Opioid-sparing Effect of Intranasal Dexmedetomidine

• Status: Completed
• Trial end date: 2022-12-20
• Target enrollment: 0
• Participant gender: All

Summary

Background: Management of postoperative pain in paediatric patients undergoing tonsillectomy remains a challenge that faces anesthesiologists in their daily practice. High dose of opioids are usually necessary and are responsible for side effects like nausea, vomiting, constipation, delayed hospital discharge and more importantly respiratory depression and sleep apnea. Dexmedetomidine is a selective alpha two agonist that has an analgesic and anxiolytic effect with minimal effects on respiratory drive.

Goal of the study: The aim of this study is to assess the opioid sparing effect of preoperative intranasal dexmedetomidine as part of multimodal analgesia in the paediatric population undergoing tonsillectomy.

Methods: This will be a prospective, randomised, controlled, double blinded clinical trial with 50 participants who will be randomised between two groups: dexmedetomidine group and control group. The dexmedetomidine group will receive intranasal dexmedetomidine in the preoperative holding area while the other group will receive the placebo.

The primary endpoint will be the total fentanyl consumption in the perioperative period. Additionally, we will look at postoperative pain scores at 10, 30 and 60 minutes after recovery as well as the time to first opioid rescue analgesic and agitation scores as secondary endpoints. Blood pressure and hart rate will also be recorded throughout the study period.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre-Yves P Lequeux
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• Patients undergoing elective tonsillectomy

Exclusion Criteria:

• documented allergy to dexmedetomidine, paracetamol, ondansetron or dexamethasone

• hepatic dysfunction

• raised intracranial pressure or altered GCS

• neuromuscular disease.