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

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.

Study Overview

• Status: Completed
• Conditions: Pathologic Processes; Postoperative Complications; Sleep Disordered Breathing; Anesthesia; Ketamine; General Anesthesia; Dexmedetomidine; Tonsillectomy; Respiratory Depression; Analgesics, Opioid; Pulse Oximetry; Lidocaine; Analgesics; Gabapentin; Narcotics; Obstructive Sleep Apnea of Child; Physiologic Effects of Drugs
• Intervention / Treatment: Drug: Acetaminophen, gabapentin; Drug: Ketamine , Lidocaine , Dexmedetomidine; Drug: Dexamethasone , Ondansetron; Drug: Sevoflurane; Drug: Acetaminophen; Drug: Fentanyl, Dexmedetomidine; Drug: Sevoflurane, Fentanyl

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 0-12 years with Sleep Disordered Breathing (SDB) who are scheduled for elective Tonsillectomy/AdenoTonsillectomy (T/AT) will be recruited at Royal University Hospital, Saskatoon, Saskatchewan.

Exclusion Criteria:

• age > 12; American Society of Anesthesiologists (ASA) Classification > IV; significant cardiorespiratory, neurological, craniofacial, hepatic, renal, or genetic disorders, excluding SDB; concomitant surgical procedures other than myringotomy and tubes; and allergy to any of the study drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Opioid-free anesthesia; Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis	Drug: Acetaminophen, gabapentin; acetaminophen 15 mg/kg, gabapentin 10 mg/kg; Other Names: Opioid-free preoperative medications; Drug: Ketamine , Lidocaine , Dexmedetomidine; Ketamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg; Other Names: Opioid-free pre-intubation medications; Drug: Dexamethasone , Ondansetron; Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg; Other Names: Postoperative nausea and vomiting prophylaxis; Drug: Sevoflurane; Sevoflurane (dose titrated to effect); Other Names: Opioid-free maintenance medication
ACTIVE_COMPARATOR: Opioid-sparing anesthesia; Opioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis	Drug: Dexamethasone , Ondansetron; Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg; Other Names: Postoperative nausea and vomiting prophylaxis; Drug: Acetaminophen; acetaminophen 15 mg/kg; Other Names: Opioid-sparing preoperative medications; Drug: Fentanyl, Dexmedetomidine; Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg; Other Names: Opioid sparing pre-intubation medications; Drug: Sevoflurane, Fentanyl; Sevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion); Other Names: Opioid-sparing maintenance medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory depression	Number of desaturation events (oxygen saturation by pulse oximetry (SPO2) <90%) as measured by a Masimo Radical-7 pulse oximeter during the first postoperative night's sleep	24 hours following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantified opioid consumption	Quantified opioid consumption	24 hours following surgery
Pediatric Agitation Emergence Delirium (PAED) scale	Pediatric Agitation Emergence Delirium (PAED) scale	24 hours following surgery
Face Legs Activity Cry Consolability (FLACC) scale	Face Legs Activity Cry Consolability (FLACC) scale	24 hours following surgery
Time until Post Anesthesia Care Unit (PACU) discharge readiness	Time until Post Anesthesia Care Unit (PACU) discharge readiness	24 hours following surgery
Other adverse effects	Other adverse effects	24 hours following surgery

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Investigators: Principal Investigator: Jon Gamble, MD, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2017
• Primary Completion (ACTUAL): September 20, 2019
• Study Completion (ACTUAL): December 20, 2020

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (ESTIMATE): December 9, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Opioid-free; Opioid-sparing
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Mood Disorders; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Depression; Depressive Disorder; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Insufficiency; Postoperative Complications; Pathologic Processes; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Platelet Aggregation Inhibitors; Antipyretics; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Dermatologic Agents; Narcotics; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Serotonin Agents; Serotonin Antagonists; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; Anticonvulsants; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Antimanic Agents; Anesthetics, Inhalation; Antipruritics; Ketamine; Dexamethasone; Fentanyl; Dexmedetomidine; Lidocaine; Gabapentin; Acetaminophen; Sevoflurane; Analgesics, Opioid; Ondansetron
• Other Study ID Numbers: BIO 16-255

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No