Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery

NCT06326983 — Not applicable, Completed, 62 participants, Boston Children's Hospital

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Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery; a Randomized, Controlled, Non-inferiority Study

Registry	NCT06326983
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	62 (Actual)
Sponsor	Boston Children's Hospital (Other)
Conditions	Tonsillitis, Post-operative Nausea and Vomiting (PONV), Emergence Delirium, Opioid Analgesic Adverse Reaction, Anesthesia, Pain
Interventions	Dexmedetomidine, Acetaminophen, Ketorolac, Morphine (Drug)
Dates	start 2024-05-09, primary completion 2026-01-30, completion 2026-03-01, first posted 2024-03-25, last updated 2026-05-18
Locations	1 site in United States

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Opioid-Sparing Anesthetic Plan	Experimental	Drug: Dexmedetomidine; Drug: Acetaminophen; Drug: Ketorolac	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.
Opioid Anesthetic Plan	Active comparator	Drug: Acetaminophen; Drug: Ketorolac; Drug: Morphine	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.

Dexmedetomidine (Drug), also known as Precedex: Dexmedetomidine (1mcg/kg bolus given intravenously at induction of anesthesia
Acetaminophen (Drug), also known as Ofirmev: Acetaminophen (12.5mg/kg with a maximum dose of 1 gram given intravenously at induction of anesthesia).
Ketorolac (Drug), also known as Toradol: Ketorolac 0.5mg/kg with a max dose of 30mg intravenously at the end of surgery.
Morphine (Drug): Morphine (0.1mg/kg given intravenously at induction of anesthesia)

+Outcome measures

Primary outcomes

Median Pain Scores in the Post-Anesthesia Care Unit [entry to post-anesthesia care unit to 2-6 hours post-operatively]: 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.
Post-operative pain at 12-24 hours [12-24 hours post-operatively]: Pain categorized as none, mild, moderate, and severe. Taken from the routine follow-up nursing phone call.
Post Operative Anesthesia Unit Length of Stay (hours) [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]: Length of time spent in the Post Operative Anesthesia Unit after tonsil surgery

Secondary outcomes

Opioid rescue medication administration [surgery end to 2-6 hours post-operatively]: Opioid rescue medications administered (reported as oral morphine equivalents)
Emergence Delirium [surgery end to 2-6 hours post-operatively]: 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.
Post-operative nausea and vomiting [surgery end to 2-6 hours post-operatively]: Incidence of episodes of emesis or administration of anti-emetics in the post-anesthesia care unit
Procedure length (minutes) [0-60 minutes]: from incision time to patient being wheeled out of the operating room
Intraoperative Blood pressure (mmHg) [10 minutes]: Range of systolic blood pressure within 10 minutes of anesthesia induction
Intraoperative Heart rate (beats per second) [10 minutes]: Range of heart rate within 10 minutes of anesthesia induction
Vasopressor administration [0-60 minutes]: Intraoperative administration of vasopressors

+Eligibility

Sex: All, ages: 3 Years to 17 Years

Inclusion Criteria:

* American Society of Anesthesia classification status I-III
* Ages 3 years to 17 years
* Scheduled for tonsillectomy or tonsillotomy with or without adenoidectomy at Boston Children's Hospital Waltham

Exclusion Criteria:

* Patients not scheduled for primary tonsillectomy/tonsillotomy.
* Patients with known coagulopathies
* Patients with previous chronic pain syndromes
* Patients with any condition/indication that would prevent them from being able to be randomized (i.e. allergy to one of the study medications)

+Locations (1)

Facility	City	Country	Status
Boston Children's Hospital	Waltham, Massachusetts	United States

My Notes

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