Sterile Water Injection vs Morphine for Renal Colic

N/AActive Not RecruitingNCT07378904

University Tunis El Manar150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Interventions

Single Intradermal Sterile Water InjectionPROCEDURE

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

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.