Randomized Control Trial of Oral Narcotic Medication for Pain and Anxiety Management During Laceration Repair in the Pediatric Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group
研究概览
简要总结
The purpose of this study is:
- To determine whether oral narcotic medication versus placebo improves the pain and anxiety scores for pediatric patients requiring laceration repair in the pediatric emergency department and receiving the standard of care with lidocaine treatment
- To evaluate for a statistical difference in pain scores in children during laceration repair
- To evaluate for a statistical difference in State-Trait Anxiety Inventory for Children (STAIC) scores during laceration repair
详细描述
A prospective, double-blind, placebo-controlled, randomized clinical trial in a tertiary care pediatric emergency department with an annual census of 80,000 visits per year. Patients will be randomized by a randomization table with block randomization in the pharmacy to the oral narcotic or placebo group, and the pharmacist will be the only person aware of the randomization status of the patient. Allocation concealment will be ensured by opaque, sealed envelopes kept in the Emergency Department Pharmacy. Guardians of patients age 2 to 17 years of age will be consented for enrollment.
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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2 to 17 years
- •Laceration of the skin and/or subcutaneous tissue requiring sutures
- •American Society of Anesthesiologists (ASA) score of I or II
排除标准
- •Major injuries in addition to laceration (suspected fracture, intracranial, intrathoracic, or intraabdominal bleeding or organ injury)
- •Abnormal neurologic examination (such as head injury)
- •Severe congenital heart disease
- •Pregnancy
- •Known opiate or acetaminophen allergy
- •Require conscious sedation
- •Have had narcotic or acetaminophen administration within 4 previous hours
研究组 & 干预措施
Hydrocodone/acetaminophen
Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone.
干预措施: hydrocodone/acetaminophen (Drug)
Sugar water
Placebo
干预措施: Sugar water (Drug)
结局指标
主要结局
Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group
时间窗: 5 minutes
Children's Hospital of Eastern Ontario Pain Scale, for children 2-7 years. This score ranks 6 categories: Cry, Facial expression, Verbal Response, Torso movement, Touch, and Leg movement. The scale varies by each category from 0-2 or 1-2 or 1-3; such that a minimum score is 4 (no pain) and a maximum score is 13 signifying greatest pain. This results in a 10 point scale of possible results, and is rated by an objective observer; the child life specialist at the bedside during the laceration repair. If the procedure was completed, there were no scores recorded at that time point.
次要结局
- Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale(1 hour approximately (survey was given pre and post procedure so from 15 minutes to 1 hour after initial survey (or 5 minutes to 45 minutes after the procedure).)
- Visual Analog Scale (VAS) Pain Score for Children > 7 Years.(30 minutes)
研究者
Corrie Chumpitazi
Assistant Professor
Baylor College of Medicine