A Randomized Controlled Trial of Intranasal Fentanyl in Combination With Midazolam Versus Midazolam Alone for Analgesia and Anxiolysis During Pediatric Facial Laceration Repair
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Modified Yale Preoperative Anxiety Score (mYPAS)
研究概览
简要总结
The purpose of the study is to compare the effectiveness of a combination of intranasal fentanyl and intranasal midazolam to intranasal midazolam alone for analgesia and anxiolysis in patients presenting for facial laceration repair in the pediatric emergency department.
详细描述
This study will be a single blind (blinded observer) randomized control trial to evaluate the efficacy of the combination of intranasal fentanyl and intranasal midazolam compared to intranasal midazolam alone for analgesia and anxiolysis during pediatric facial laceration repair.
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)
盲法说明
A non-blinded researcher (physician) will determine the group to which the patient is assigned and order the medication(s) according to the assigned group. A separate blinded researcher (physician) will then perform the laceration repair, mYPAS, and post-procedure evaluations. The non-blinded researcher, nurse, parent, and patient will be advised not to disclose which medication(s) were administered to ensure blinding of the provider performing the laceration repair and assessment.
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Facial laceration requiring repair with sutures
- •English or Spanish-speaking parent/guardian
排除标准
- •Lacerations requiring IV sedation or subspecialist involvement
- •Patient has other injuries requiring medical attention
- •Patient has vital sign instability, per physician discretion
- •Patient has autism spectrum disorder
- •Patient has allergies to either medication
研究组 & 干预措施
Intranasal Midazolam and Intranasal Fentanyl
Study participants assigned to the combination (experimental) group will receive a weight-based dose of intranasal Fentanyl (50mcg/mL concentration at 2mcg/kg up to 100mcg) followed by intranasal Midazolam (5mg/mL concentration at 0.2mg/kg up to 10mg) using a mucosal atomizer device (1mL syringe with an attached atomizer).
干预措施: Intranasal Fentanyl Spray and Intranasal Midazolam Spray (Drug)
Intranasal Midazolam
Study participants assigned to the control (active comparator) group will receive only intranasal Midazolam (5mg/mL concentration at 0.3mg/kg up to 10mg) using a mucosal atomizer device (1mL syringe with an attached atomizer).
干预措施: Intranasal Midazolam Spray (Drug)
结局指标
主要结局
Modified Yale Preoperative Anxiety Score (mYPAS)
时间窗: Pre-procedure
mYPAS score at time of positioning, to be completed by blinded researcher (provider) to assess anxiety level. Scores range from 22.5 to 100, with higher scores indicating greater anxiety.
次要结局
- Provider Satisfaction with Procedural Sedation (Visual Analog Score)(Immediately after the procedure)
- Parent Satisfaction with Anxiolysis (Visual Analog Scale)(Immediately after the procedure)
- Rate of Treatment Failure(Immediately after the procedure)
- Duration of Procedure(Immediately after the procedure)
研究者
Brittany DiFabio
Pediatric Emergency Medicine Fellow Physician
University of Texas at Austin