Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery

Boston Children's Hospital

Status: Enrolling

Conditions: Opioid Analgesic Adverse Reaction; Emergence Delirium; Post-operative Nausea and Vomiting (PONV); Tonsillitis; Pain; Anesthesia

Treatments: Drug: Morphine; Drug: Ketorolac; Drug: Acetaminophen; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06326983

IRB-P00047028

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

Opioid-Sparing Anesthetic Plan

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Drug: Acetaminophen

Drug: Ketorolac

Opioid Anesthetic Plan

Active Comparator group

Description:

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.

Treatment:

Drug: Acetaminophen

Drug: Ketorolac

Drug: Morphine