Renal Colic, Urolithiasis
Conditions
Keywords
Renal Colic, Urinary Stones, Intradermal Sterile Water Injection, Intravenous Morphine, Pain Management
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. 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.
Interventions
PROCEDURESingle 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.
PROCEDUREMultiple 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.
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.
Sponsors
University Tunis El Manar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction at 30 Minutes (VAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction at Other Time Points (VAS) | 5, 45, and 90 minutes after intervention | Proportion of participants requiring additional pain medication during the 90-minute observation period after the assigned intervention. |
| Need for Rescue Analgesics | 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. |
| Patient Satisfaction | 90 minutes after intervention | Patient-reported satisfaction with pain management, measured on a 5-point Likert scale at the end of observation (90 minutes). |
| Adverse Events | 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. |
Countries
Tunisia
Outcome results
None listed