Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

523 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2024-03-01

Brief Summary

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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.

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Detailed Description

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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

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Pain, Postoperative Tonsillar Bleeding Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind (investigator-surgeon-patient blinded), randomized, placebo control, multi-centre, international, pragmatic, Non-inferiority trial.

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Dexamethasone

Single intraoperative administration of 0.15 mg/kg of Dexamethasone intravenously with a maximum dose of 5 mg

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Is usually commercialized as dexamethasone phosphate as solution for injection

Sodium chloride

Single intraoperative administration of Sodium Chloride (NaCl) 0.9% intravenously

Group Type PLACEBO_COMPARATOR

Sodium chloride

Intervention Type DRUG

prepared in the same intravenous volume to mimic experimental arm

Interventions

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Dexamethasone

Is usually commercialized as dexamethasone phosphate as solution for injection

Intervention Type DRUG

Sodium chloride

prepared in the same intravenous volume to mimic experimental arm

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

2 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No