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Opioid-sparing Effect of Intranasal Dexmedetomidine

NCT05848505 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-05-08

No results posted yet for this study

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.

Conditions

  • Tonsillar Hypertrophy

Interventions

DRUG

Dexmedetomidine

Intranasal administration Dosage 2 mcg/kg

Sponsors & Collaborators

  • Pierre-Yves P Lequeux

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-25
Primary Completion
2022-12-20
Completion
2022-12-20

Countries

  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05848505 on ClinicalTrials.gov