Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy

Ketamine

Brief Summary

The objective of this trial is to determine whether an opioid-free general anesthetic (OFA) technique utilizing ketamine, dexmedetomidine, lidocaine, and gabapentin can help reduce postoperative respiratory depression in the post-anesthesia care unit and ward in children with sleep-disordered breathing undergoing tonsillectomy when compared with traditional opioid-containing techniques. It is expected that this OFA regimen will have a measurable reduction on postoperative respiratory depression in children with sleep-disordered breathing.

Intervention / Treatment

  • Drug: Acetaminophen, gabapentin
  • Drug: Acetaminophen
  • Drug: Ketamine , Lidocaine , Dexmedetomidine
  • Drug: Fentanyl, Dexmedetomidine
  • Drug: Dexamethasone , Ondansetron
  • Drug: Sevoflurane
  • Drug: Sevoflurane, Fentanyl

Condition or Disease

  • Anesthesia
  • General Anesthesia
  • Analgesics, Opioid
  • Postoperative Complications
  • Pathologic Processes
  • Physiologic Effects of Drugs
  • Narcotics
  • Analgesics
  • Sleep Disordered Breathing
  • Obstructive Sleep Apnea of Child
  • Tonsillectomy
  • Respiratory Depression
  • Dexmedetomidine
  • Ketamine
  • Lidocaine
  • Gabapentin
  • Pulse Oximetry

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: up to 12 Years   (Child)
Enrollment: 50 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Oct 15, 2017
Primary Completion: Sep 20, 2019
Completion Date: Dec 20, 2020
Study First Posted: Dec 09, 2016
Results First Posted: Aug 31, 2020
Last Updated: Apr 14, 2020

Sponsors / Collaborators

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

Location

Saskatoon, Saskatchewan, Canada

The objective of this trial is to determine whether an opioid-free general anesthetic can help reduce postoperative respiratory depression in the post-anesthesia care unit and ward in children with sleep-disordered breathing undergoing tonsillectomy when compared with traditional opioid-containing techniques.

Eligibility Criteria

Sex: All
Maximum Age: 12

This clinical trial is recruiting

Are you interested in participating in this trial or others? We'd love to help.

More Details

NCT Number: NCT02987985
Other IDs: BIO 16-255
Study URL: https://ClinicalTrials.gov/show/NCT02987985
Last updated: Jan 27, 2021