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Ketamine Infusion for Pediatric Patients With Obstructive Sleep Apnea Syndrome (OSAS) After Tonsillectomy (KOSATA)

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ClinicalTrials.gov Identifier: NCT02425202
Recruitment Status : Completed
First Posted : April 23, 2015
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Manitoba

Tracking Information
First Submitted Date  ICMJE April 14, 2015
First Posted Date  ICMJE April 23, 2015
Last Update Posted Date October 15, 2018
Study Start Date  ICMJE December 2014
Actual Primary Completion Date May 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
Measurement of post-operative opioid requirements after tonsillectomy in obstructive sleep apnea (OSA) patients [ Time Frame: 24 hrs ]
Influence of low-dose continuous ketamine infusion on post-operative opioid requirements after tonsillectomy in OSA patients.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
Documentation of respiratory morbidity after tonsillectomy in OSA patients [ Time Frame: 24 hrs ]
Influence of low-dose ketamine infusion on respiratory morbidity after tonsillectomy in OSA patients
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Infusion for Pediatric Patients With Obstructive Sleep Apnea Syndrome (OSAS) After Tonsillectomy
Official Title  ICMJE Ketamine Infusion for Pediatric Patients With Obstructive Sleep Apnea Syndrome After Tonsillectomy: A Randomized Controlled Trial
Brief Summary The study will evaluate the post-operative morphine-sparing effect, pain reduction, and side effects of a continuous ketamine infusion after tonsillectomy in pediatric patients.
Detailed Description Eligible pediatric patients that are undergoing tonsillectomy for sleep-disordered breathing or obstructive sleep apnea AND are to be admitted into a monitored setting will be recruited for this study. They will be randomized into two groups:1) Control group receiving continuous infusion of saline (placebo) and 2) Study group receiving continuous infusion of low-dose ketamine at 0.1 mg/kg/hr. Both patients will receive scheduled oral acetaminophen and rescue intravenous morphine as required. The infusions will be stopped at 0600 the next morning. Morphine requirements, pain scores at selected times, central nervous system side effects, and adverse cardiorespiratory events will be recorded.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea Syndrome
Intervention  ICMJE
  • Drug: Ketamine
    Post-operative continuous infusion until 0600 the next day
    Other Name: Ketalar
  • Other: Saline infusion
    Post-operative continuous infusion until 0600 the next day
    Other Name: Placebo comparator
Study Arms  ICMJE
  • Active Comparator: Ketamine infusion
    Ketamine infusion at 0.1 mg/kg/hr up to maximum of 10 mg/hr
    Intervention: Drug: Ketamine
  • Placebo Comparator: Saline infusion
    Saline infusion
    Intervention: Other: Saline infusion
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2018)
36
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2015)
72
Actual Study Completion Date  ICMJE May 3, 2018
Actual Primary Completion Date May 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients requiring tonsillectomy for diagnosis of sleep disordered breathing/obstructive sleep apnea that will be admitted for overnight cardiorespiratory monitoring, based on positive polysomnography test, positive nocturnal home oximetry, or strong signs/symptoms of OSAS

Exclusion Criteria:

  • Patients with significant developmental delay, abnormal airway anatomy, significant co-morbidities such as cardiac disorders, respiratory disorders, neurological disorders, anad renal disorders.
  • Previous reaction to study medications.
  • Postoperative bleeding within the first 24 hours
  • Refusal to be involved in the study..
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02425202
Other Study ID Numbers  ICMJE B2013:163
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Manitoba
Study Sponsor  ICMJE University of Manitoba
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Harley Wong, MD, FRCPC University of Manitoba
PRS Account University of Manitoba
Verification Date May 2018

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