Renal ColicISWI-MorphNCT07378904
Sterile Water Injection vs Morphine for Renal Colic
A study testing Single Intradermal Sterile Water Injection, Multiple Intradermal Sterile Water Injections and Intravenous Morphine in people with Renal Colic and Urolithiasis, run by University Tunis El Manar at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Colic, Urolithiasis
- What is being tested?
- Single Intradermal Sterile Water Injection, Multiple Intradermal Sterile Water Injections and Intravenous Morphine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTunisia
- Study dates
- 20 Jan 2026to 30 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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:
- Single ISWI injection
- Four ISWI injections
- 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.
- Conditions
- Renal Colic, Urolithiasis
- Being tested
- Single Intradermal Sterile Water Injection, Multiple Intradermal Sterile Water Injections, Intravenous Morphine
- Keywords
- Renal Colic, Urinary Stones, Intradermal Sterile Water Injection, Intravenous Morphine, Pain Management
- Medical subject headings
- Renal Colic, Urolithiasis, Urinary Calculi, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Intradermal Sterile Water InjectionProcedure or surgery
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 InjectionsProcedure or surgery
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 MorphineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Intradermal Sterile Water Injection (1 ISWI) | Experimental | 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. Receives: Procedure: Single Intradermal Sterile Water Injection |
| Multiple Intradermal Sterile Water Injections (4 ISWI) | Experimental | 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. Receives: Procedure: Multiple Intradermal Sterile Water Injections |
| Intravenous Morphine | Active comparator | 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. Receives: Drug: Intravenous Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes after intervention
Secondary outcomes (4)
Pain Reduction at Other Time Points (VAS)
Proportion of participants requiring additional pain medication during the 90-minute observation period after the assigned intervention.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 5, 30, 45, and 90 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start20 Jan 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three groups: single intradermal sterile water injection (ISWI), four ISWI injections, or intravenous morphine. Each participant will receive only the assigned intervention, and outcomes (pain reduction, analgesic use, patient satisfaction) will be compared between groups. The study is conducted in a double-blind manner, meaning the emergency physician assessing pain and the epidemiologist performing data analysis are blinded to treatment allocation, while patients are aware of the treatment they receive.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sami Chebbi, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378904
- Sponsor's protocol ID
- HTHEC-2026-02
- Acronym
- ISWI-Morph
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Golcuk Y, Demir A, Yildirim B, Acar E. Intradermal sterile water injection in acute renal colic. Am J Emerg Med. 2021 Feb;40:204. doi: 10.1016/j.ajem.2020.05.060. Epub 2020 May 25. No abstract available.
PubMed 32571630Perros I, Sokhal BS, Swift C, Kitchen M, Mallen C, Somani B. Sterile water injections for analgesia in renal colic: a meta-analysis of level 1 evidence. World J Urol. 2025 Sep 16;43(1):557. doi: 10.1007/s00345-025-05920-x.
PubMed 40956348Aykanat MC, Kilic M, Cimilli Ozturk T, Ustaalioglu I, Ak R. The efficacy of intradermal sterile water application in severe renal colic: a randomised clinical trial. Urolithiasis. 2023 Oct 12;51(1):121. doi: 10.1007/s00240-023-01496-6.
PubMed 37823931Moussa M, Papatsoris AG, Chakra MA. Intradermal sterile water injection versus diclofenac sodium in acute renal colic pain: A randomized controlled trial. Am J Emerg Med. 2021 Jun;44:395-400. doi: 10.1016/j.ajem.2020.04.079. Epub 2020 Apr 29.
PubMed 32444296