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

NCT ID: NCT07013526

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-12-30

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

Conditions

Adenotonsillectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group R

Group R will receive an SZMB of 0.15 ml/kg of local anesthetic ropivacaine 0.2% (max 5 ml). After the block, 0.1 ml/kg of normal saline will be administered intravenously. No dexmedetomidine will be given.

Group Type: OTHER

Ropivacaine

Intervention Type: PROCEDURE

Administration of ropivacaine in a Suprazygomatic maxillary nerve block

Group RD

2\. Group RD will receive an SZMB of 0.1 ml/kg of a solution of local anesthetic ropivacaine 0.2% and dexmedetomidine 1 mcg/ml (max 5 ml). After the block, 0.1 ml/kg of normal saline will be administered intravenously. No dexmedetomidine i.v. will be given.

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: PROCEDURE

Administration of ropivacaine in a Suprazygomatic maxillary nerve block

Group D

Group D will receive an SMB of 0.1 ml/kg of local anesthetic ropivacaine 0.2% (max 5 ml). After the block a bolus of intravenous dexmedetomidine 0.25 mcg/kg i.v. will be given.

Group Type: OTHER

Ropivacaine

Intervention Type: PROCEDURE

Administration of ropivacaine in a Suprazygomatic maxillary nerve block

Interventions

Ropivacaine

Administration of ropivacaine in a Suprazygomatic maxillary nerve block

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Bertolizio

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

McGill University Health Centre

Montreal, Quebec, Canada

Countries

Canada

Central Contacts

Gianluca Bertolizio, MD, FRCPC

Role: CONTACT

gianluca.bertolizo@mcgill.ca

514586-2674

Facility Contacts

Gianluca Bertolizio, MD, FRCPC

Role: primary

gianluca.bertolizio@mcgill.ca

5144124400

Other Identifiers

2026-11731

Identifier Type: -

Identifier Source: org_study_id