Dexamethasone and postoperative bleeding following tonsillectomy in childre

Phase 1

Conditions: Tonsillectomy/tonsillotomy
Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

Registration Number: EUCTR2021-001425-48-BE

Lead Sponsor: Division of Anaesthesiology - Department of Acute Medicine - Geneva Children's Hospital, University Hospitals of Geneva

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 3794

Inclusion Criteria

? Children aged from 2 to 13 years of age inclusive admitted for
tonsillectomy/ tonsillotomy
? Parents or legal responsible person willing and capable to follow data
collection by the application (Android and iPhone) developed for this study

Are the trial subjects under 18? yes
Number of subjects for this age range: 3794
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Children under Aspirin or any other anticoagulants with or without
Congenital Heart Disease
? Children with any bleeding disorders (ex. Haemophilia, Von Willbrand
Disease)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective: to provide evidence of the Dexamethasone safety profile <br>with regard to the risk of post-tonsillectomy bleeding in children when <br>administered as a single intraoperative dose of 0.15mg/kg. <br><br>;Secondary Objective: Secondary objective: to characterize whether the co-administration of NSAIDs <br>for analgesia potentiates the risk of postoperative haemorrhage.;Primary end point(s): Incidence of postoperative haemorrhage requiring re-operation within 30 <br>days following tonsillectomy with or without adenoidectomy<br>;Timepoint(s) of evaluation of this end point: 30 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Association between Dexamethasone use and increased/decreased <br>incidence of : Perioperative respiratory critical events <br>Postoperative nausea and vomiting during stay at hospital with a maximum <br>of 24 hours post-extubation<br>Postoperative analgesia request (Opioids 2h post-extubation)<br>NSAIDs need during 7 days following surgery<br>Pain scores during 7 days following surgery<br>Re-admission for consultation in the case of bleeding during 30 days<br>Medical consultation outside of programmed postoperative control at any <br>institution<br>Morbidity and mortality at 30 days after surgery<br>;Timepoint(s) of evaluation of this end point: 24 hours postop<br>2 hours post-extubation<br>7days postop<br>30 days postop