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

This study is currently recruiting participants.
Verified December 2011 by University of Alberta
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
History of Changes
  Purpose

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.


Condition Intervention
Recurrent Acute Tonsillitis
 Drug: Ketorolac
Drug: Normal Saline

Study Type: Interventional
Official Title: KITS Study -Ketorolac In Tonsillectomy Surgery: a Double Blinded, Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Pain

Arms Assigned Interventions
Experimental: Ketorolac Drug: Ketorolac
Placebo Comparator: Placebo Drug: Normal Saline

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 15 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01498796

Locations
Canada, Alberta
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Eduard Eksteen, MD     780.407.2109     Eduard Eksteen <Eduard.Eksteen@albertahealthservices.ca>    
Sub-Investigator: Morgan A Langille, MD            
Sub-Investigator: David WJ Cote, MD            
Sub-Investigator: Trina Uwiera, MD            
Sub-Investigator: Paula Holinski, MD            
Principal Investigator: Eduard Eksteen, MD            
Principal Investigator: Ban Tsui, MD            
Sponsors and Collaborators
University of Alberta
  More Information

No publications provided

Responsible Party: Ban Tsui, MD, University of Alberta
ClinicalTrials.gov Identifier: NCT01498796     History of Changes
Other Study ID Numbers: Pro00002357
Study First Received: December 21, 2011
Last Updated: December 22, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Peritonsillar Abscess
Tonsillitis
Abscess
Suppuration
Infection
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013