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Completed

NCT Number: NCT02987985

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

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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Key information

Conditions

Anesthesia Analgesics Analgesics, Opioid Apnea Dexmedetomidine Dyssomnias Gabapentin General Anesthesia Ketamine Lidocaine Narcotics Nervous System Diseases Obstructive Sleep Apnea of Child Pathologic Processes Pathological Conditions, Signs and Symptoms Physiologic Effects of Drugs Postoperative Complications Pulse Oximetry Respiration Disorders Respiratory Depression Respiratory Insufficiency Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disordered Breathing Sleep Disorders, Intrinsic Sleep Wake Disorders Tonsillectomy

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen, gabapentin

Drug

acetaminophen 15 mg/kg, gabapentin 10 mg/kg

Other names: Opioid-free preoperative medications

Acetaminophen

Drug

acetaminophen 15 mg/kg

Other names: Opioid-sparing preoperative medications

Ketamine , Lidocaine , Dexmedetomidine

Drug

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

Other names: Opioid-free pre-intubation medications

Fentanyl, Dexmedetomidine

Drug

Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg

Other names: Opioid sparing pre-intubation medications

Dexamethasone , Ondansetron

Drug

Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg

Other names: Postoperative nausea and vomiting prophylaxis

Sevoflurane

Drug

Sevoflurane (dose titrated to effect)

Other names: Opioid-free maintenance medication

Sevoflurane, Fentanyl

Drug

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

Other names: Opioid-sparing maintenance medications

Primary outcomes

  1. Respiratory depression

    Time frame: 24 hours following surgery

    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 outcomes

  1. Quantified opioid consumption

    Time frame: 24 hours following surgery

    Quantified opioid consumption

  2. Pediatric Agitation Emergence Delirium (PAED) scale

    Time frame: 24 hours following surgery

    Pediatric Agitation Emergence Delirium (PAED) scale

  3. Face Legs Activity Cry Consolability (FLACC) scale

    Time frame: 24 hours following surgery

    Face Legs Activity Cry Consolability (FLACC) scale

  4. Time until Post Anesthesia Care Unit (PACU) discharge readiness

    Time frame: 24 hours following surgery

    Time until Post Anesthesia Care Unit (PACU) discharge readiness

  5. Other adverse effects

    Time frame: 24 hours following surgery

    Other adverse effects

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy: a Pilot Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Dec 9, 2016
Registry last updated
Aug 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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