Intradermal Sterile Water Injection Versus Intravenous Morphine for Renal Colic: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pain Reduction at 30 Minutes (VAS)
研究概览
简要总结
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:
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Single Intradermal Sterile Water Injection (1 ISWI)
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.
干预措施: Single Intradermal Sterile Water Injection (Procedure)
Multiple Intradermal Sterile Water Injections (4 ISWI)
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.
干预措施: Multiple Intradermal Sterile Water Injections (Procedure)
Intravenous Morphine
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.
干预措施: Intravenous Morphine (Drug)
结局指标
主要结局
Pain Reduction at 30 Minutes (VAS)
时间窗: 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.
次要结局
- 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)
研究者
Sami Chebbi
Dr
University Tunis El Manar