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Dexmedetomidine as Adjuvant for Suprazygomatic Maxillary Nerve Block in Children's Adenotonsillectomy

Dexmedetomidine as Adjuvant for Suprazygomatic Maxillary Nerve Block in Children's Adenotonsillectomy: a Randomized Controlled Trial Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07013526
Acronym
SZMB
Enrollment
150
Registered
2025-06-10
Start date
2025-09-01
Completion date
2027-12-30
Last updated
2025-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenotonsillectomy

Keywords

pain, opioid-free recovery, Suprazygomatic maxillary nerve block

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

Interventions

PROCEDURERopivacaine

Administration of ropivacaine in a Suprazygomatic maxillary nerve block

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Opioid-free recovery2 hoursIncidence of patients not requiring opioids in the PACU after surgery

Secondary

MeasureTime frameDescription
Number of patients with postoperative Pain2 hoursPatients were classified as having pain if they had a Face, Activity, Cry, Consolability (FLACC) score that was greater than or equal to 3.
Number of Patients with Emergence Delirium2 hoursPatients were classified as having emergence delirium if they had a score on the emergence delirium scale that was greater than or equal to 10 in the Post-anesthesia care unit.
Pain through follow-up7 daysDifference in pain between the groups, assessed with the Parents' Postoperative Pain Measure
Quality of Recovery through follow-up7 daysDifferences in the Quality of recovery between the groups, as measured by the Post-Hospitalization Behavior Questionnaire for Ambulatory Surgery.

Countries

Canada

Contacts

Primary ContactGianluca Bertolizio, MD, FRCPC
gianluca.bertolizo@mcgill.ca514586-2674

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026