The Effects of Oral Gabapentin Premedication on Postoperative Nausea and Vomiting and Early Postoperative Recovery Profile in Pediatric Patients Undergoing Adenotonsillectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Incidence of PONV
研究概览
简要总结
The frequent incidence of postoperative vomiting and severe pain in children undergoing adenotonsillectomy, may delay postoperative oral intake and increase the risk of dehydration. Postoperative nausea and vomiting (PONV) is of multi-factorial origin in this group of patients, with a reported incidence ranging from 23% to 73%.
There is growing evidence that the perioperative administration of gabapentinin in adults is beneficial for preoperative anxiolysis, postoperative analgesia, reduction of postoperative nausea and vomiting, and delirium.
Only few studies in literature explored the analgesic effects of preoperative gabapentin as premedication in pediatric population. However, the antiemetic effect of gabapentin in pediatric patients was not systematically investigated before.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged (3-12)
- •ASA physical status I or II
- •Scheduled for adenotonsillectomy surgery in Abu Elrish Al-Mounira Hospital
排除标准
- •Patients who have active infection
- •Obstructive sleep apnea
- •Cognitive impairment
- •Abnormal bleeding profile
- •Renal or hepatic dysfunction
- •History of allergic reaction to study medications or chronic use of anti-consultants will be excluded.
研究组 & 干预措施
Group C
Patients in this group will receive 0.3 ml/kg of a placebo solution identical in taste, shape and color to the study medication two hours before the induction of anesthesia.
干预措施: placebo (Drug)
Group GAB
Patients in this group will receive 0.3 ml/kg (16 mg/kg) oral gabapentin solution (Neurontin 50 mg/ml, Pfizer Pharmaceutical) as premedication two hours before the induction of anesthesia
干预措施: Gabapentin as premedication (Drug)
结局指标
主要结局
Incidence of PONV
时间窗: over the first postoperative 6 hours
The number of patient complaints of nausea and or vomiting will be recorded in the first 6 hours postoperatively
次要结局
- Time to first request of postoperative rescue analgesics.(over the first postoperative 6 hours)
- Duration of recovery(up to 60 minutes after the end of surgery.)
- Postoperative analgesic consumption(over the first postoperative 6 hours)
- Objective pain scale (OPS)(over the first postoperative 6 hours)
- Pediatric Anesthesia Behavior score (PAB)(within10 minutes before the child falls asleep.)
- Incidence and severity of postoperative delirium(up to 60 minutes after the end of the operation.)
研究者
heba mohamed nassar
lecturer of anesthesia
Cairo University