Obstructive Sleep Apnea Syndrome
Conditions
Keywords
pediatric, obstructive sleep apnea, tonsillectomy, analgesia
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.
Interventions
DRUGKetamine
Post-operative continuous infusion until 0600 the next day
OTHERSaline infusion
Post-operative continuous infusion until 0600 the next day
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
Yes
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..
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of post-operative opioid requirements after tonsillectomy in obstructive sleep apnea (OSA) patients | 24 hrs | Influence of low-dose continuous ketamine infusion on post-operative opioid requirements after tonsillectomy in OSA patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Documentation of respiratory morbidity after tonsillectomy in OSA patients | 24 hrs | Influence of low-dose ketamine infusion on respiratory morbidity after tonsillectomy in OSA patients |
Countries
Canada
Outcome results
None listed