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

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.

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

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)

Sponsors & Collaborators

• University of Saskatchewan

  lead OTHER

Principal Investigators

• Jon Gamble, MD · University of Saskatchewan

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-15

Primary Completion

2019-09-20

Completion

2020-12-20

Countries

• Canada

Study Locations