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NCT04013958
Comparison of Treatment by IM Ketamine to IV Ketamine in Patients With Renal Colic
Phase 3 trial testing IV Ketamine in Acute Pain in 100 participants. Status unknown.
1 August 2021
Quick facts
| Lead sponsor | Tel-Aviv Sourasky Medical Center |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 100 |
| Start date | 1 August 2019 |
| Primary completion | 1 August 2021 |
| Estimated completion | 1 August 2021 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- IV Ketamine — full drug profile →
- IM Ketamine — full drug profile →
Conditions studied
- Acute Pain — all drugs for Acute Pain →
- Renal Colic — all drugs for Renal Colic →
Sponsor
Tel-Aviv Sourasky Medical Center
Who can join
Adults 18 to 70, any sex, with Acute Pain or Renal Colic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients who present to the emergency department (ED), with acute pain due to renal colic, are often treated with opioids. Treatment with opioids has many disadvantages - cardio-respiratory depression, nausea, vomiting and long term dependence. For these reasons, there is a constant search for a way to reduce the use of opioids. ketamine has been proven to augmented the analgesic effect of opioids, and thus reduce the use and adverse effects of opioids. Different studies about the use of Ketamine as a sedition agent have shown that Ketamine given IM versus IV has longer duration of effect with less adverse effects. The study we are conducting is designed to test and analyze the safety and efficacy of IV Ketamine with IV Morphine compared to IV Ketamine and morphine with IM placebo in a setting of acute pain due to, or suspected renal colic in the ED. When both ways of administration are given by the protocol as is customary for treatment of pain in the Emergency Medicine department, and will be a prospective, randomized, double blind, controlled study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04013958
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04013958 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tel-Aviv Sourasky Medical Center
- Last refreshed: 10 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04013958.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing