Pain Reduction for Limb Injuries in Pediatric Emergency Departments: a Randomised Clinical Trial Comparing Intranasal Fentanyl or Intranasal Ketamine to Oral Morphine
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Degree of pain (M30)
研究概览
简要总结
The purpose of this study is to determine if IN fentanyl (1.5 µg/kg) or IN ketamine (1 mg/kg) is more effective at 30 minutes than oral morphine (0.5 mg/kg) in reduction of moderate and severe pain associated with limb injuries in patients 2-17 years of age presenting to the ED.
详细描述
In children with moderate to severe pain due to musculoskeletal injuries, the first-line analgesic therapy in pediatric emergency departments (ED) is oral or intravenous morphine. Due to the delay or discomfort associated with establishing IV access, oral forms are preferred in French ED. Unfortunately, oral morphine alone or with ibuprofen or paracetamol, none regimen is optimal for relieving pain in children with traumatic limb injuries. However, the use of intranasal course is a safe route that can provide rapid and almost immediate analgesia. Intranasal administration is easy, non-invasive and usually well tolerated by children. In the last years, drugs with analgesic and sedative properties is increasing, particularly on fentanyl, ketamine, which can be also administered by the IN route. There are currently no studies, neither published nor ongoing, which compare IN fentanyl or IN ketamine to a standard oral morphine for children with acute moderate to severe pain with limb injuries presenting to the ED. The main hypothesis is that the efficacy of the analgesia 30 minutes after the administration will be higher with IN Fentanyl or with IN Ketamine, when compared to oral morphine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child aged 2 years to 17 years and 11 months
- •With 10 kg ≤ Weight ≤ 100 kg
- •Presenting to ED with a traumatic pain and suspected fracture(s) based on an acute deformity AND experiencing pain and/or functional impotence in the injured limb(s)
- •Within the first 12 hours after the injury
- •VAS pain score at ED arrival ≥ 60/100 (if child ≥ 7 years) or Evendol pain score at ED arrival ≥ 7/15 (if child < 7 years)
- •Affiliated to health insurance
- •At least one signed parental informed consent
排除标准
- •Received narcotic pain medication prior to arrival
- •Contraindication to morphine, mentioned in SmPC
- •Hypersensitivity to ketamine or fentanyl or to excipients (sodium chloride, sodium hydroxide), or to other opioids.
- •Contraindication to fentanyl or ketamine, mentioned in SmPC
- •Evidence of significant femur, head, chest, abdominal, or spine injury
- •Open fracture
- •Nasal trauma or complete nasal obstruction
- •Active epistaxis
- •Nasal or sinus surgery within 6 months before inclusion
- •History of high blood pressure, known coronary artery disease, congestive heart failure, acute glaucoma, increased intracranial pressure, major psychiatric disorder, hepatocellular insufficiency
- •Active or history of psychiatric disorder
- •Known pregnancy or suspicion of being pregnant
- •Breastfeeding
- •Non-French speaking parent and / or child.
- •Participation to another interventional clinical research
研究组 & 干预措施
Morphine
Oral morphine (0.5mg/kg) and IN placebo
干预措施: Morphine (Drug)
IN Ketamin
placebo of oral morphine and IN ketamine (1 mg/kg)
干预措施: IN ketamine (Drug)
Morphine
Oral morphine (0.5mg/kg) and IN placebo
干预措施: NaCl 0,9 % (Drug)
IN Fentanyl
placebo of oral morphine and IN fentanyl (1.5 µg/kg)
干预措施: IN fentanyl (Drug)
IN Fentanyl
placebo of oral morphine and IN fentanyl (1.5 µg/kg)
干预措施: NaCl 0,9 % (Drug)
IN Ketamin
placebo of oral morphine and IN ketamine (1 mg/kg)
干预措施: NaCl 0,9 % (Drug)
结局指标
主要结局
Degree of pain (M30)
时间窗: 30 minutes
Success: children ≥ 7 years with pain score assessed by VAS ≤ 30, 30 minutes after drugs administration, without rescue analgesia. Visual Analog Scale : 0-100 (no pain- painful)
次要结局
- Degree of pain (M15)(15 minutes)
- Degree of pain (M60)(60 minutes)
- Degree of pain (M90)(90 minutes)
- Reduction in pain (M15)(15 minutes)
- Degree of pain (M120)(120 minutes)
- Reduction in pain (M30)(30 minutes)
- Reduction in pain (M60)(60 minutes)
- Reduction in pain (M120)(120 minutes)
- Reduction in pain (M90)(90 minutes)
- Degree of pain (M30) for comparison ketamine vs fentanyl(30 minutes)
- Level of sedation (M5)(5 minutes)
- Level of sedation (M10)(10 minutes)
- Level of sedation (M90)(90 minutes)
- Level of sedation (M15)(15 minutes)
- Level of sedation (M30)(30 minutes)
- Level of sedation (M60)(60 minutes)
- Level of sedation (M120)(120 minutes)
- Number of participants with Adverse events(From study treatment intake until ED discharge, up to 1 day)
- Score of satisfaction(At ED discharge, up to 1 day)