Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children

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

Sponsors

Lead Sponsor: Walid HABRE

Collaborator: University Hospital, Geneva

Source University Hospital, Geneva
Brief 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.

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.

Overall Status Not yet recruiting
Start Date June 1, 2020
Completion Date October 1, 2023
Primary Completion Date June 30, 2023
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Reoperation for postoperative bleeding Up to 30 days
Secondary Outcome
Measure Time Frame
Respiratory complications Intraoperative and up to 2 hours postoperative
Pain scores Up to 7 days after surgery
Postoperative nausea, vomiting and retching 3 intervals: 0-2 hours, 2-6 hours and 6-24 hours postoperatively
Morbidity Up to 30 days
Enrollment 3794
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dexamethasone

Description: Is usually commercialized as dexamethasone phosphate as solution for injection

Arm Group Label: Dexamethasone

Intervention Type: Drug

Intervention Name: Sodium chloride

Description: prepared in the same intravenous volume to mimic experimental arm

Arm Group Label: Sodium chloride

Eligibility

Criteria:

Inclusion Criteria:

- Children aged from 2 to 16 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)

Gender: All

Minimum Age: 2 Years

Maximum Age: 16 Years

Healthy Volunteers: No

Overall Contact

Last Name: Walid Habre, MD, PhD

Phone: +41223727504

Email: [email protected]

Verification Date

April 2020

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: University Hospital, Geneva

Investigator Full Name: Walid HABRE

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Dexamethasone

Type: Experimental

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

Label: Sodium chloride

Type: Placebo Comparator

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

Acronym Blueberry
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

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

Primary Purpose: Other

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: 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.

Source: ClinicalTrials.gov