Oral Morphine Versus Ibuprofen for Post-operative Pain Management in Children: a Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Change in faces pain score pre and post intervention
研究概览
简要总结
Children 5-17 years of age who have undergo orthopedic day surgical procedures for definitive management of fractures, tendon release, etc. will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for 48 hours post-operatively at home. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in significantly lower pain scores on the Faces Pain Scale Revised (FPS-R) compared to ibuprofen. It is hoped that the results of this trial will create a new option for post-operative pain management in children.
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, Investigator)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all children aged 5-17 years who undergo an elective orthopedic or fracture-related surgical procedure at the Children's Hospital in London, Ontario and have a same-day discharge.
排除标准
- •known hypersensitivity to either ibuprofen or morphine
- •chronic users of NSAIDS or opioids
- •cognitive impairment
- •poor English fluency
- •pregnancy
- •acute or chronic renal insufficiency
- •bleeding disorder
- •obstructive sleep apnea
研究组 & 干预措施
ibuprofen
ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 8 doses) from the time the patient is discharged from hospital as deemed by the physician to a maximum of 48 hours.
干预措施: Ibuprofen (Drug)
oral morphine
oral morphine 0.5 mg/kg (max 20 mg) every 6 hours as needed for pain (maximum 8 doses) from the time the patient is discharged from hospital as deemed by the physician to a maximum of 48 hours.
干预措施: oral morphine (Drug)
结局指标
主要结局
Change in faces pain score pre and post intervention
时间窗: 48 hours from the time of discharge from hospital.
次要结局
- Change in faces pain score pre and post intervention(48 hours from the time of discharge from hospital)
- Number of participants requiring acetaminophen for breakthrough pain(48 hours from first dose of intervention)
- Adverse effects(96 hours from first dose of intervention)
- Unscheduled visits to a health care provider for pain(96 hours from first dose of intervention)
研究者
Naveen Poonai
Principal Investigator
Lawson Health Research Institute