Last reviewed · How we verify
Duramorph
At a glance
| Generic name | Duramorph |
|---|---|
| Also known as | Spinal Duramorph, duramorph versus placebo |
| Sponsor | Virginia Commonwealth University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF DURAMORPH Risks with Neuraxial Administration Single-dose neuraxial administration may result in acute or delayed respiratory depression up to 24 hours. Because of the risk of severe adverse reactions when DURAMORPH is administered by the epidural or intrathecal route of administration, patients must be observed in a fully equipped and staffed environment for at least 24 hours after the initial dose [see Warnings and Precautions (5.1) ]. Ad
Common side effects
- Nausea
- Constipation
- Vomiting
- Generalized pruritus
- Dizziness
- Headache
- Urinary retention
- Confusion
- Euphoria
- Anxiety
- Urticaria
- Wheals
Serious adverse events
- Respiratory depression
- Respiratory arrest
- Serotonin syndrome
- Anaphylaxis
- Adrenal insufficiency
- Seizures
- Toxic psychosis
- Hyperalgesia and Allodynia
- Opioid-induced esophageal dysfunction
- Myoclonus
Key clinical trials
- Examining Analgesic Synergy and Efficacy in Trauma Care (PHASE4)
- Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma (PHASE3)
- Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine vs Oral Morphine (PHASE3)
- Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome (PHASE2)
- Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion (EARLY_PHASE1)
- Comparison of Non-Invasive Respiratory Monitoring System (RMS)
- Intercostal Nerve Cryoablation Versus Epidural Analgesia for Nuss Repair of Pectus Excavatum (NA)
- Analgesic Effects of Intrathecal Morphine and Transversalis Plane Block After Cesarean Delivery
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |