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

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ClinicalTrials.gov Identifier: NCT02987985
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Jonathan Gamble, University of Saskatchewan

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.

Condition or disease Intervention/treatment Phase
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 Drug: Acetaminophen, gabapentin Drug: Acetaminophen Drug: Ketamine , Lidocaine , Dexmedetomidine Drug: Fentanyl, Dexmedetomidine Drug: Dexamethasone , Ondansetron Drug: Sevoflurane Drug: Sevoflurane, Fentanyl Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy: a Pilot Study
Actual Study Start Date : October 15, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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 Name: Opioid-free preoperative medications

Drug: Ketamine , Lidocaine , Dexmedetomidine
Ketamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg
Other Name: Opioid-free pre-intubation medications

Drug: Dexamethasone , Ondansetron
Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg
Other Name: Postoperative nausea and vomiting prophylaxis

Drug: Sevoflurane
Sevoflurane (dose titrated to effect)
Other Name: 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: Acetaminophen
acetaminophen 15 mg/kg
Other Name: Opioid-sparing preoperative medications

Drug: Fentanyl, Dexmedetomidine
Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg
Other Name: Opioid sparing pre-intubation medications

Drug: Dexamethasone , Ondansetron
Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg
Other Name: Postoperative nausea and vomiting prophylaxis

Drug: Sevoflurane, Fentanyl
Sevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion)
Other Name: Opioid-sparing maintenance medications




Primary Outcome Measures :
  1. 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 [ Time Frame: 24 hours following surgery ]

Secondary Outcome Measures :
  1. Quantified opioid consumption [ Time Frame: 24 hours following surgery ]
  2. Pediatric Agitation Emergence Delirium (PAED) scale [ Time Frame: 24 hours following surgery ]
  3. Face Legs Activity Cry Consolability (FLACC) scale [ Time Frame: 24 hours following surgery ]
  4. Time until Post Anesthesia Care Unit (PACU) discharge readiness [ Time Frame: 24 hours following surgery ]
  5. Other adverse effects [ Time Frame: 24 hours following surgery ]


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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 0-5 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 > 5; 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987985


Contacts
Contact: Jon Gamble, MD 1-306-655-1183 jonathan.gamble@saskhealthauthority.ca

Locations
Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Jon Gamble    1-306-655-1183      
Sponsors and Collaborators
University of Saskatchewan

Responsible Party: Jonathan Gamble, Principle Investigator, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT02987985     History of Changes
Other Study ID Numbers: BIO 16-255
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Jonathan Gamble, University of Saskatchewan:
Opioid-sparing
Opioid-free

Additional relevant MeSH terms:
Depression
Depressive Disorder
Sleep Apnea, Obstructive
Postoperative Complications
Pathologic Processes
Respiratory Insufficiency
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Anesthetics
Lidocaine
Ketamine
Fentanyl
Sevoflurane
Dexamethasone acetate
Dexamethasone
Ondansetron
Dexmedetomidine
Acetaminophen
Gabapentin
BB 1101
Analgesics, Opioid