NCT04188431

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 523 (actual)
• Sponsor: Walid HABRE · Academic / Other
• Sex: All
• Age: 2 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative
• Tonsillar Bleeding
• Postoperative Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Dexamethasone	Is usually commercialized as dexamethasone phosphate as solution for injection
DRUG	Sodium chloride	prepared in the same intravenous volume to mimic experimental arm

Timeline

• Start date: 2020-11-01
• Primary completion: 2023-03-30
• Completion: 2024-03-01
• First posted: 2019-12-05
• Last updated: 2024-04-18

Locations

2 sites across 2 countries: Canada, Switzerland