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

Primary Purpose

Anesthesia, General Anesthesia, Analgesics, Opioid

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Acetaminophen, gabapentin
Acetaminophen
Ketamine , Lidocaine , Dexmedetomidine
Fentanyl, Dexmedetomidine
Dexamethasone , Ondansetron
Sevoflurane
Sevoflurane, Fentanyl
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia focused on measuring Opioid-sparing, Opioid-free

Eligibility Criteria

undefined - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Opioid-free anesthesia

Opioid-sparing anesthesia

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quantified opioid consumption
Quantified opioid consumption
Pediatric Agitation Emergence Delirium (PAED) scale
Pediatric Agitation Emergence Delirium (PAED) scale
Face Legs Activity Cry Consolability (FLACC) scale
Face Legs Activity Cry Consolability (FLACC) scale
Time until Post Anesthesia Care Unit (PACU) discharge readiness
Time until Post Anesthesia Care Unit (PACU) discharge readiness
Other adverse effects
Other adverse effects

Full Information

First Posted
November 29, 2016
Last Updated
August 6, 2021
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT02987985
Brief Title
Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy
Official Title
Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2017 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
December 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Opioid-sparing, Opioid-free

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Opioid-free anesthesia
Arm Type
Experimental
Arm Description
Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis
Arm Title
Opioid-sparing anesthesia
Arm Type
Active Comparator
Arm Description
Opioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis
Intervention Type
Drug
Intervention Name(s)
Acetaminophen, gabapentin
Other Intervention Name(s)
Opioid-free preoperative medications
Intervention Description
acetaminophen 15 mg/kg, gabapentin 10 mg/kg
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Opioid-sparing preoperative medications
Intervention Description
acetaminophen 15 mg/kg
Intervention Type
Drug
Intervention Name(s)
Ketamine , Lidocaine , Dexmedetomidine
Other Intervention Name(s)
Opioid-free pre-intubation medications
Intervention Description
Ketamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg
Intervention Type
Drug
Intervention Name(s)
Fentanyl, Dexmedetomidine
Other Intervention Name(s)
Opioid sparing pre-intubation medications
Intervention Description
Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg
Intervention Type
Drug
Intervention Name(s)
Dexamethasone , Ondansetron
Other Intervention Name(s)
Postoperative nausea and vomiting prophylaxis
Intervention Description
Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Opioid-free maintenance medication
Intervention Description
Sevoflurane (dose titrated to effect)
Intervention Type
Drug
Intervention Name(s)
Sevoflurane, Fentanyl
Other Intervention Name(s)
Opioid-sparing maintenance medications
Intervention Description
Sevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion)
Primary Outcome Measure Information:
Title
Respiratory depression
Description
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
Time Frame
24 hours following surgery
Secondary Outcome Measure Information:
Title
Quantified opioid consumption
Description
Quantified opioid consumption
Time Frame
24 hours following surgery
Title
Pediatric Agitation Emergence Delirium (PAED) scale
Description
Pediatric Agitation Emergence Delirium (PAED) scale
Time Frame
24 hours following surgery
Title
Face Legs Activity Cry Consolability (FLACC) scale
Description
Face Legs Activity Cry Consolability (FLACC) scale
Time Frame
24 hours following surgery
Title
Time until Post Anesthesia Care Unit (PACU) discharge readiness
Description
Time until Post Anesthesia Care Unit (PACU) discharge readiness
Time Frame
24 hours following surgery
Title
Other adverse effects
Description
Other adverse effects
Time Frame
24 hours following surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Gamble, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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