An interventional study of Ropivacaine in Adenotonsillectomy, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Not yet recruiting at 1 site in Canada. Open to participants aged 2 Years to 7 Years. Per ClinicalTrials.gov, last updated 2025-06-10.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Prevention
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:
Participants will:
McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 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
Administration of ropivacaine in a Suprazygomatic maxillary nerve block
Opioid-free recovery
Incidence of patients not requiring opioids in the PACU after surgery
Time frame: 2 hours
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
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
Pain through follow-up
Difference in pain between the groups, assessed with the Parents' Postoperative Pain Measure
Time frame: 7 days
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
Plan to share: No
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McGill University Health Centre/Research Institute of the McGill University Health Centre