Clinical trial NCT02987985: 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
Overall status: COMPLETED
Phase: PHASE3
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
Keywords: Opioid-sparing
Opioid-free
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 50
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Respiratory depression
timeFrame: 24 hours following surgery
Secondary outcomes:
measure: Quantified opioid consumption
timeFrame: 24 hours following surgery
measure: Pediatric Agitation Emergence Delirium (PAED) scale
timeFrame: 24 hours following surgery
measure: Face Legs Activity Cry Consolability (FLACC) scale
timeFrame: 24 hours following surgery
measure: Time until Post Anesthesia Care Unit (PACU) discharge readiness
timeFrame: 24 hours following surgery
measure: Other adverse effects
timeFrame: 24 hours following surgery
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Jon Gamble, MD
role: PRINCIPAL_INVESTIGATOR
References: