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This is a prospective, randomized, controlled, non-inferiority study of patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. The overall aim is to evaluate the efficacy of an opioid anesthetic plan (morphine, ketorolac, and acetaminophen versus an opioid sparing anesthetic plan (dexmedetomidine, ketorolac and acetaminophen) for perioperative analgesia and recovery time in patients undergoing tonsillectomies and tonsillotomies at Boston Children's Hospital Waltham. Secondary measures include rescue opioids administered in post-anesthesia care unit (PACU), re-operation secondary to bleeding, emergence delirium, post-operative nausea and vomiting, intraoperative hemodynamics, intraoperative vasopressor administration, and length of procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid-Sparing Anesthetic Plan | Experimental | For their tonsil surgery, subjects will receive Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). Ketorolac 0.5mg/kg with a max dose of 30mg given intravenously at the end of surgery. No opioids will be given during the procedure. |
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| Opioid Anesthetic Plan | Active Comparator | For their tonsil surgery, subjects will receive Morphine (0.1mg/kg given intravenously at induction of anesthesia) and Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Pain Scores in the Post-Anesthesia Care Unit | Median Pain Scores in the Post-Anesthesia Care Unit measured by the numeric rating scale (NRS), Wong-Baker Faces scale or FLACC (Face, Legs, Activity, Cry, Consolability) scale as indicated based on patient age and development. All scales are done on a 0-10 point scale with 0 being no pain and 10 being the highest pain. | entry to post-anesthesia care unit to 2-6 hours post-operatively |
| Post-operative pain at 12-24 hours | Pain categorized as none, mild, moderate, and severe. Taken from the routine follow-up nursing phone call. | 12-24 hours post-operatively |
| Post Operative Anesthesia Unit Length of Stay (hours) | Length of time spent in the Post Operative Anesthesia Unit after tonsil surgery | From entry to the Post Anesthesia Care Unit to exit from the Post-Anesthesia Care Unit. Assessed for up to 8 hours on the date of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid rescue medication administration | Opioid rescue medications administered (reported as oral morphine equivalents) | surgery end to 2-6 hours post-operatively |
| Emergence Delirium | Incidence of emergence delirium defined as a score ≥ 10 on the Pediatric Anesthesia Emergence Delirium Scale. Scores range 0-20 with 0 being no agitation/delirium to 20 being the highest level. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Waltham | Massachusetts | 02453 | United States |
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| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| D014839 | Vomiting |
| D000071257 | Emergence Delirium |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000082 | Acetaminophen |
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Acetaminophen | Drug | Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia). |
|
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| Ketorolac | Drug | Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery. |
|
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| Morphine | Drug | Morphine (0.1mg/kg given intravenously at induction of anesthesia) |
|
| surgery end to 2-6 hours post-operatively |
| Post-operative nausea and vomiting | Incidence of episodes of emesis or administration of anti-emetics in the post-anesthesia care unit | surgery end to 2-6 hours post-operatively |
| Procedure length (minutes) | from incision time to patient being wheeled out of the operating room | 0-60 minutes |
| Intraoperative Blood pressure (mmHg) | Range of systolic blood pressure within 10 minutes of anesthesia induction | 10 minutes |
| Intraoperative Heart rate (beats per second) | Range of heart rate within 10 minutes of anesthesia induction | 10 minutes |
| Vasopressor administration | Intraoperative administration of vasopressors | 0-60 minutes |
| D009057 |
| Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |