NCT02987985

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

Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy: a Pilot Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Acetaminophen, gabapentin	acetaminophen 15 mg/kg, gabapentin 10 mg/kg
DRUG	Acetaminophen	acetaminophen 15 mg/kg
DRUG	Ketamine , Lidocaine , Dexmedetomidine	Ketamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg
DRUG	Fentanyl, Dexmedetomidine	Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg
DRUG	Dexamethasone , Ondansetron	Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg
DRUG	Sevoflurane	Sevoflurane (dose titrated to effect)
DRUG	Sevoflurane, Fentanyl	Sevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion)

Timeline

• Start date: 2017-10-15
• Primary completion: 2019-09-20
• Completion: 2020-12-20
• First posted: 2016-12-09
• Last updated: 2021-08-10

Locations

1 site across 1 country: Canada