A Phase 4 interventional study of Ketamine and Saline infusion in Obstructive Sleep Apnea Syndrome, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 1 Year to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-15.
Sponsored by University of Manitoba · Phase 4, Interventional, and Treatment
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.
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 36 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ketamine infusion at 0.1 mg/kg/hr up to maximum of 10 mg/hr
Drug: Ketamine
Saline infusion
Other: Saline infusion
Post-operative continuous infusion until 0600 the next day
Also known as: Ketalar
Post-operative continuous infusion until 0600 the next day
Also known as: Placebo comparator
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.
Time frame: 24 hrs
Documentation of respiratory morbidity after tonsillectomy in OSA patients
Influence of low-dose ketamine infusion on respiratory morbidity after tonsillectomy in OSA patients
Time frame: 24 hrs
Plan to share: No
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University of Manitoba