A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Patient Anxiety at the Time of Separation
研究概览
简要总结
The purpose of this investigator-initiated study is to compare the efficacy of oral midazolam and zolpidem for preoperative sedation, anxiety of patient, and caregiver anxiety at the time of separation, and ease of mask acceptance at induction in children. Subjects will be randomized to receive oral medication midazolam or zolpidem approximately 30 minutes prior to surgery. No placebo will be administered in this study. Subjects will be male and female children between 2 and 9 years of age. In total, subject participation will last approximately the duration of their preoperative, perioperative, and immediate postoperative period. A member of the research team will recruit subjects preoperatively in the operating room holding area prior to surgery. Consent will take place at the time of recruitment in the preoperative holding area following a detailed explanation of the study and medications involved in the study. Participants will be of ASA (American Society of Anesthesiologists) class I-II, undergoing surgical procedures of at least 2 hours duration, and expected to remain inpatient for at least 23 hours postoperatively.
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 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients ages 2-9 years
- •ASA class I-II
- •inpatient surgeries of at least 2 hours duration
- •requiring postoperative admission of at least 23 hours
排除标准
- •Exclusion Criteria:
- •contraindication to preoperative sedation, known allergy or sensitivity to the study medications,
- •those who lack legal representative consent
- •Patients with weights lying below the 5th percentile or above the 95th percentile according to the current published CDC growth chart will also be excluded regardless of existing specific contraindication.
研究组 & 干预措施
zolpidem
zolpidem given orally 0.25mg/kg pre-operatively single dose
干预措施: zolpidem (Drug)
midazolam
midazolam will be given at 0.5mg/kg, pre-operatively single dose
干预措施: Midazolam (Drug)
结局指标
主要结局
Patient Anxiety at the Time of Separation
时间窗: Up to 24 hours including preoperative, preoperative, and postoperative periods.
The primary outcome measure of patient anxiety will be measured using the validated Modified Yale Preoperative Anxiety Score (mYPAS). The mYPAS is the current standard for evaluation of anxiety in children receiving anesthesia for surgical procedures. The modified Yale Preoperative Anxiety scale (m-YPAS) is a structured observational measure of preoperative anxiety in children. It was developed by the study group lead by Kain Z. It consists of assessment of 27 items in 5 domains of behavior indicating anxiety in young children; activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each item is weighted in calculation of the total score that ranges from 22.5 -100. Children with a score above 30 are considered anxious while those with the score of 30 or less were considered not anxious.
次要结局
- Parental/Caregiver Anxiety Assessed Using the Validated State-Trait Anxiety Inventory for Adults (STAI)(Preoperative holding area from the time of informed consent until caregiver/patient separation.)
- Mask Acceptance Score(During induction of general anesthesia.)
- Presence of Emergence Delirium During Recovery(Up to 30 minutes after child's first eye opening in the post-operative period.)
研究者
Davinder Ramsingh, MD
Principal Investigator
Loma Linda University