Effectiveness Of Intravenous Vs Rectal Acetaminophen For Pain Management In Post Operative Neonates; A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- change in pain score
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of intravenous (IV) versus rectal acetaminophen for postoperative pain management in neonates. The study includes postoperative term neonates who require analgesia for at least 12 hours. The main questions the study seeks to answer are:
Does IV acetaminophen provide better pain relief compared to rectal administration in neonates? What is the time to rescue analgesia and the efficacy of pain score reduction between these two routes? The study compares 32 neonates receiving IV acetaminophen to 32 neonates administered rectal acetaminophen. Both routes are administered at equivalent bioavailable doses to ensure a fair comparison.
详细描述
This randomized controlled trial investigates the comparative effectiveness of intravenous (IV) versus rectal administration of acetaminophen for managing postoperative pain in neonates. Neonates, due to their limited physiological reserves and underdeveloped metabolic systems, require precise pain management strategies to prevent potential developmental delays or adverse effects. Acetaminophen, a commonly used analgesic in neonatal care, is metabolized primarily by the liver and excreted via the kidneys. However, its pharmacokinetics vary significantly based on the route of administration, making it important to evaluate which method offers more reliable pain relief.
The study includes 64 term neonates who underwent surgery and are expected to require pain relief for at least 12 hours. Preterm and preoperative neonates are excluded. The neonates were randomized into two groups: one receiving acetaminophen intravenously (15 mg/kg) and the other rectally (40 mg/kg), ensuring similar concentrations at the effect site.
Key variables include rescue analgesia requirements, time to rescue analgesia, and changes in pain scores. Pain relief efficacy is measured by pain score changes, and any need for additional analgesia is recorded.
This study will provide valuable insights into the optimal route for administering acetaminophen in neonates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
The primary investigator collects and analyzes the data using self-designed questionnaires. Typically, in such studies, the intervention (route of acetaminophen) would be known to the healthcare providers administering. Therefore, masking of the participants and providers might not be feasible.
入排标准
- 年龄范围
- 1 Hour 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All post-operative neonates requiring acetaminiphen as analgesia.
排除标准
- •All neonates requiring any other kind of Pain relief medication (Nerve block or local analgesia)
- •All neonates in neonatal ICU
- •All neonates with central venous line in place
- •All neonates that are on ventilatory support
研究组 & 干预措施
Per-rectal group
These neonates received Acetaminophen per rectally at dose of 40 mg/kg.
干预措施: Acetaminophen Suppositories (Drug)
Intra-vanous group
These neonates received intravenous Acetaminophen at dose of 15 mg/kg.
干预措施: Acetaminophen Injection (Drug)
结局指标
主要结局
change in pain score
时间窗: 0 to 6 hours
"Bernese Pain Scale for Neonates" will be used consisting of total score of 27
Time for rescue analgesia
时间窗: 0 to 6 hours
time will be measured and compared
次要结局
未报告次要终点
研究者
Hasnain Aslam
Principal Investigator
Rawalpindi Medical College