A Randomized Blinded Comparison of Acetaminophen With Codeine and Ibuprofen for Treatment of Acute Pain in Children With Extremity Injuries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in color analog scale pain score
研究概览
简要总结
We compared the pain relief of acetaminophen with codeine versus ibuprofen for children ages 5-18 years who came to the Pediatric Emergency Department with injuries to their arms or legs.
详细描述
We conducted a randomized, double-blinded equivalence trial. Pediatric Emergency Department patients 5-18 years of age with acute extremity pain received acetaminophen-codeine (1 mg/kg as codeine) or ibuprofen (10 mg/kg). They provided Color Analog Scale pain scores at baseline and at 20, 40, and 60 minutes after medication administration. The primary outcome measured was the difference in changes in pain score at 40 minutes, compared against a previously described minimal clinically significant change in pain score of 2 cm. Additional outcomes included need for rescue medication and adverse effects.
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
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •5 to 18 years of age
- •Spoke English as a primary language
- •Complained of an extremity injury with tenderness to palpation from the clavicle or femoral neck to the distal phalanges
- •Scored 5 or greater on a 10-point ordinal or Varni-Ryan pain scale administered at triage
排除标准
- •Allergy or prior adverse reaction to acetaminophen, codeine or ibuprofen;
- •Administration of any analgesic within 6 hours of presentation;
- •Significant deformity or vascular insufficiency of the extremity requiring immediate treatment as determined by the treating physician;
- •Inability to use the study pain instrument;
- •Any laceration near the suspected injury;
- •Chronic hepatic or renal disease;
- •Pregnancy in the third trimester;
- •Concurrent use of contraindicated medications such as monoamine oxidase inhibitors; or
- •Use of central nervous system depressants such as ethanol, benzodiazepines, barbiturates, antidepressants, or recreational drugs
结局指标
主要结局
Change in color analog scale pain score
时间窗: 40 minutes
次要结局
- adverse reaction(during ED stay)
- need for rescue medication(during ED stay)
- Change in pain score(20 and 60 minutes)