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Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children (Blueberry)

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ClinicalTrials.gov Identifier: NCT04188431
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : October 1, 2021
University Hospital, Geneva
Information provided by (Responsible Party):
Walid HABRE, 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Tonsillar Bleeding Postoperative Nausea and Vomiting Drug: Dexamethasone Drug: Sodium chloride Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3794 participants
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.
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.

Primary Purpose: Other
Official Title: Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children: Double-blind, Randomized, Placebo Control, Multi-centre, International, Pragmatic, Non-inferiority Trial
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : October 1, 2023

Arm Intervention/treatment
Experimental: Dexamethasone
Single intraoperative administration of 0.15 mg/kg of Dexamethasone intravenously with a maximum dose of 5 mg
Drug: Dexamethasone
Is usually commercialized as dexamethasone phosphate as solution for injection

Placebo Comparator: Sodium chloride
Single intraoperative administration of Sodium Chloride (NaCl) 0.9% intravenously
Drug: Sodium chloride
prepared in the same intravenous volume to mimic experimental arm

Primary Outcome Measures :
  1. Reoperation for postoperative bleeding [ Time Frame: Up to 30 days ]
    bleeding requiring surgical revision

Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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

  4. 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

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Ages Eligible for Study:   2 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04188431

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Contact: Walid Habre, MD, PhD +41223727504 walid.habre@unige.ch
Contact: Beatrice Gil-Wey, RN +41795532377 beatrice.gil-wey@hcuge.ch

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Canada, Quebec
Queen Elizabeth Hospital of Montreal, Mc Gill Not yet recruiting
Montreal, Quebec, Canada, QC H4A 3L5
Contact: Thomas ENGELHARDT, MD       tomkat01@yahoo.com   
Contact: Cajetan N Fobisong, MSc, CRC, CRA, MLA    0015144124400 ext 22464    cajetannkong.fobisong@muhc.mcgill.ca   
geneva Children's Hospital Recruiting
Geneva, Switzerland, 1205
Contact: Walid HABRE, MD, PhD         
Contact: Isabelle Pichon, RN         
Sponsors and Collaborators
University Hospital, Geneva
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Responsible Party: Walid HABRE, Professor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT04188431    
Other Study ID Numbers: 2019-02268
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Walid HABRE, University Hospital, Geneva:
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Nausea and Vomiting
Postoperative Hemorrhage
Pathologic Processes
Signs and Symptoms, Digestive
Postoperative Complications
Neurologic Manifestations
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents