An interventional study of Dexmedetomidine and Acetaminophen in Tonsillitis, Post-operative Nausea and Vomiting (PONV) and Emergence Delirium, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
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.
103 studies on the registry are indexed under Tonsillitis; 12 are open to participants now.
This study's enrollment of 62 is below the median of 100 across 87 interventional studies indexed under Tonsillitis.
Browse Tonsillitis studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
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Exclusion Criteria:
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.
Drug: Dexmedetomidine · Drug: Acetaminophen · Drug: Ketorolac
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.
Drug: Acetaminophen · Drug: Ketorolac · Drug: Morphine
Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia
Also known as: Precedex
Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia).
Also known as: Ofirmev
Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery.
Also known as: Toradol
Morphine (0.1mg/kg given intravenously at induction of anesthesia)
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.
Time frame: 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.
Time frame: 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
Time frame: 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
Opioid rescue medication administration
Opioid rescue medications administered (reported as oral morphine equivalents)
Time frame: 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.
Time frame: 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
Time frame: surgery end to 2-6 hours post-operatively
Procedure length (minutes)
from incision time to patient being wheeled out of the operating room
Time frame: 0-60 minutes
Intraoperative Blood pressure (mmHg)
Range of systolic blood pressure within 10 minutes of anesthesia induction
Time frame: 10 minutes
Intraoperative Heart rate (beats per second)
Range of heart rate within 10 minutes of anesthesia induction
Time frame: 10 minutes
Vasopressor administration
Intraoperative administration of vasopressors
Time frame: 0-60 minutes
Plan to share: No
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Studies of the drug tested here: Dexmedetomidine