Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Respiratory Depression Following Opioids
研究概览
简要总结
The sole objective in this study is to evaluate if routine amounts of opioids given for tonsillectomy in children have greater amounts of respiratory depression in children with documented obstructive sleep apnea when compared with patients that do not have obstructive sleep apnea
详细描述
Ventilatory suppression in children following opioid administration is of obvious concern, especially following routine surgical procedures (i.e. adenotonsillectomy). It is thought that patients with obstructive sleep apnea (OSA) have increased sensitivity to opioids, and especially in opioid naïve patients. Recent evidence in adults suggests that patients with moderate to severe OSA may not predispose patients to increased opioid sensitivity in the form of respiratory depression when compared with patients that do not have OSA. It is well known that OSA in children is significantly different from OSA in adults (e.g. gender predilection, central vs. peripheral causation). The manifestation and etiologies are very different in pediatric OSA making it a vastly different disease process.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •tonsillectomy or adenotonsillectomy
- •Ages 2 to 8 years
- •Polysomnography with AHI >6 (study group)
- •Polysomnography with AHI =0 or negative OSA 18 questionnaire (control group)
排除标准
- •Ages >8 years
- •Patients requiring pre-medication
- •Parental refusal
- •Opioid allergy/intolerance
- •Patients requiring propofol for intubation
- •Patients with known or suspected difficult airway
- •Obesity with body mass index exceeding 30- (control group only)
- •Known cardiovascular disorders
- •Known pulmonary disorders aside from asthma
- •Patients with chronic oxygen requirement
- •History of Prematurity <35 weeks of gestation
- •No recent URI
- •Personal of family history of malignant hyperthermia
研究组 & 干预措施
Control group; patients without obstructive sleep apnea
Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes
干预措施: Fentanyl (Drug)
Patients with known obstructive sleep apnea
Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes
干预措施: Fentanyl (Drug)
结局指标
主要结局
Respiratory Depression Following Opioids
时间窗: mean percentage of change from baseline in end tidal co2 measured 10 minutes following opioid administration
Identification of respiratory depression following routine fentanyl administration by recording the end-tidal co2 % change from baseline prior to and 10 minutes following fentanyl administration
次要结局
未报告次要终点
研究者
Adam Adler MD, MS, FAAP
Assistant Professor of Anesthesiology
Baylor College of Medicine