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TerminatedNCT01498796KITSUpdated Mar 25, 2020

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

A Phase 2 interventional study of Ketorolac and Normal Saline in Recurrent Acute Tonsillitis, sponsored by University of Alberta. Terminated at 1 site in Canada. Open to participants aged 3 Years to 15 Years. Per ClinicalTrials.gov, last updated 2020-03-25.

Sponsored by University of Alberta · Phase 2, Interventional, and Treatment

Why this study was terminated
PI no longer at institution

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Sep 2009, registered Dec 2011).
Phase
Phase 2
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
3 Years to 15 Years
Sex
All
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Recurrent Acute Tonsillitis

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03

In context

Tonsillitis

103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.

This study's enrollment of 121 is above the median of 100 across 87 interventional studies indexed under Tonsillitis.

Browse Tonsillitis studies →

Lead sponsor

University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Severe Obstructive Sleep Apnea
  • Co-morbid disease precluding use of NSAIDS or Narcotics
  • Language/developmental/social inability to assess pain scores
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
121 participants (actual)

Study arms

  • Experimental
    Ketorolac

    Drug: Ketorolac

  • Placebo comparator
    Placebo

    Drug: Normal Saline

Interventions

06

What researchers measure

Primary outcomes

  1. Pain post-tonsillectomy

    pain post-tonsillectomy

    Time frame: post-operative

07

Study locations

1 site
  • Stollery Children's Hospital
    Edmonton, Alberta T6G 2B7, Canada
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2009 to primary completion in May 2013, 44 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 21, 2011
First posted
Dec 23, 2011
StartActual
Sep 2009
Primary completionActual
May 2013
CompletionActual
Jul 2013
Last update
Mar 25, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01498796
Responsible party
Sponsor
First posted
Dec 23, 2011
Start date
Sep 2009
Primary completion
May 2013
Completion
Jul 2013
Last update
Mar 25, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Ketorolac

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