Adjunctive Oral Analgesia for Laceration Repair: Assessing Pain in a Pediatric Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pain scores
研究概览
简要总结
Background Approximately 30 million children are treated in emergency departments each year in the United States, of which two to three million are children presenting with lacerations. Topical numbing medication is the standard of care in children with regard to pain control during laceration repair. While topical numbing medications are effective, children often require further pain control during laceration repair in the form of an injected numbing medication, which in itself is painful. No evidence currently exists regarding the concurrent use of oral pain medications to combat laceration procedural pain.
Research Question Does the addition of ibuprofen or oxycodone to lidocaine, epinephrine, and tetracaine (LET) topical anesthetic provide more effective pain control than LET alone during laceration repair?
Design This is a double-blinded, randomized-controlled study.
Methods Subjects in all three groups will receive topical anesthetic. In addition to topical anesthetic, two groups of children will receive either of two oral analgesics, ibuprofen or oxycodone, while the third group will receive a placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking patients
- •Patients 4 years of age up to 10 years of age
- •Patients seen in the ED needing simple facial laceration repair
- •Patients with no chronic medical problems
排除标准
- •Any patient who's parent or primary caretaker refuses consent
- •Any patient who's parent or primary caretaker needs an interpreter
- •Any child with complex laceration(s) or bites
- •Any child who has received pain medication at home in response to the facial laceration.
- •Children needing procedural sedation
- •Children with a known allergy to lidocaine, epinephrine, tetracaine, ibuprofen, or oxycodone
- •Patients with known or pre-existing medical conditions where the study protocol cannot be used
- •This includes any patient with a medical condition that prevents appropriate use of the pain scale
- •It also includes patients with medical conditions that warrant the use of chronic medications
研究组 & 干预措施
Ibuprofen
Subjects will receive topical LET and oral ibuprofen.
干预措施: Ibuprofen (Drug)
Oxycodone
Subjects will receive topical LET and oral oxycodone.
干预措施: Oxycodone (Drug)
Placebo
Subjects will receive topical LET and oral placebo.
干预措施: Placebo (Other)
结局指标
主要结局
Pain scores
时间窗: At Triage, after first suture, and the worst during the procedure
The use of adjunctive oral analgesics for facial/scalp laceration repair decrease pain scores more effectively than LET alone.
次要结局
未报告次要终点
研究者
Heidi Vander Velden
Senior Clinical Research Coordinator
Children's Hospitals and Clinics of Minnesota