Opioid-sparing Effect of Intranasal Dexmedetomidine
Status:
Completed
Trial end date:
2022-12-20
Target enrollment:
Participant gender:
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.