Sterile Water Injection vs Morphine for Renal Colic

NCT07378904 | Active Not Recruiting DMC

• 1 other identifier: HTHEC-2026-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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. 1.Single ISWI injection
2. 2.Four ISWI injections
3. 3.Intravenous morphine

Conditions

Renal Colic; Urolithiasis

Keywords

Renal Colic; Urinary Stones; Intradermal Sterile Water Injection; Intravenous Morphine; Pain Management

Outcome Measures

Primary Outcomes (1)

• 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.

  30 minutes after intervention

Secondary Outcomes (4)

• Pain Reduction at Other Time Points (VAS)

  5, 45, and 90 minutes after intervention

• Need for Rescue Analgesics

  5, 30, 45, and 90 minutes after intervention

• Patient Satisfaction

  90 minutes after intervention

• Adverse Events

  5, 30, 45, and 90 minutes after intervention

Other Outcomes (1)

• Comparison of Analgesic Effect: Single vs Four ISWI

  5, 30, 45, and 90 minutes after intervention

Study Arms (3)

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.

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.

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.

Drug: Intravenous Morphine

Interventions

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.

Single Intradermal Sterile Water Injection (1 ISWI)

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.

Intravenous Morphine

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.

Multiple Intradermal Sterile Water Injections (4 ISWI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Habib Thameur Teaching Hospital

Tunis, Tunis Governorate, 1008, Tunisia

Location

Related Publications (4)

• 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.

  PMID: 32571630 RESULT

• Perros 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.

  PMID: 40956348 RESULT

• Aykanat 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.

  PMID: 37823931 RESULT

• Moussa 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.

  PMID: 32444296 RESULT

MeSH Terms

Conditions

Renal Colic; Urolithiasis; Urinary Calculi; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 30, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

TU (1)