跳至主要内容
临床试验/NCT01498796
NCT01498796终止2 期

KITS Study -Ketorolac In Tonsillectomy Surgery: a Double Blinded, Randomized Clinical Trial

University of Alberta1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
121
试验地点
1
主要终点
Pain post-tonsillectomy

研究概览

简要总结

Our group wishes to test the novel hypothesis that intraoperative use of ketorolac in pediatric patients undergoing tonsillectomy reduces post-operative nausea and vomiting, postoperative pain scores, subsequent narcotic use, and length of hospital stay without adversely affecting post-operative bleed risk, when compared to placebo, in a double-blind, randomized controlled trial.

详细描述

Intraoperative analgesia has a tremendous theoretical potential to decrease postoperative pain, and thus narcotic requirement and length of subsequent hospital stay. There is indeed a dearth of evidence with respect to the clinical effectiveness of such analgesia. Tonsillectomy lends itself particularly well to the use of intraoperative analgesia; post-operative pain scores are high, and the majority of recipients are pediatric patients-a population in which minimization of post-operative narcotic use is a priority.

The effectiveness of intraoperative analgesia for the preemptive management of postoperative pain, nausea and vomiting in tonsillectomy remains controversial. Pre-emptive analgesia was first conceptualized in 1983, with Woolf's work on a postulated central component of postinjury pain hypersensitivity. Tissue injury is typified by post-stimulus sensory disturbances that give rise to continuing pain, a hypersensitivity to further noxious stimuli, as well as pain in response to otherwise innocuous stimuli. These features are attributable to both a reduction in the threshold of skin nociceptors, as well as an increase in the excitability of the central nervous system (CNS) to noxious stimuli. Much experimental data has shown pre-injury analgesia as being superior to post-injury analgesia in terms of minimizing subsequent CNS excitability.

Clinically, the effectiveness of such analgesia has shown to be highly variable with respect to anatomical area, surgical type, as well as analgesic used and its route of administration. A Meta-analysis by Cliff et al. reviewed 66 studies with respect to the primary outcomes of pain intensity scores, supplemental analgesic consumption, and time to first analgesic consumption, and demonstrated that preemptive administration of NSAIDs was superior to that of epidural analgesia, local anesthetic wound infiltration, systemic NMDA receptor antagonists, and systemic opiods.

Ketorolac tromethamine (Toradol) is a parenteral, nonsteroidal anti-inflammatory drug that has been used extensively to provide postoperative analgesia. In a prospective, randomized double-blind study of 57 children undergoing outpatient adenotonsillectomy, Keidan et al. found ketorolac to be comparable to fentanyl in terms of both post-operative nausea and vomiting and pain scores. One study showed that intraoperative ketorolac (60 mg IV) with fentanyl (2 micrograms/kg IV), compared to fentanyl and placebo, administered at the induction of anesthesia resulted in significant opioid sparing, decreased pain scores, lower incidence of nausea and vomiting and earlier discharge compared to fentanyl and placebo in patients undergoing diagnostic laparoscopy.

There is a theoretical risk of post-operative bleeding with use of Toradol, on account of its inhibition of platelet aggregation and prolonging of bleeding time. However, in a meta-analysis of 13 trials comprising 955 children undergoing tonsillectomy, Cardwell et al. found that postoperative NSAIDs did not significantly alter number of perioperative bleeding events requiring surgical intervention. At present, it is common practice by some clinicians at the Stollery Children's hospital for pediatric patients who are undergoing standard electrocautery adenotonsillectomy to receive intraoperative ketorolac. Its role in improving post-operative pain and possible risk of increasing post-operative bleeding remains controversial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment

入排标准

年龄范围
3 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients aged 3yrs-15yrs who will undergo tonsillectomy or adeno-tonsillectomy for sleep disordered breathing confirmed by oximetry

排除标准

  • Severe Obstructive Sleep Apnea
  • Co-morbid disease precluding use of NSAIDS or Narcotics
  • Language/developmental/social inability to assess pain scores

研究组 & 干预措施

Ketorolac

Experimental

干预措施: Ketorolac (Drug)

Placebo

Placebo Comparator

干预措施: Normal Saline (Drug)

结局指标

主要结局

Pain post-tonsillectomy

时间窗: post-operative

pain post-tonsillectomy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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