Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children (Blueberry)

September 30, 2021 updated by: Walid HABRE

Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children: Double-blind, Randomized, Placebo Control, Multi-centre, International, Pragmatic, Non-inferiority Trial

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

3794

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Quebec
      • Montreal, Quebec, Canada, QC H4A 3L5
      • Geneva, Switzerland, 1205
        • Recruiting
        • Geneva Children's Hospital
        • Contact:
          • Walid HABRE, MD, PhD
        • Contact:
          • Isabelle Pichon, RN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone
Single intraoperative administration of 0.15 mg/kg of Dexamethasone intravenously with a maximum dose of 5 mg
Is usually commercialized as dexamethasone phosphate as solution for injection
Placebo Comparator: Sodium chloride
Single intraoperative administration of Sodium Chloride (NaCl) 0.9% intravenously
prepared in the same intravenous volume to mimic experimental arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation for postoperative bleeding
Time Frame: Up to 30 days
bleeding requiring surgical revision
Up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory complications
Time Frame: Intraoperative and up to 2 hours postoperative
7) Incidence of perioperative respiratory critical events: laryngospasm, bronchospasm, stridor, bronchial aspiration, hypoxia (Saturation in oxygen<90% for 2 minutes)
Intraoperative and up to 2 hours postoperative
Pain scores
Time Frame: Up to 7 days after surgery
Assessment of pain scores at the hospital with the total score for the FLACC (Face, Legs, Activity, Cry, Consolability) scale for children less than 2 years of age and by the numeric pain rating scale above. Then at home, assessment by parents with the short version of the parents postoperative pain measurement.
Up to 7 days after surgery
Postoperative nausea, vomiting and retching
Time Frame: 3 intervals: 0-2 hours, 2-6 hours and 6-24 hours postoperatively
2) Number of postoperative nausea and vomiting (PONV) and retching: during the stay at hospital with a maximum of 24 hours post-extubation
3 intervals: 0-2 hours, 2-6 hours and 6-24 hours postoperatively
Morbidity
Time Frame: Up to 30 days
Any admission to high dependency unit or ICU, readmission for following reasons: Ear, Nose and Throat infection, dehydration, pulmonary infection, other pulmonary complications, seizure or bleeding not requiring reoperation
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

December 1, 2019

First Submitted That Met QC Criteria

December 3, 2019

First Posted (Actual)

December 5, 2019

Study Record Updates

Last Update Posted (Actual)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available

IPD Sharing Time Frame

Up to 2 years following study completion

IPD Sharing Access Criteria

Data access requests from National coordinators or from local investigators will be examined by the steering committee and an agreement will be signed prior to Data access

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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