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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-7
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ropivacaine

    Procedure/Surgery

    Administration of ropivacaine in a Suprazygomatic maxillary nerve block

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Group ROther 1 intervention
Group B: Group RDExperimental treatment 1 intervention
Group C: Group DOther 1 intervention

Trial outcomes

Primary outcomes

1

Opioid-free recovery

Incidence of patients not requiring opioids in the PACU after surgery

Time frame
2 hours

Secondary outcomes

1

Number of patients with postoperative Pain

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

Time frame
2 hours
2

Number of Patients with Emergence Delirium

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.

Time frame
2 hours
3

Pain through follow-up

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

Time frame
7 days
4

Quality of Recovery through follow-up

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

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: