Preoperative Gabapentin for Reduction of Post-tonsillectomy Pain in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Total Oral Analgesia Consumption
研究概览
简要总结
The typical post-operative course for children following surgical removal of their tonsils and adenoids can be challenging, especially for pain control. First line medications for pain include intravenous and enteral narcotics, acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) or N-methyl-D-aspartate (NMDA) antagonists but their effects appear to be short-lived. Gabapentin has been shown in adult studies to tone down the body's response to pain and decreases opioid use post-operatively. The purpose of this study is to see if a single preoperative dose will reduce post-operative pain scores and the amount of analgesic used.
详细描述
This is a randomized, double blind, placebo-controlled trial to study the effect of a preoperative oral dose of gabapentin on postoperative analgesic requirements and subjective pain levels in children undergoing tonsillectomy with adenoidectomy. Investigators will also look for a limited set of genotypic variations to explain any difference between individuals or groups in their response to the medication. Additionally, investigators will document potential adverse effects including excessive sedation, respiratory issues, surgical bleeding and emergence agitation/delirium.
Investigators hypothesize that gabapentin will reduce opioid analgesic requirements and pain scores up to 36 hours post adenotonsillectomy without increased adverse effects such as emergence delirium, respiratory complications or bleeding. The clinical effect may depend on the individual's pharmacogenetic profile to look for a specific set of genetic polymorphisms that relate to the metabolism and effect of the study drug, gabapentin, and opioid analgesic pain medications.
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
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for outpatient tonsillectomy and adenoidectomy
- •< 60 Kg, between 5th and 95th percentile for weight
- •ability to self-report pain
- •complete pain diary with assistance from parent or guardian
排除标准
- •require pre-anesthesia medication for anxiety
- •require interpreter for verbal or written communication
- •Obstructive sleep apnea significant enough to not qualify for outpatient surgery per surgeon
- •ongoing oxygen dependence, pulmonary hypertension
- •elevated risk of regurgitation
- •history of seizures
- •currently taking psychoactive medications or having a psychiatric condition requiring medications
- •chronic pain disorders requiring medications
- •renal disease
- •developmental or cognitive disabilities
- •history of adverse reactions to components of liquid gabapentin or placebo
研究组 & 干预措施
Gabapentin
gabapentin, 20 mg/kg, single dose, 60 min prior to surgery
干预措施: Gabapentin (Drug)
liquid placebo
subjects randomized to the liquid placebo arm will receive a single dose elixir of 0.4 mL/kg given 60 min prior to surgery
干预措施: liquid placebo (Drug)
结局指标
主要结局
Total Oral Analgesia Consumption
时间窗: Up to 36 hours
Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively.
次要结局
- Self-report Pain Score at Rest(Up to 36 hours)
- Self-report Pain Score When Swallowing(Up to 36 hours)