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

Sponsor

University of Saskatchewan (Other)

Overall Status

Completed

CT.gov ID

NCT02987985

Collaborator

(none)

Enrollment

Location

Arms

38.2

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

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

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.

Study Design

Study Type:

Interventional

Actual 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 :

Oct 15, 2017

Actual Primary Completion Date :

Sep 20, 2019

Actual Study Completion Date :

Dec 20, 2020

Arms and Interventions

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 Names: Opioid-free preoperative medications Drug: Ketamine , Lidocaine , Dexmedetomidine Ketamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg Other Names: Opioid-free pre-intubation medications Drug: Dexamethasone , Ondansetron Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg Other Names: Postoperative nausea and vomiting prophylaxis Drug: Sevoflurane Sevoflurane (dose titrated to effect) Other Names: 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 Names: Opioid-sparing preoperative medications Drug: Fentanyl, Dexmedetomidine Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg Other Names: Opioid sparing pre-intubation medications Drug: Dexamethasone , Ondansetron Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg Other Names: Postoperative nausea and vomiting prophylaxis Drug: Sevoflurane, Fentanyl Sevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion) Other Names: Opioid-sparing maintenance medications

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 Names:

Opioid-free preoperative medications

Drug: Ketamine , Lidocaine , Dexmedetomidine

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

Other Names:

Opioid-free pre-intubation medications

Drug: Dexamethasone , Ondansetron

Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg

Other Names:

Postoperative nausea and vomiting prophylaxis

Drug: Sevoflurane

Sevoflurane (dose titrated to effect)

Other Names:

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 Names:

Opioid-sparing preoperative medications

Drug: Fentanyl, Dexmedetomidine

Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg

Other Names:

Opioid sparing pre-intubation medications

Drug: Dexamethasone , Ondansetron

Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg

Other Names:

Postoperative nausea and vomiting prophylaxis

Drug: Sevoflurane, Fentanyl

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

Other Names:

Opioid-sparing maintenance medications

Outcome Measures

Primary Outcome Measures

Respiratory depression [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 Outcome Measures

Quantified opioid consumption [24 hours following surgery]
Quantified opioid consumption
Pediatric Agitation Emergence Delirium (PAED) scale [24 hours following surgery]
Pediatric Agitation Emergence Delirium (PAED) scale
Face Legs Activity Cry Consolability (FLACC) scale [24 hours following surgery]
Face Legs Activity Cry Consolability (FLACC) scale
Time until Post Anesthesia Care Unit (PACU) discharge readiness [24 hours following surgery]
Time until Post Anesthesia Care Unit (PACU) discharge readiness
Other adverse effects [24 hours following surgery]
Other adverse effects

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 12 Years

Sexes Eligible for Study:

All

Accepts 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