Dexmedetomidine as Adjuvant for Suprazygomatic Maxillary Nerve Block in Children's Adenotonsillectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ropivacaine.
- Who it may be relevant to
- Registry conditions: Adenotonsillectomy. Basic parameters: 2 years — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dexmedetomidine as Adjuvant for Suprazygomatic Maxillary Nerve Block in Children's Adenotonsillectomy: a Randomized Controlled Trial Study
Overview
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
- Procedure Ropivacaine
Administration of ropivacaine in a Suprazygomatic maxillary nerve block
Primary outcome measures
- Opioid-free recovery [Time frame: 2 hours]
Secondary outcome measures (4)
- Number of patients with postoperative Pain [Time frame: 2 hours]
- Number of Patients with Emergence Delirium [Time frame: 2 hours]
- Pain through follow-up [Time frame: 7 days]
- Quality of Recovery through follow-up [Time frame: 7 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Canada · 1 center
- McGill University Health Centre — Montreal
Identifiers
NCT: NCT07013526 · 2026-11731