Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children (Blueberry)

Walid HABRE

Status and phase: Terminated; Phase 4

Conditions: Postoperative Nausea and Vomiting; Pain, Postoperative; Tonsillar Bleeding

Treatments: Drug: Dexamethasone; Drug: Sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04188431

2019-02268

Details and patient eligibility

About

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.

Full 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.

Enrollment: 523 patients

Sex: All

Ages: 2 to 13 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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523 participants in 2 patient groups, including a placebo group

Dexamethasone

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone

Sodium chloride

Placebo Comparator group

Description:

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

Treatment:

Drug: Sodium chloride