Intravenous Treatment With Non Steroidal Anti Inflammatory Drugs (NSAID) Versus Nebulized Morphine (NM) Analgesia for First-line Renal Colic: Randomized Controlled Double-blind Single-center Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- efficacity: VAS pain reduction
研究概览
简要总结
The aim of the investigators study was to evaluate the feasibility, efficacy and safety of nebulized morphine compared with non-steroidal anti-inflammatory (NSAI)intravenously in the management of renal colic.
Determine the need for systematic outpatient prescription of NSAI.
详细描述
Renal colic are a frequent cause of consultation in the emergency departement (ED).
They count for approximatively 20% of patients presenting to the ED with severe acute onset abdominal pain.
For acute treatment of renal colics (RC), guidelines recommend the use of intravenous (IV) non-steroidal anti-inflammatory (NSAI) drugs in association with antalgics like Paracetamol or Morphine.
But the NSAID present many inconvenient and cannot be used in some type of patients; that's why the investigators investigated the use of other drugs, such as nebulised morphine, in the ED treatment of renal colics.
the NM has the adequacy of being quickest, more practical to use and more tolerated than the IV NSAID.
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 16 years old
- •Consenting to participate in the study
- •Diagnosis of renal colic matching flank pain / lumbar fossa sided with dipstick and / or imaging confirmed the diagnosis
- •VAS> 50% at consultation
排除标准
- •Inability to assess pain VAS;
- •Pregnant or lactating woman;
- •Recognized renal disease (glomerular filtration rate <60ml/kg/1.73m2);
- •Known hepatic insufficiency;
- •Known or suspected allergy to NSAIDs, morphine
- •Peptic ulcer known;
研究组 & 干预措施
Intravenous NSAI
patients received 100 mg of ketoprofen (NSAID) by IV root and in parallel 3 nebulisation of serum saline (SS) over 30 minutes.
干预措施: IV NSAI (Drug)
Intravenous NSAI
patients received 100 mg of ketoprofen (NSAID) by IV root and in parallel 3 nebulisation of serum saline (SS) over 30 minutes.
干预措施: Nebulised Serum Saline (Drug)
Nebulised Morphine
patients received 3 nebulisation of morphine (5 mg each) and in parallel 50 ml of SS by IV root over 30 minutes.
干预措施: NM (Drug)
Nebulised Morphine
patients received 3 nebulisation of morphine (5 mg each) and in parallel 50 ml of SS by IV root over 30 minutes.
干预措施: IV Serum Saline (Drug)
结局指标
主要结局
efficacity: VAS pain reduction
时间窗: 5, 15, 30, 45 and 60 minutes
The effectiveness of treatment is defined by a decrease in the intensity of pain corresponding to a decrease of the VAS above 50% at 60 minutes compared to baseline.
次要结局
- feasibility of the study: number of patients accepting the adhesion to protocol(at base line and at 60 minutes)
- safety: side effects of treatment(5, 15, 30, 45 and 60 minutes)
研究者
Pr. Semir Nouira
Clinical Professor
University of Monastir