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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
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 September 18, 2014