Clinical trial NCT06326983: Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery
Official title: Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery; a Randomized, Controlled, Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tonsillitis
Post-operative Nausea and Vomiting (PONV)
Emergence Delirium
Opioid Analgesic Adverse Reaction
Anesthesia
Pain
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 58
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Median Pain Scores in the Post-Anesthesia Care Unit
timeFrame: entry to post-anesthesia care unit to 2-6 hours post-operatively
measure: Post-operative pain at 12-24 hours
timeFrame: 12-24 hours post-operatively
measure: Post Operative Anesthesia Unit Length of Stay (hours)
timeFrame: 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
Secondary outcomes:
measure: Opioid rescue medication administration
timeFrame: surgery end to 2-6 hours post-operatively
measure: Emergence Delirium
timeFrame: surgery end to 2-6 hours post-operatively
measure: Post-operative nausea and vomiting
timeFrame: surgery end to 2-6 hours post-operatively
measure: Procedure length (minutes)
timeFrame: 0-60 minutes
measure: Intraoperative Blood pressure (mmHg)
timeFrame: 10 minutes
measure: Intraoperative Heart rate (beats per second)
timeFrame: 10 minutes
measure: Vasopressor administration
timeFrame: 0-60 minutes
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References: