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NCT Number: NCT07013526

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

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

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Key information

Conditions

Adenotonsillectomy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location contact

Gianluca Bertolizio, MD, FRCPC

CONTACT

[email protected]

5144124400

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ropivacaine

Procedure

Administration of ropivacaine in a Suprazygomatic maxillary nerve block

Primary outcomes

  1. Opioid-free recovery

    Time frame: 2 hours

    Incidence of patients not requiring opioids in the PACU after surgery

Secondary outcomes

  1. Number of patients with postoperative Pain

    Time frame: 2 hours

    Patients were classified as having pain if they had a Face, Activity, Cry, Consolability (FLACC) score that was greater than or equal to 3.

  2. Number of Patients with Emergence Delirium

    Time frame: 2 hours

    Patients 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.

  3. Pain through follow-up

    Time frame: 7 days

    Difference in pain between the groups, assessed with the Parents' Postoperative Pain Measure

  4. Quality of Recovery through follow-up

    Time frame: 7 days

    Differences in the Quality of recovery between the groups, as measured by the Post-Hospitalization Behavior Questionnaire for Ambulatory Surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Gianluca Bertolizio, MD, FRCPC

CONTACT

[email protected]

514586-2674

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: SZMB

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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