NCT07013526

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

June 2, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

June 2, 2025

Last Update Submit

June 2, 2025

Conditions

Adenotonsillectomy

Keywords

painopioid-free recoverySuprazygomatic maxillary nerve block

Outcome Measures

Primary Outcomes (1)

  • Opioid-free recovery

    Incidence of patients not requiring opioids in the PACU after surgery

    2 hours

Secondary Outcomes (4)

  • Number of patients with postoperative Pain

    2 hours

  • Number of Patients with Emergence Delirium

    2 hours

  • Pain through follow-up

    7 days

  • Quality of Recovery through follow-up

    7 days

Study Arms (3)

Group R

OTHER

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.

Procedure: Ropivacaine

Group RD

EXPERIMENTAL

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.

Procedure: Ropivacaine

Group D

OTHER

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.

Procedure: Ropivacaine

Interventions

RopivacainePROCEDURE

Administration of ropivacaine in a Suprazygomatic maxillary nerve block

Group DGroup RGroup RD

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Gianluca Bertolizio, MD, FRCPC

CONTACT

514586-2674gianluca.bertolizo@mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 2, 2025

First Posted

June 10, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)