Clinical trial NCT07013526: Dexmedetomidine as Adjuvant for Suprazygomatic Maxillary Nerve Block in Children's Adenotonsillectomy
Official title: Dexmedetomidine as Adjuvant for Suprazygomatic Maxillary Nerve Block in Children's Adenotonsillectomy: a Randomized Controlled Trial Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adenotonsillectomy
Keywords: pain
opioid-free recovery
Suprazygomatic maxillary nerve block
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinic trial is to evaluate the impact of dexmedetomidine as an adjunct pain pain medication on opioid-free recovery in children undergoing adenotonsillectomy with Suprazygomatic maxillary nerve block (SZMB). The main questions it aims to answer are:

* Does SZMB with the local anesthetic ropivacaine and the adjuvant dexmedetomidine result in less pain
* Is dexmedetomidine associated with an improved quality of recovery at home Researchers will compare pain in participants given an SZMB with ropivacaine and an adjuvant dexmedetomidine, participants given SZMB with ropivacaine only, and a SZMB with ropivacaine and dexmedetomidine given intravenously.

Participants will:

* Be given the SZMB during the surgery.
* Be evaluated after surgery to measure their opioid consumption, pain severity, level of agitation, and level of delirium
* Complete a daily questionnaire for 7 days after surgery on the patients pain and recovery


Eligibility criteria: Inclusion Criteria:

* Scheduled for elective partial adenotonsillectomy,
* STUBR score ≥ 3, indicating significant sleep-disordered breathing
* Patients whose parents are fluent in French of English will be enrolled

Exclusion Criteria:

* Scheduled to undergo total extracapsular adenotonsillectomy or adenoidectomy-only procedures
* Patient requires prolonged intubation postoperatively
* the anesthesiologist does not adhere to the standardized anesthesia protocol
* Patients with neurological or cardiac congenital deficits, with cardiac arrhythmias (non-sinus rhythm), implanted pacemakers, on chronic therapy with drugs that have known effects on sympathetic and parasympathetic activity (antimuscarinics, beta-2 adrenergic agonists, alpha-1 adrenergic antagonists or antiarrhythmic agents, tricyclic antidepressants)
* ASA physical status III or higher
* Parent/legal guardians refuses to participate
* Patients scheduled for surgery without an appointment at the Montreal Children's Hospital (MCH) Preoperative Clinic will not be enrolled in the study.

Primary outcomes:
measure: Opioid-free recovery
timeFrame: 2 hours
Secondary outcomes:
measure: Number of patients with postoperative Pain
timeFrame: 2 hours
measure: Number of Patients with Emergence Delirium
timeFrame: 2 hours
measure: Pain through follow-up
timeFrame: 7 days
measure: Quality of Recovery through follow-up
timeFrame: 7 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
References: