Phase III Clinical Trial Studying Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Degree of pain measured by the EVENDOL score
研究概览
简要总结
The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen.
详细描述
Long-bone fractures are a very common complain for visits in paediatric emergency departments. Since these fractures are often very painful, morphine is considered the cornerstone treatment in case of severe pain. Very few data are available concerning the assessment of analgesic treatment in this condition. In our previous study, less than 50% of patients with a limb fracture had a Visual Analog Scale (VAS) ≤ 30 mm after morphine administration. Thus, one study make the hypothesis that the use of a combination of morphine and/or paracetamol and/or NSAID could be an effective and safe option for the treatment of pain due to long bone fractures. We undertake to compare different combinations of paracetamol and ibuprofen with morphine to determine the efficacy and safety of these strategies in emergency department paediatric patients with acute traumatic limb pain.
The main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen.
Second objectives are
- to compare the long term analgesic efficacy of 4 analgesic regimens a)ibuprofen/morphine, b)paracetamol/morphine, c)ibuprofen/paracetamol/morphine and d)morphine for long bone fracture management in the paediatric emergency department.
- To assess the tolerance of these 4 regimens.
The study is considered as a success if children 2-6 years (6 years included) have a pain score Evendol < 5 and children 7-17 years (17 years included) have a pain score assessed by Visual Analog Scale (VAS) ≤ 30 without additional analgesic treatment 30 minutes after drug administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •children aged 2 through 17 years (17 years included)
- •suspected fracture of a long bone requiring morphine analgesia (VAS ≥ 60/100 or Evendol ≥ 7/15 at the arrival at emergency department)
- •within the first 12 hours after the injury
- •at least one signed parental informed consent
- •affiliated to health insurance
排除标准
- •analgesic treatment within the 6 hours before inclusion
- •contraindication to one of the experimental drug: Paracetamol or Ibuprofen
- •contraindication to Morphine
- •cognitive impairment
- •multiple injuries
- •resuscitation manœuvres
- •suspected femur fracture
- •open fracture
- •pregnant women in the third trimester
研究组 & 干预措施
Ibuprofen+placebo of paracetamol
Patients will receive in addition to morphine (usual care) ibuprofen and placebo of paracetamol
干预措施: Ibuprofen (Drug)
Ibuprofen+placebo of paracetamol
Patients will receive in addition to morphine (usual care) ibuprofen and placebo of paracetamol
干预措施: Placebo (Drug)
Paracetamol + placebo of ibuprofen
Patients will receive in addition to morphine (usual care) paracetamol and placebo of ibuprofen
干预措施: Paracetamol (Drug)
Paracetamol + placebo of ibuprofen
Patients will receive in addition to morphine (usual care) paracetamol and placebo of ibuprofen
干预措施: Placebo (Drug)
Paracetamol + ibuprofen
Patients will receive in addition to morphine (usual care) paracetamol and ibuprofen
干预措施: paracetamol + ibuprofen (Drug)
Placebo of paracetamol + placebo of ibuprofen
Patients will receive morphine alone(usual care).
干预措施: Placebo (Drug)
结局指标
主要结局
Degree of pain measured by the EVENDOL score
时间窗: 30 minutes
To evaluate the degree of pain for children between 2 years and 6 years included : Evendol scale is a validated pain scale for use in the accident and emergency departments on children under 7 years old. Success: children 2-6 years (6 years included) with a pain score Evendol \< 5 without additional analgesic treatment at 30 minutes after drug administration (DA)
Degree of pain measured by the Visual Analog Scale
时间窗: 30 minutes
To evaluate the degree of pain for children between 7 years and 17 years included. Patients will be asked to rate their pain severity on a validated 100 mm horizontal or vertical visual analog scale (VAS) marked "no pain" and "most severe pain" at the low and high ends respectively. A standardized explanation will be given to participating children. Success: children 7-17 years with pain score assessed by Visual Analog Scale (VAS) ≤ 30, without additional analgesic treatment at 30 minutes after drug administration (DA)
次要结局
- Tolerance of morphine(120 minutes)
- Degree of pain measured by the EVENDOL score(120 minutes)
- Degree of pain measured by the Visual Analog Scale(120 minutes)
- Tolerance of ibuprofen(120 minutes)
- Tolerance of paracetamol(120 minutes)