Skip to main content
OpenTrials
Completed

NCT Number: NCT02425202

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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..

Treatment and study plan

ketamine

Drug

Post-operative continuous infusion until 0600 the next day

Other names: Ketalar

Saline infusion

Other

Post-operative continuous infusion until 0600 the next day

Other names: Placebo comparator

Primary outcomes

  1. Measurement of post-operative opioid requirements after tonsillectomy in obstructive sleep apnea (OSA) patients

    Time frame: 24 hrs

    Influence of low-dose continuous ketamine infusion on post-operative opioid requirements after tonsillectomy in OSA patients.

Secondary outcomes

  1. Documentation of respiratory morbidity after tonsillectomy in OSA patients

    Time frame: 24 hrs

    Influence of low-dose ketamine infusion on respiratory morbidity after tonsillectomy in OSA patients

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

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

Acronym: KOSATA

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 23, 2015
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.