in Pharmacokinetic Studies.","journal":"Biomedical chromatography : BMC"},{"date":"2026 Jan 4","pmid":"41594090","title":"Prevalence of and Factors Associated with Antibiotic Prescription in Gynecological Practices in Germany.","journal":"Antibiotics (Basel, Switzerland)"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"Pfizer","companyId":"pfizer","modality":"Small Molecule","firstApprovalDate":"1965","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1965-12-16T00:00:00.000Z","mah":"HOSPIRA","brand_name_local":null,"application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1965-12-16T00:00:00.000Z","mah":"HOSPIRA","brand_name_local":"THAM","application_number":"NDA013025"},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:51:52.910671+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}