A Randomized Controlled Trial to Compare Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Number of Patients Requiring Rescue Intravenous Opioid
研究概览
简要总结
A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.
详细描述
This is a randomized clinical trial with masked assessment, comparing recovery indices for patients receiving intermediate acting versus short acting opioid analgesia using hydromorphone or fentanyl as intraoperative analgesics. An otherwise standardized anesthetic and analgesic regimen will be utilized, consistent with routine care at SLCH. Patients will be randomized 1:1 in block sizes of 5 per group. Patients will be randomized to receive either hydromorphone or fentanyl throughout the perioperative period by opening a sealed protocol envelope.
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
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children ages 2 to 15 years old
- •Presenting for tonsillectomy or adenotonsillectomy surgery
- •American Society of Anesthesiologists Physical Status (ASAPS) Classification 1, 2 or 3
- •Provide Informed Consent / Assent (as appropriate)
排除标准
- •Additional Concurrent surgeries, exclusive of myringotomy tubes, minor oral/nasal procedures (e.g. frenulectomy), and endoscopic procedures
- •Revision tonsillectomy or revision adenotonsillectomy surgery
- •Known pregnancy
- •Any condition which would make the participant, in the opinion of the investigator or the attending anesthesiologist caring for the patient, unsuitable for the study.
研究组 & 干预措施
Fentanyl
干预措施: Fentanyl (Drug)
Hydromorphone
干预措施: Hydromorphone (Drug)
结局指标
主要结局
Number of Patients Requiring Rescue Intravenous Opioid
时间窗: up to 6 hours post surgery
Number
次要结局
- Evaluation of Participant's Pain(Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.)
- Evaluation of Participant's SpO2 Saturation(Upon arrival and then every 5 minutes for 15 minutes. Then every 15 minutes until discharged from phase 1 of the PACU.)
- Respiratory and PONV Events at Home(up to 7 days following surgery)
- Respiratory and PONV Events in PACU(up to 6 hours following surgery)