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

January 22, 2026 updated by: Sami Chebbi, University Tunis El Manar

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
    • Tunis Governorate
      • Tunis, Tunis Governorate, Tunisia, 1008
        • Habib Thameur Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Intradermal Sterile Water Injection (1 ISWI)
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.
Procedure: Single Intradermal Sterile Water Injection
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.
Experimental: Multiple Intradermal Sterile Water Injections (4 ISWI)
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.
Procedure: Multiple Intradermal Sterile Water Injections
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.
Active Comparator: Intravenous Morphine
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.
Drug: Intravenous Morphine
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5, 45, and 90 minutes after intervention
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.
5, 30, 45, and 90 minutes after intervention
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).
90 minutes after intervention
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.
5, 30, 45, and 90 minutes after intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5, 30, 45, and 90 minutes after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Tunis El Manar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTHEC-2026-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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