Ketamine Infusion for Pediatric Patients With Obstructive Sleep Apnea Syndrome After Tonsillectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Measurement of post-operative opioid requirements after tonsillectomy in obstructive sleep apnea (OSA) patients
研究概览
简要总结
The study will evaluate the post-operative morphine-sparing effect, pain reduction, and side effects of a continuous ketamine infusion after tonsillectomy in pediatric patients.
详细描述
Eligible pediatric patients that are undergoing tonsillectomy for sleep-disordered breathing or obstructive sleep apnea AND are to be admitted into a monitored setting will be recruited for this study. They will be randomized into two groups:1) Control group receiving continuous infusion of saline (placebo) and 2) Study group receiving continuous infusion of low-dose ketamine at 0.1 mg/kg/hr. Both patients will receive scheduled oral acetaminophen and rescue intravenous morphine as required. The infusions will be stopped at 0600 the next morning. Morphine requirements, pain scores at selected times, central nervous system side effects, and adverse cardiorespiratory events will be recorded.
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
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients requiring tonsillectomy for diagnosis of sleep disordered breathing/obstructive sleep apnea that will be admitted for overnight cardiorespiratory monitoring, based on positive polysomnography test, positive nocturnal home oximetry, or strong signs/symptoms of OSAS
排除标准
- •Patients with significant developmental delay, abnormal airway anatomy, significant co-morbidities such as cardiac disorders, respiratory disorders, neurological disorders, anad renal disorders.
- •Previous reaction to study medications.
- •Postoperative bleeding within the first 24 hours
- •Refusal to be involved in the study..
研究组 & 干预措施
Ketamine infusion
Ketamine infusion at 0.1 mg/kg/hr up to maximum of 10 mg/hr
干预措施: Ketamine (Drug)
Saline infusion
Saline infusion
干预措施: Saline infusion (Other)
结局指标
主要结局
Measurement of post-operative opioid requirements after tonsillectomy in obstructive sleep apnea (OSA) patients
时间窗: 24 hrs
Influence of low-dose continuous ketamine infusion on post-operative opioid requirements after tonsillectomy in OSA patients.
次要结局
- Documentation of respiratory morbidity after tonsillectomy in OSA patients(24 hrs)