Health Sciences Center
Winnipeg, Manitoba, R3A 1S1, Canada
NCT Number: NCT02425202
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.
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Notify Me1 year–17 year
All sexes
Interventional
Phase 4
Winnipeg, Manitoba, R3A 1S1, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Post-operative continuous infusion until 0600 the next day
Other names: Ketalar
Post-operative continuous infusion until 0600 the next day
Other names: Placebo comparator
Time frame: 24 hrs
Influence of low-dose continuous ketamine infusion on post-operative opioid requirements after tonsillectomy in OSA patients.
Time frame: 24 hrs
Influence of low-dose ketamine infusion on respiratory morbidity after tonsillectomy in OSA patients
University of Manitoba
Other
Ketamine Infusion for Pediatric Patients With Obstructive Sleep Apnea Syndrome After Tonsillectomy: A Randomized Controlled Trial
Acronym: KOSATA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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