Sterile Water Injection vs Morphine for Renal Colic (ISWI-Morph)

University Tunis El Manar

Status: Active, not recruiting

Conditions: Urolithiasis; Renal Colic

Treatments: Drug: Intravenous Morphine; Procedure: Multiple Intradermal Sterile Water Injections; Procedure: Single Intradermal Sterile Water Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07378904

HTHEC-2026-02

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18 years or older
• Acute renal colic with pain score ≥ 4 on the Visual Analog Scale (VAS)
• Urolithiasis confirmed by low-dose abdominopelvic CT scan
• Ability to provide written informed consent

Exclusion criteria

• Absence of urinary stones on imaging
• Known allergy or contraindication to morphine or sterile water injection
• Severe renal failure
• Local skin infection at the injection site
• Pregnancy or breastfeeding
• Inability to understand the study or provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Single Intradermal Sterile Water Injection (1 ISWI)

Experimental group

Description:

Participants receive 0.5 ml of sterile water injected intradermally at the point of maximal pain in the thoraco-lumbar region (T11-L4). Pain relief is assessed at 5, 30, 45, and 90 minutes.

Treatment:

Procedure: Single Intradermal Sterile Water Injection

Multiple Intradermal Sterile Water Injections (4 ISWI)

Experimental group

Description:

Participants receive 1 ml of sterile water divided into four intradermal injections of 0.25 ml each, spaced around the point of maximal pain in the thoraco-lumbar region (T11-L4). Pain relief is assessed at 5, 30, 45, and 90 minutes.

Treatment:

Procedure: Multiple Intradermal Sterile Water Injections

Intravenous Morphine

Active Comparator group

Description:

Participants receive intravenous morphine at a dose of 0.1 mg/kg, administered according to local emergency protocols. Pain relief is assessed at 5, 30, 45, and 90 minutes.

Treatment:

Drug: Intravenous Morphine