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NCT Number: NCT07378904

Sterile Water Injection vs Morphine for Renal Colic

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Renal Colic Agnosia Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Habib Thameur Teaching Hospital

Tunis, Tunis Governorate, 1008, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single Intradermal Sterile Water Injection

Procedure

single 0.5 ml sterile water injection is administered intradermally at the point of maximal pain in the thoraco-lumbar region (T11-L4). Pain will be assessed at 5, 30, 45, and 90 minutes.

Multiple Intradermal Sterile Water Injections

Procedure

1 ml sterile water is 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 will be assessed at 5, 30, 45, and 90 minutes.

intravenous morphine

Drug

Morphine is administered intravenously at 0.1 mg/kg according to local emergency protocols. Pain will be assessed at 5, 30, 45, and 90 minutes.

Primary outcomes

  1. Pain Reduction at 30 Minutes (VAS)

    Time frame: 30 minutes after intervention

    Change in pain intensity measured using the Visual Analog Scale (VAS) from baseline (before intervention) to 30 minutes after treatment. A decrease of ≥2 points on the VAS is considered effective analgesia.

Secondary outcomes

  1. Pain Reduction at Other Time Points (VAS)

    Time frame: 5, 45, and 90 minutes after intervention

    Proportion of participants requiring additional pain medication during the 90-minute observation period after the assigned intervention.

  2. Need for Rescue Analgesics

    Time frame: 5, 30, 45, and 90 minutes after intervention

    Proportion of participants requiring additional pain medication during the 5, 30, 45, and 90 minutes observation period after the assigned intervention.

  3. Patient Satisfaction

    Time frame: 90 minutes after intervention

    Patient-reported satisfaction with pain management, measured on a 5-point Likert scale at the end of observation (90 minutes).

  4. Adverse Events

    Time frame: 5, 30, 45, and 90 minutes after intervention

    All treatment-related adverse events, including injection site pain, nausea, hypotension, or other complications, monitored at 5, 30, 45, and 90 minutes post-intervention.

Other outcomes

  1. Comparison of Analgesic Effect: Single vs Four ISWI

    Time frame: 5, 30, 45, and 90 minutes after intervention

    Change in pain intensity (VAS) at 5, 30, 45, and 90 minutes comparing participants receiving a single intradermal sterile water injection (0.5 ml) versus four injections (0.25 ml each, total 1 ml). This assesses whether multiple injections provide faster or greater pain relief than a single injection.

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

Intradermal Sterile Water Injection Versus Intravenous Morphine for Renal Colic: A Randomized Controlled Trial

Acronym: ISWI-Morph

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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