NCT00200564Unknown4 期
Ketamine and Postoperative Analgesia in Children
适应症
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Area under the curve of pain scores (CHEOPS) measured
研究概览
简要总结
The benefit of small doses of ketamine has been demonstrated for postoperative analgesia in adults but remains unproved in children. The investigators' purpose is to evaluate the effects of continuous intravenous small doses of ketamine versus placebo to improve the quality of postoperative analgesia in children (6 months to 6 years of age). Caudal anesthesia is performed for intraoperative analgesia and all children receive paracetamol, a non-steroidal anti-inflammatory and continuous intravenous nalbuphine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 6 months to 6 years of age
- •American Society of Anesthesiologists (ASA) I or II
- •Undergoing elective surgery with intraoperative caudal analgesia
排除标准
- •ASA III or IV
- •Contraindication to caudal anesthesia
- •Allergy to drugs used in the study
- •Failure in caudal puncture
- •Administration of morphine derivative
结局指标
主要结局
Area under the curve of pain scores (CHEOPS) measured
时间窗: every 2 hours during the first 24 hours after eyes open
次要结局
- Evaluation by the parents and nurses of the quality of analgesia with a visual analogue scale graded from 0 to 10(at the 24th hour)
- Number of painful episodes requiring additional boluses of nalbuphine
- Number of children requiring morphine after inefficiency of additional boluses of nalbuphine
- Percentage of children with side effects related to injection of ketamine
- Time to complete feeding
- Percentage of children with nausea or vomiting
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Ketamine in Post-operative Dental Pain and RecoveryPost-operative PainNCT02021240The University of Hong Kong150
招募中
不适用
Does the sedative drug ketamine play a role in pain relief following wisdom teeth extractions?Wisdom teeth extractionsOral HealthISRCTN13624724ova Scotia Health Authority Research Ethics Board128
已完成
4 期
Ketamine Infusion for Pediatric Patients With Obstructive Sleep Apnea Syndrome (OSAS) After TonsillectomyObstructive Sleep Apnea SyndromeNCT02425202University of Manitoba36
招募中
不适用
Ketamine Infusion as a Method of Cerebral Protection in ChildrenBrain InjuriesNCT06525584Kemerovo State Medical University196
已完成
不适用
Low Dose Ketamine Infusion for Postoperative Analgesia After Total Knee ArthroplastyPostoperative PainNCT04085588Mustafa Kemal University75