Clinical Trial

Sterile Water Injection vs Morphine for Renal Colic

Study acronym: ISWI-Morph
Active, Not Recruiting
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Record status
This record was last updated January 30, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
This study aims to compare intradermal sterile water injections (ISWI) with intravenous morphine for pain relief in adults with acute renal colic caused by urinary stones. Renal colic is a common emergency characterized by sudden, severe flank pain. Rapid and effective pain control is critical for proper diagnosis and treatment. Traditional pain management uses NSAIDs or opioids like morphine, which can cause side effects or be limited in certain patients. ISWI is a simple, low-cost, non-systemic method that may provide rapid pain relief by stimulating skin nerves, which can reduce pain signals in the spinal cord and brain. In this randomized, controlled, double-blind trial, adult patients with confirmed renal stones and pain ≥4/10 on the visual analog scale (VAS) will be assigned to one of three groups: 1. Single ISWI injection 2. Four ISWI injections 3. Intravenous morphine Pain will be measured at 5, 30, 45, and 90 minutes after treatment. The main goal is to determine whether ISWI is not inferior to morphine in reducing pain at 30 minutes. Secondary goals include comparing the speed and intensity of pain relief between one versus four injections, the need for additional pain medication, and patient satisfaction. All patients will be monitored for safety, and adverse effects will be recorded. The study follows strict ethical guidelines, including informed consent. If successful, ISWI could provide a safe, effective, and easily available alternative to morphine for rapid pain relief in renal colic, with minimal side effects, and guide the best injection strategy for optimal patient comfort.
Trial Details
NCT Number NCT07378904
Lead Sponsor University Tunis El Manar
Conditions Renal Colic, Urolithiasis
Enrollment 150 participants
Start Date 2026-01-20
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-30