Percutaneous Pin Removal in the Outpatient Clinic - do Children Require Analgesia? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Pain Score (0 -10)
研究概览
简要总结
This is a simple randomised clinical trial to study if non-narcotic analgesia reduces the pain score and pulse rate of children who undergo removal of percutaneous pins in the outpatient clinic.
Inclusion criteria:
- 5-12 years of age
- 2 or 3 percutaneous pins in either elbow
Exclusion criteria:
- documented or suspected allergies to acetaminophen, ibuprofen
Patients enrolled in the study are instructed not take additional analgesia prior to the clinic visit (risk of overdosage explained). This is verified by clinic nurses conducting the trial.
At the clinic visit, they are randomized into one of three groups
- acetaminophen; 2. ibuprofen; or 3. Vitamin C (Placebo).
They are served the 'medication' (weight-appropriate dose) and the pins are removed in the clinic an hour later.
Pain score (Wong-Baker scale) and pulse rate are measured before pin removal, immediately following pin removal, and 10 minutes after pin removal.
The study hypothesis is that non-narcotic analgesia (such as acetaminophen and ibuprofen) do not decrease pain score and pulse rate associated with the pin removal procedure.
详细描述
See Brief Summary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 5-12 inclusive
- •2 or 3 percutaneous pins in either elbow
排除标准
- •documented or suspected allergies to acetaminophen or ibuprofen
研究组 & 干预措施
Acetaminophen
Acetaminophen was administered 1 hour prior to pin removal (weight dependent dose)
干预措施: Acetaminophen (Drug)
Ibuprofen
Ibuprofen was administered 1 hour prior to pin removal (weight dependent dose)
干预措施: Ibuprofen (Drug)
Vitamin C (Placebo)
Vitamin C was administered 1 hour prior to pin removal (weight dependent dose)
干预措施: Vitamin C (Other)
结局指标
主要结局
Pain Score (0 -10)
时间窗: 10 minutes after pin removal
Pain score is measured using the Wong-Baker Scale
次要结局
- Pulse rate(10 minutes after pin removal)
