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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Alberta.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ban Tsui, University of Alberta
ClinicalTrials.gov Identifier:
NCT01498796
First received: December 21, 2011
Last updated: December 22, 2011
Last verified: December 2011

December 21, 2011
December 22, 2011
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Pain
Same as current
Complete list of historical versions of study NCT01498796 on ClinicalTrials.gov Archive Site
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KITS Study -Ketorolac In Tonsillectomy Surgery: a Double Blinded, Randomized Clinical Trial
KITS Study -Ketorolac In Tonsillectomy Surgery: a Double Blinded, Randomized Clinical Trial

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.

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.

i Woolf CJ: Evidence for a central component of post-injury pain hypersensitivity. Nature 1983; 308: 386-8

ii Coderre TJ, Catz J, Vaccarino AL, Melzack R: Contribution of central neutoplasticity to pathological pain: Review of clinical and experimental evidence. Pain 1993; 52: 259-85

iii Aida S, Baba H, Yamakura T, MD, Taga K, Fukuda S, Shimoji K: The Effectiveness of Preemptive Analgesia Varies According to the Type of Surgery: A Randomized, Double-Blind Study. Anesth Analg 1999;89: 711 ivOng CKS, Lirk P, Seymour RA, Jenkins BJ: The Efficacy of Preemptive Analgesia for Acute Postoperative Pain Management: A Meta-Analysis. Anesth Analg 2005;100:757-773

v Keidan I, Zaslansky R, Eviatar E, Segal S, Sarfaty SM. Intraoperative ketorolac is an effective substitute for fentanyl in children undergoing outpatient adenotonsillectomy.

Paediatric Anaesthesia. 14(4):318-23, 2004 Apr.

vi Green CR, Pandit SK, Levy L, Kothary SP, Tait AR, Schork MA Intraoperative ketorolac has an opioid-sparing effect in women after diagnostic laparoscopy but not after laparoscopic tubal ligation. Anesthesia & Analgesia. 82(4):732-7, 1996 Apr.

vii Cardwell M, Siviter G, Smith A Non-steroidal anti-inflammatory drugs and perioperative bleeding in paediatric tonsillectomy. Cochrane Database of Systematic Reviews. Issue: 2 Article: CD003591, 2005

Interventional
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Recurrent Acute Tonsillitis
  • Drug: Ketorolac
  • Drug: Normal Saline
  • Experimental: Ketorolac
    Intervention: Drug: Ketorolac
  • Placebo Comparator: Placebo
    Intervention: Drug: Normal Saline
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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Inclusion Criteria:

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

Exclusion Criteria:

  • Severe Obstructive Sleep Apnea
  • Co-morbid disease precluding use of NSAIDS or Narcotics
  • Language/developmental/social inability to assess pain scores
Both
3 Years to 15 Years
Not Provided
Canada
 
NCT01498796
Pro00002357
No
Ban Tsui, University of Alberta
University of Alberta
Not Provided
Not Provided
University of Alberta
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP