The Use of Ketamine as Rescue Analgesia in the Recovery Room Following Opioid Administration. A Double-blind Randomised Trial in Postoperative Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain scores at rest in recovery and at four hours postoperatively
研究概览
简要总结
This clinical trial will determine if postoperative patients who have postoperative pain, which has been refractory to morphine administration, will have improved pain relief following a bolus administration of ketamine as compared with an ongoing morphine dosing regimen
详细描述
Some patients require large doses of opioids to control postoperative pain, which can result in a prolonged period of poor pain control, and potentially increased side effects associated with large morphine doses. This may be due to insufficient morphine dose to that individual or acute tolerance ( 1 ). Ketamine is not just an anaesthetic agent but at lower doses is known to provide efficacious analgesia ( 2, 3 ). Ketamine has been shown to have a marked analgesic effect on high intensity nociceptive stimuli ( 4 ) as exhibited in postoperative pain. When given for opioid analgesia resistant cancer pain in bolus doses at two different concentrations it has been shown to be effective and have a morphine-sparing effect, without undue complications ( 5 ).
Ketamine has been suggested to work pre-emptively and also by many other routes other than intravenously ( 6 - 9 ) .
Previous studies have compared morphine with morphine and ketamine administered as PCA or intramuscularly ( 10 - 12 ) in postoperative patients with varying effects. Javery et al. ( 11 ) showed that pain scores were lower in patients who received ketamine but Reeves et al. in a later but similar study showed no significant difference ( 13 ).
The authors have noted that in the postoperative situation with morphine resistant pain, a bolus dose of ketamine not only leads to a marked decline in pain but it also remains efficacious for several hours. This prolonged effect was also noted in opioid resistant cancer pain ( 5 ). This indeed may have relevance to the prevention of onset of chronic post surgical pain ( 14 ) and earlier discharge from the Post Anaesthetic Care Unit.
Morphine and ketamine are not without side effects. Respiratory depression, nausea, vomiting and vivid dreams, being well documented will hence be a secondary endpoint. A quality of recovery score will also be measured ( 15 ) and four hours postoperatively.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Those patients requiring the routine pain protocol to be implemented as used in the Post Anaesthetic Care Unit who need more than two doses of morphine (and having received intraoperative morphine).
排除标准
- •Exclusion Criteria
- •Known allergy to morphine or ketamine.
- •Past history of major psychiatric disturbance or currently taking psychiatric medication/s.
- •Chronic morphine usage.
- •Chronic pain syndrome or chronic painful medical condition.
- •Unable to obtain a reliable pain score in recovery due to language barriers or residual anaesthesia.
- •Known pregnancy.
- •Cases where primary anaesthetist prefers alternate therapy.
- •Aged less than 18 years.
- •Weight less than 50 kilograms or greater than 100 kilograms.
- •Use of ketamine intraoperatively.
- •Use of major regional block.
结局指标
主要结局
Pain scores at rest in recovery and at four hours postoperatively
次要结局
- PONV scores - Recovery Room and four hours.
- Morphine protocol consumption.
- Sedation scores - Recovery Room and four hours.
- Frequency of antiemetic administration - Recovery Room and up to four hours.
- Quality of recovery score preoperatively and at four hours.
- Adverse events (vivid dreams, nausea, hallucinations, respiratory depression, pruritus) - Recovery Room and at four hours.
- Time to discharge from the recovery room.