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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-15

Study Completion Date

2020-12-20

Brief Summary

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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.

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Detailed Description

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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

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Opioid-free anesthesia

Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis

Group Type EXPERIMENTAL

Acetaminophen, gabapentin

Intervention Type DRUG

acetaminophen 15 mg/kg, gabapentin 10 mg/kg

Ketamine , Lidocaine , Dexmedetomidine

Intervention Type DRUG

Ketamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg

Dexamethasone , Ondansetron

Intervention Type DRUG

Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg

Sevoflurane

Intervention Type DRUG

Sevoflurane (dose titrated to effect)

Opioid-sparing anesthesia

Opioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

acetaminophen 15 mg/kg

Fentanyl, Dexmedetomidine

Intervention Type DRUG

Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg

Dexamethasone , Ondansetron

Intervention Type DRUG

Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg

Sevoflurane, Fentanyl

Intervention Type DRUG

Sevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion)

Interventions

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Acetaminophen, gabapentin

acetaminophen 15 mg/kg, gabapentin 10 mg/kg

Intervention Type DRUG

Acetaminophen

acetaminophen 15 mg/kg

Intervention Type DRUG

Ketamine , Lidocaine , Dexmedetomidine

Ketamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg

Intervention Type DRUG

Fentanyl, Dexmedetomidine

Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg

Intervention Type DRUG

Dexamethasone , Ondansetron

Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg

Intervention Type DRUG

Sevoflurane

Sevoflurane (dose titrated to effect)

Intervention Type DRUG

Sevoflurane, Fentanyl

Sevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion)

Intervention Type DRUG

Other Intervention Names

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Opioid-free preoperative medications Opioid-sparing preoperative medications Opioid-free pre-intubation medications Opioid sparing pre-intubation medications Postoperative nausea and vomiting prophylaxis Opioid-free maintenance medication Opioid-sparing maintenance medications

Eligibility Criteria

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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

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No