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

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.

Intervention / Treatment

  • Drug: Ketamine
  • Other: Saline infusion

Condition or Disease

  • Obstructive Sleep Apnea Syndrome

Phase

Study Design

Study type: Interventional
Status: Completed
Study results: No Results Available
Age: 1 Year to 17 Years   (Child)
Enrollment: 36 ()
Funded by: Other

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Clinical Trial Dates

Start date: Dec 14, 2022
Primary Completion: May 03, 2018
Completion Date: May 03, 2018
Study First Posted: Apr 23, 2015
Results First Posted: Aug 31, 2020
Last Updated: Oct 15, 2018

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

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.

Eligibility Criteria

Sex: All
Minimum Age: 1
Maximum Age: 17

More Details

NCT Number: NCT02425202
Acronym: KOSATA
Other IDs: B2013:163
Study URL: https://ClinicalTrials.gov/show/NCT02425202
Last updated: Jun 17, 2022