Ibuprofen vs. Codeine. Is One Better for Post-operative Pain Relief Following Reduction of Paediatric Forearm Fractures?
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain Diary
研究概览
简要总结
For simple fractures treated in the emergency department with cast immobilisation only, ibuprofen has been shown to be superior to, or a least or equivalent to codeine with less side effects. These and other studies have commented that their results may not be applicable to children who have fractures that require reduction. There is currently no literature on the management of postoperative pain following reduction of paediatric fractures. The investigators aim therefore is to investigate whether either of the two most commonly prescribed analgesics is superior to the other for postoperative pain management following closed reductions of paediatric forearm fractures. Also, if one agent has more side effects than the other.
详细描述
This will be a prospective randomised controlled trial with the null hypothesis that there is no difference between ibuprofen and codeine in terms of pain relief or side effects.
Following ethics approval (submitted and approved) by the University of Manitoba ethics board a study group of fifty patients (25 in each arm) will be recruited to participate in the study.All patients will complete informed consent following both a verbal and written explanation of the study. Following the closed reduction they will all receive regular acetaminophen; (dose 15mg/kg) and either ibuprofen (10mg/kg) or codeine (1mg/kg) depending upon the group they were randomised to. This will have to be single blinding as the codeine formulation used by the hospital is a clear red liquid (5mg/ml) and the ibuprofen a cloudy colourless liquid (20mg/ml). They will also be given a "rescue" medication to be taken if the caregivers feel that the pain relief is not sufficient 1 hour after the study medication. This rescue medication will be the alternative medication in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All paediatric patients presenting to the section of paediatric orthopaedics requiring a closed reduction of a forearm fraction under either sedation or general anaesthetic.
- •Patients who are able to return to follow up.
排除标准
- •Any children with a history of gastrointestinal bleeding or ulceration, a bleeding disorder, a history of a low platelet count, a history of kidney disease, an uncontrolled chronic disease, or regular use of or allergy to acetaminophen, ibuprofen, or codeine.
- •Children are also ineligible if they or their parents are unable to understand the consent process.
- •Any child requiring anything other than a cast to supplement the stability of the fracture or an open reduction and internal fixation of the fracture.
- •Open fractures.
研究组 & 干预措施
Acetaminophen and Codeine
After their fracture is reduced, these patients will receive acetaminophen (15mg/kg) and codeine (1mg/kg) at regular dosing intervals.
干预措施: Acetaminophen and Codeine (Drug)
Acetaminophen and Ibuprofen
Following reduction of their fracture, these patients will receive acetaminophen (15mg/ml) and ibuprofen (10mg/ml) at regular dosing intervals.
干预措施: Acetaminophen and Ibuprofen (Drug)
结局指标
主要结局
Pain Diary
时间窗: Two Weeks
Caregivers, or the children if old enough, will be asked to keep a pain diary. This will consist of the times the analgesia was taken and a pain score at awakening, at bedtime and before and 1 hour after each dose of medication. Caregivers/children will also be asked to include any side effects noted to medication and whether play, school, sleep, and eating are affected by pain each day. Caregivers will record whether the function was increased, decreased, or unchanged.
次要结局
- Patient Satisfaction(2 weeks)