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IM vs IV Ketamine for Renal Colic
NCT04013958Phase 3
Key facts
- Status
- Unknown
- Start
- Aug 2019
- Primary completion
- Aug 2021
- Countries
- 1
- Sponsor
- Tel Aviv Sourasky Medical Center
- Modality
- Small Molecules
- Drugs
- ketamine
- Conditions
- Renal colic
01
Overview
Phase 3, randomised, double-blind trial of ketamine in Renal colic (2 arms), sponsored by Tel Aviv Sourasky Medical Center. Primary endpoints: Effectiveness of IM Ketamine in decreasing pain intensity at 1.5 hours and Adverse effects at 1.5 hours. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
IV Ketamine
IV Ketamine 0.1 mg/kg + IV Morphine 0.1 mg/kg + IM Placebo
IM Ketamine
IM Ketamine 0.3 mg/kg + IV Morphine 0.1 mg/kg
03
Who it enrols
Adult patients (18-70 years) with acute renal colic pain >= 7/10, weighing 50-100 kg, with SBP 90-180 mmHg and ASA score 1-2. Excludes patients who received opioids within 6 hours, chronic analgesia users, pregnant women, and those with psychiatric history or allergies to study drugs.
04
Endpoints
Primary
Effectiveness of IM Ketamine in decreasing pain intensity
Adverse effects
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