Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children
Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children: Double-blind, Randomized, Placebo Control, Multi-centre, International, Pragmatic, Non-inferiority Trial
Lead Sponsor: Walid HABRE
Collaborator: University Hospital, Geneva
|Source||University Hospital, Geneva|
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.
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.
|Overall Status||Not yet recruiting|
|Start Date||June 1, 2020|
|Completion Date||October 1, 2023|
|Primary Completion Date||June 30, 2023|
Intervention Type: Drug
Intervention Name: Dexamethasone
Description: Is usually commercialized as dexamethasone phosphate as solution for injection
Arm Group Label: Dexamethasone
Intervention Type: Drug
Intervention Name: Sodium chloride
Description: prepared in the same intravenous volume to mimic experimental arm
Arm Group Label: Sodium chloride
Inclusion Criteria: - Children aged from 2 to 16 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)
- Children aged from 2 to 16 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
- Children under Aspirin or any other anticoagulants with or without Congenital Heart Disease
- Children with any bleeding disorders (ex. Haemophilia, Von Willebrand Disease)
Minimum Age: 2 Years
Maximum Age: 16 Years
Healthy Volunteers: No
Last Name: Walid Habre, MD, PhD
Email: [email protected]
Investigator Affiliation: University Hospital, Geneva
Investigator Full Name: Walid HABRE
Investigator Title: Professor
|Has Expanded Access||No|
|Number Of Arms||2|
Description: Single intraoperative administration of 0.15 mg/kg of Dexamethasone intravenously with a maximum dose of 5 mg
Label: Sodium chloride
Type: Placebo Comparator
Description: Single intraoperative administration of Sodium Chloride (NaCl) 0.9% intravenously
|Study Design Info||
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind (investigator-surgeon-patient blinded), randomized, placebo control, multi-centre, international, pragmatic, Non-inferiority trial.
Primary Purpose: Other
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Patients are allocated by block randomisation using sealed envelope system. An external person dedicated by Sponsor is in charge to randomize groups of treatment allocation through a website-generated list and to conceal the lists. Each centre receives the sealed opaque envelopes which contain treatment allocation. The envelope will be opened just before surgery. A member of the team not involved in the anaesthesia care will open an envelope and prepare the tested medication according to the result of randomization (Dexamethasone or NaCl). The repartition ratio between the 2 arms is 1:1 with a block size of 10.