Effect of Preoperative Oral Paracetamol Loading Dose Versus Standard Dose on Postoperative Opioid Consumption in Pediatric Tonsillectomy With Multimodal Analgesia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Total postoperative opioid consumption
研究概览
简要总结
This randomized clinical trial compares two different preoperative doses of oral paracetamol (acetaminophen) in children undergoing elective tonsillectomy. The aim is to determine whether a higher loading dose (30 mg/kg) decreases the need for opioid rescue medication after surgery compared with the standard dose (15 mg/kg), when used as part of a multimodal pain management approach. Children aged 3 to 15 years will be randomly assigned to receive either 30 mg/kg or 15 mg/kg of oral paracetamol before surgery. All participants will receive the same standard anesthesia and postoperative pain management. The primary outcome is the total amount of rescue opioid (fentanyl) required during the first 12 hours after surgery. Secondary outcomes include postoperative pain scores and the occurrence of side effects such as nausea and vomiting. This study seeks to determine whether a higher initial dose of paracetamol offers additional clinical benefits in pediatric tonsillectomy with multimodal analgesia.
详细描述
Tonsillectomy is one of the most commonly performed surgical procedures in children, yet it is often associated with significant postoperative pain. Effective pain management is critical to minimizing complications, and a multimodal approach to analgesia is recommended to reduce opioid consumption while providing effective pain relief. Paracetamol is a widely used and safe analgesic component within these multimodal regimens.
While previous studies indicate that an oral paracetamol loading dose of 30 mg/kg effectively reduces fever and provides consistent serum levels, there remains a limited direct comparison of clinical outcomes between an oral preoperative loading dose and a standard dose within preemptive standardized multimodal analgesia protocols for pediatric tonsillectomy. This randomized controlled trial aims to evaluate whether an oral paracetamol loading dose yields a superior opioid-sparing effect compared to a standard dose in this patient population.
A total of 54 pediatric patients, aged 3 to 15 years with ASA physical status I-III, scheduled for elective tonsillectomy (with or without adenoidectomy) will be enrolled. Participants will be randomized in a 1:1 ratio into two groups:
Group L (Loading Dose): Will receive a preoperative oral paracetamol dose of 30 mg/kg (adjusted body weight, maximum 1000 mg) 30-60 minutes before anesthesia induction.
Group C (Standard Dose): Will receive a preoperative oral paracetamol dose of 15 mg/kg (maximum 1000 mg) 30-60 minutes before anesthesia induction.
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
- 3 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3 to 15 years
- •ASA physical status I-III
- •Scheduled for elective tonsillectomy with or without adenoidectomy
排除标准
- •Known allergy or contraindication to paracetamol or any agents in the study protocol
- •Chronic opioid use
研究组 & 干预措施
High-dose oral paracetamol (30 mg/kg)
Participants receive oral paracetamol 30 mg/kg approximately 30-60 minutes before surgery.
干预措施: Paracetamol (acetaminophen) (Drug)
Standard-dose oral paracetamol (15 mg/kg)
Participants receive oral paracetamol 15 mg/kg approximately 30-60 minutes before surgery.
干预措施: Paracetamol (acetaminophen) (Drug)
结局指标
主要结局
Total postoperative opioid consumption
时间窗: 0-12 hours after surgery
Total postoperative opioid consumption (expressed as cumulative IV fentanyl dose in mcg/kg) was administered.
次要结局
未报告次要终点
研究者
Waranya Lertpaitoonpan
Faculty of Medicine, Thammasat University
Thammasat University