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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Drug: Ketamine Other: Saline infusion Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine Infusion for Pediatric Patients With Obstructive Sleep Apnea Syndrome After Tonsillectomy: A Randomized Controlled Trial
Study Start Date : December 2014
Actual Primary Completion Date : May 3, 2018
Actual Study Completion Date : May 3, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Ketamine infusion
Ketamine infusion at 0.1 mg/kg/hr up to maximum of 10 mg/hr
Drug: Ketamine
Post-operative continuous infusion until 0600 the next day
Other Name: Ketalar

Placebo Comparator: Saline infusion
Saline infusion
Other: Saline infusion
Post-operative continuous infusion until 0600 the next day
Other Name: Placebo comparator




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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..

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): NCT02425202


Locations
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Canada, Manitoba
Health Sciences Center
Winnipeg, Manitoba, Canada, R3A 1S1
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Harley Wong, MD, FRCPC University of Manitoba
Publications of Results:
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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT02425202    
Other Study ID Numbers: B2013:163
First Posted: April 23, 2015    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Manitoba:
pediatric
obstructive sleep apnea
tonsillectomy
analgesia
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action