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

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ClinicalTrials.gov Identifier: NCT01498796
Recruitment Status : Unknown
Verified December 2011 by Ban Tsui, University of Alberta.
Recruitment status was:  Recruiting
First Posted : December 23, 2011
Last Update Posted : December 23, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Recurrent Acute Tonsillitis Drug: Ketorolac Drug: Normal Saline

  Show Detailed Description

Study Design

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis
Drug Information available for: Ketorolac
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ketorolac Drug: Ketorolac
Placebo Comparator: Placebo Drug: Normal Saline


Outcome Measures

Primary Outcome Measures :
  1. Pain

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ban Tsui, MD, University of Alberta
ClinicalTrials.gov Identifier: NCT01498796     History of Changes
Other Study ID Numbers: Pro00002357
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Tonsillitis
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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action