An interventional study of Single Intradermal Sterile Water Injection and Multiple Intradermal Sterile Water Injections in Renal Colic and Urolithiasis, sponsored by University Tunis El Manar. Active, not recruiting at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by University Tunis El Manar · Not applicable, Interventional, and Treatment
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:
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.
79 studies on the registry are indexed under Renal Colic; 10 are open to participants now.
This study's planned enrollment of 150 is above the median of 118 across 60 interventional studies indexed under Renal Colic.
Browse Renal Colic studies →University Tunis El Manar is the lead sponsor of 74 studies on the registry; 12 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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.
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.
Pain Reduction at 30 Minutes (VAS)
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.
Time frame: 30 minutes after intervention
Pain Reduction at Other Time Points (VAS)
Proportion of participants requiring additional pain medication during the 90-minute observation period after the assigned intervention.
Time frame: 5, 45, and 90 minutes after intervention
Need for Rescue Analgesics
Proportion of participants requiring additional pain medication during the 5, 30, 45, and 90 minutes observation period after the assigned intervention.
Time frame: 5, 30, 45, and 90 minutes after intervention
Patient Satisfaction
Patient-reported satisfaction with pain management, measured on a 5-point Likert scale at the end of observation (90 minutes).
Time frame: 90 minutes after intervention
Adverse Events
All treatment-related adverse events, including injection site pain, nausea, hypotension, or other complications, monitored at 5, 30, 45, and 90 minutes post-intervention.
Time frame: 5, 30, 45, and 90 minutes after intervention
Comparison of Analgesic Effect: Single vs Four ISWI
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.
Time frame: 5, 30, 45, and 90 minutes after intervention
Plan to share: Undecided
Started Jan 2026 (actual). Primary completion is estimated for Jun 2026, 5 months after the start.
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This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University Tunis El Manar