Does Dexamethasone Reduce Postoperative Pain in Pediatric Tonsillectomy Patients?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Incidence of moderate/severe pain(>/= 4 of 10 using the Wong-Baker faces Scale) during recovery room stay
研究概览
简要总结
The investigators will use a prospective randomized, controlled design utilizing a single preoperative dose of oral dexamethasone or placebo to achieve these specific aims:
- Specific Aim 1: To evaluate the potential for a single preoperative dose of oral dexamethasone administered the night before surgery to reduce the incidence and severity of early post tonsillectomy pain (PTP) in children
- Specific Aim 2: To prospectively evaluate differences in early PTP experience between overweight/obese children and their lean peers.
- Specific Aim 3: To determine whether circulating inflammatory markers are strongly linked to PTP severity in children and whether they could be potential contributors to the higher pain experienced by overweight/obese children following Tonsillectomy and or Adenoidectomy.
详细描述
(See brief summary as well)
The study will serve as a vehicle for a three-pronged approach (clinical observation, biological basis and therapeutic intervention) reflects the applicants professional interest in translational pediatric obesity research If the investigators find that BMI-dependent disparity exists in Post Tonsillectomy Pain (PTP) and that preoperative down regulation of inflammatory response with one preoperative dose of corticosteroids reduces PTP, our findings should ultimately lead to improved postoperative pain management of pediatric PTP especially in obese children.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for tonsillectomy and/or adenoidectomy at University of Michigan, C. S. Mott Children's Hospital
排除标准
- •Known hypersensitivity to dexamethasone
- •Developmental delay
- •Taking chronic analgesics
- •Taking chronic systemic steroids
- •Treatment with steroids in last 30 days
- •Cushings or Prader-Willi or Nephrotic Syndromes
- •Diabetes Mellitus
研究组 & 干预措施
Dexamethasone
Liquid or capsule dexamethasone - to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy
干预措施: Dexamethasone (Drug)
Placebo
Placebo liquid or capsule to be taken orally the evening before scheduled tonsillectomy with or without adenoidectomy
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of moderate/severe pain(>/= 4 of 10 using the Wong-Baker faces Scale) during recovery room stay
时间窗: 0-8 hours postoperatively
Subjects will be evaluated in the Post Anesthesia Care Unit (PACU) until discharge home or to the unit.
次要结局
- Bivariate association between BMI (in Kg/m2) and serum values of inflammatory markers (CRP, TNF-alpha and IL-6) will be computed.(0-8 hours postoperatively)
- Proportion of patients requiring analgesic intervention in the PACU will differ by BMI category (normal, overweight and obese).(0-8 hours postoperatively)
研究者
Olubukola Nafiu
Assistant Professor of Anesthesiology, University of Michigan Medical School
University of Michigan