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Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children

NCT04188431 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 523

Last updated 2024-04-18

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • University Hospital, Geneva

    collaborator OTHER

  • Walid HABRE

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Canada
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04188431 on ClinicalTrials.gov