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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ketamine Infusion for Pediatric Patients With Obstructive Sleep Apnea Syndrome After Tonsillectomy: A Randomized Controlled Trial

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Drug: Ketamine
* Other: Saline infusion


Participation Criteria
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Eligibility Criteria
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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..

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine infusion<br>Ketamine infusion at 0.1 mg/kg/hr up to maximum of 10 mg/hr | Drug: Ketamine<br>* Post-operative continuous infusion until 0600 the next day<br>* Other names: Ketalar;|
| Placebo Comparator: Saline infusion<br>Saline infusion | Other: Saline infusion<br>* Post-operative continuous infusion until 0600 the next day<br>* Other names: Placebo comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of post-operative opioid requirements after tonsillectomy in obstructive sleep apnea (OSA) patients | Influence of low-dose continuous ketamine infusion on post-operative opioid requirements after tonsillectomy in OSA patients. | 24 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of respiratory morbidity after tonsillectomy in OSA patients | Influence of low-dose ketamine infusion on respiratory morbidity after tonsillectomy in OSA patients | 24 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, obstructive sleep apnea, tonsillectomy, analgesia