Clinical trial NCT04188431: Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children
Official title: Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children: Double-blind, Randomized, Placebo Control, Multi-centre, International, Pragmatic, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain, Postoperative
Tonsillar Bleeding
Postoperative Nausea and Vomiting
Keywords: reintervention
children
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
First posted: 2019-12-05
Enrollment: 523
Sex: ALL
Minimum age (years): 2
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind (investigator-surgeon-patient blinded), randomized, placebo control, multi-centre, international, pragmatic, Non-inferiority trial.
Primary purpose: OTHER

Brief summary: Tonsillectomy is one of the most frequently performed surgical interventions in children. However, it is associated with a high incidence of PostOperative Nausea and Vomiting (PONV), severe pain and haemorrhage.

There is strong evidence on the efficacy of Dexamethasone in reducing the incidence of PONV and pain after tonsillectomy, which led to consider this drug as a first line treatment in routine anaesthesia practice in such surgical setting. However, in the last decade, there have been arguments about the potential role of Dexamethasone in increasing the risk of postoperative bleeding in children and studies addressing the haemorrhage risk following administration of Dexamethasone for tonsillectomy are inconclusive.Thus, this study is aimed at providing evidence for the safety profile of Dexamethasone with regard to the risk of post-tonsillectomy bleeding in children when administered as a single intraoperative dose.

Detailed description: This double-blind (investigator-surgeon-patient blinded), randomized, placebo control, multicentre, international, pragmatic, non-inferiority trial is designed to to provide evidence of the Dexamethasone safety profile with regard to the risk of post-tonsillectomy bleeding in children when administered as a single intraoperative dose of 0.15mg/kg. The study is also aimed at characterizing whether the co-administration of non steroidal anti-inflammatory drugs for analgesia potentiates the risk of postoperative haemorrhage.

Sample size estimation is based on the definition of a minimal clinically important difference between the 2 groups of treatment (dexamethasone or normal saline) to be equal to 2% (non-inferiority margin). Thus, 3'794 children in total will be included with 1'897 children in each treatment group.

The follow-up will be performed by the parents via an "Application" for Android and Apple that has been developed specifically for this study.

Eligibility criteria: Inclusion Criteria:

* Children aged from 2 to 13 years admitted for tonsillectomy/ tonsillotomy with or without adenoidectomy
* Parents or legal responsible person willing and capable to follow data collection by the application (Android and iPhone) developed for this study

Exclusion Criteria:

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

Primary outcomes:
measure: Reoperation for postoperative bleeding
timeFrame: Up to 30 days
Secondary outcomes:
measure: Respiratory complications
timeFrame: Intraoperative and up to 2 hours postoperative
measure: Pain scores
timeFrame: Up to 7 days after surgery
measure: Postoperative nausea, vomiting and retching
timeFrame: 3 intervals: 0-2 hours, 2-6 hours and 6-24 hours postoperatively
measure: Morbidity
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Queen Elizabeth Hospital of Montreal, Mc Gill
state: Quebec
city: Geneva
country: Switzerland
facility: geneva Children's Hospital
Study officials:
References: