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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Drug: Acetaminophen, gabapentin
* Drug: Acetaminophen
* Drug: Ketamine , Lidocaine , Dexmedetomidine
* Drug: Fentanyl, Dexmedetomidine
* Drug: Dexamethasone , Ondansetron
* Drug: Sevoflurane
* Drug: Sevoflurane, Fentanyl


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opioid-free anesthesia<br>Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis | Drug: Acetaminophen, gabapentin<br>* acetaminophen 15 mg/kg, gabapentin 10 mg/kg<br>* Other names: Opioid-free preoperative medications;Drug: Ketamine , Lidocaine , Dexmedetomidine<br>* Ketamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg<br>* Other names: Opioid-free pre-intubation medications;Drug: Dexamethasone , Ondansetron<br>* Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg<br>* Other names: Postoperative nausea and vomiting prophylaxis;Drug: Sevoflurane<br>* Sevoflurane (dose titrated to effect)<br>* Other names: Opioid-free maintenance medication;|
| Active Comparator: Opioid-sparing anesthesia<br>Opioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis | Drug: Acetaminophen<br>* acetaminophen 15 mg/kg<br>* Other names: Opioid-sparing preoperative medications;Drug: Fentanyl, Dexmedetomidine<br>* Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg<br>* Other names: Opioid sparing pre-intubation medications;Drug: Dexamethasone , Ondansetron<br>* Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg<br>* Other names: Postoperative nausea and vomiting prophylaxis;Drug: Sevoflurane, Fentanyl<br>* Sevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion)<br>* Other names: Opioid-sparing maintenance medications;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 hours following surgery | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Opioid-sparing, Opioid-free