Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children

NCT04188431 | Terminated Phase 4 DMC

• 1 other identifier: 2019-02268
• Study Type: interventional
• Target: 523
• Locations: 2 countries
• Sites: 2

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.

Conditions

Pain, Postoperative; Tonsillar Bleeding; Postoperative Nausea and Vomiting

Keywords

reintervention; children

Outcome Measures

Primary Outcomes (1)

• Reoperation for postoperative bleeding

  bleeding requiring surgical revision

  Up to 30 days

Secondary Outcomes (4)

• 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

Study Arms (2)

Dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone

Sodium chloride

PLACEBO COMPARATOR

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

Drug: Sodium chloride

Interventions

Dexamethasone DRUG

Is usually commercialized as dexamethasone phosphate as solution for injection

Dexamethasone

Sodium chloride DRUG

prepared in the same intravenous volume to mimic experimental arm

Sodium chloride

Eligibility Criteria

• Age: 2 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children under Aspirin or any other anticoagulants with or without Congenital Heart Disease
• Children with any bleeding disorders (ex. Haemophilia, Von Willebrand Disease)

Sponsors & Collaborators

• Walid HABRE: lead
• University Hospital, Geneva: collaborator

Study Sites (2)

Queen Elizabeth Hospital of Montreal, Mc Gill

Montreal, Quebec, QC H4A 3L5, Canada

Location

geneva Children's Hospital

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: December 5, 2019
• Study Start: November 1, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 1, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Up to 2 years following study completion
• 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

Locations

CH (1); CA (1)