Systemic Magnesium to Improve Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blinded, Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
This study is a double-blind randomized controlled trial using intravenous magnesium versus placebo to determine if systemic magnesium can decrease postoperative pain in pediatric patients undergoing tonsillectomy.
Participants will be in one of two arms. Those in Arm 1 will receive magnesium (30 mg/kg bolus followed by a 10mg/kg/hr infusion) while those in Arm 2 will receive an equal volume of normal saline bolus followed by infusion (placebo).
The primary objective is to determine if systemic magnesium will decrease postoperative pain in patients undergoing tonsillectomy. The secondary objectives will determine if systemic magnesium administration is associated with a decrease in opioid-related side effects, decrease the incidence of emergence delirium, and improve postoperative functional recovery.
The study hypothesis is that the use of intravenous magnesium will decrease postoperative pain, decrease opioid-related side effects, decrease the incidence of emergence delirium, and improve functional recovery in patients undergoing tonsillectomy.
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
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 4-10 years old undergoing tonsillectomy by a single surgeon and under the care of that participating surgeon
- •American Society of Anesthesiology (ASA) patient classification of I-III
排除标准
- •Physical or developmental delay
- •Psychiatric illness
- •Current use of sedative or anticonvulsant medication
- •Pre-existing renal disease
- •Pre-existing cardiovascular disease
- •Regular use of analgesic medication
- •Having other procedures in addition to tonsillectomy (however, patients undergoing adenoidectomy with their tonsillectomy will be included in the study)
研究组 & 干预措施
Magnesium
Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure.
干预措施: Magnesium (Drug)
Placebo infusion
Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.
干预措施: Normal saline (Drug)
结局指标
主要结局
Postoperative Pain
时间窗: 90 minutes
Postoperative pain will be measured at 15 minute time intervals in the post-anesthesia care unit (PACU). Pain scores will be evaluated using a standardized validated scale (the Faces Pain Scale Revised (FPS-R)). The Faces Pain Scale is a validated, patient reported, 0 (no pain) to 10 (worst pain imaginable) numeric rating scale. Pain scores will be multiplied by the time spent at each pain score for a calculated "Area Under the Curve" value, ranging from 0 to 900, with lower values indicating more favorable and lower pain scores.
次要结局
- Time to PACU Discharge(Approximately 90 minutes)
- Emergence Delirium(5 minutes after awakening in the recovery room)
- Number of Patients With Postoperative Vomiting(90 minutes)
- Parent Satisfaction(7 days)
- Respiratory Depression(90 minutes)
- Postoperative Pain Medication(90 minutes)
- Postoperative Pain at Home(7 days)
研究者
Hubert Benzon
Principal Investigator
Ann & Robert H Lurie Children's Hospital of Chicago