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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid-free anesthesia | Experimental | Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis |
|
| Opioid-sparing anesthesia | Active Comparator | Opioid-sparing preoperative medications, Opioid sparing pre-intubation medications, Opioid-sparing maintenance medications, postoperative nausea and vomiting prophylaxis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen, gabapentin | Drug | acetaminophen 15 mg/kg, gabapentin 10 mg/kg |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Gamble, MD | University of Saskatchewan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
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| Acetaminophen | Drug | acetaminophen 15 mg/kg |
|
|
| Ketamine , Lidocaine , Dexmedetomidine | Drug | Ketamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg |
|
|
| Fentanyl, Dexmedetomidine | Drug | Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg |
|
|
| Dexamethasone , Ondansetron | Drug | Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg |
|
|
| Sevoflurane | Drug | Sevoflurane (dose titrated to effect) |
|
|
| Sevoflurane, Fentanyl | Drug | Sevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion) |
|
|
| 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 |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D012891 | Sleep Apnea Syndromes |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000077206 | Gabapentin |
| D007649 | Ketamine |
| D008012 | Lidocaine |
| D020927 | Dexmedetomidine |
| D005283 | Fentanyl |
| D003907 | Dexamethasone |
| D017294 | Ondansetron |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
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