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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Ropivacaine
Procedure/SurgeryAdministration of ropivacaine in a Suprazygomatic maxillary nerve block
Treatment groups
Trial outcomes
Primary outcomes
Opioid-free recovery
Incidence of patients not requiring opioids in the PACU after surgery
Secondary outcomes
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.
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.
Pain through follow-up
Difference in pain between the groups, assessed with the Parents' Postoperative Pain Measure
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.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: