drugset / Trial / NCT04188431

Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children

NCT04188431 ↗

Phase 4 Terminated 523 enrolled Walid HABRE University Hospital, Geneva · collab
RandomizedParallel-groupQuadruple-blindOther

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.

Timeline

Start
2020-11-01
Primary completion
2023-03-30
Completion
2024-03-01

Outcome

Outcome not reported

Stopped (Business): “Lack of finance”

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 0.15 mg/kg Intravenous