- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04188431
Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children (Blueberry)
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
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Walid Habre, MD, PhD
- Phone Number: +41223727504
- Email: walid.habre@unige.ch
Study Contact Backup
- Name: Beatrice Gil-Wey, RN
- Phone Number: +41795532377
- Email: beatrice.gil-wey@hcuge.ch
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, QC H4A 3L5
- Not yet recruiting
- Queen Elizabeth Hospital of Montreal, Mc Gill
-
Contact:
- Thomas ENGELHARDT, MD
- Email: tomkat01@yahoo.com
-
Contact:
- Cajetan N Fobisong, MSc, CRC, CRA, MLA
- Phone Number: 22464 0015144124400
- Email: cajetannkong.fobisong@muhc.mcgill.ca
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-
-
-
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Geneva, Switzerland, 1205
- Recruiting
- Geneva Children's Hospital
-
Contact:
- Walid HABRE, MD, PhD
-
Contact:
- Isabelle Pichon, RN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Signs and Symptoms, Digestive
- Nausea
- Pain, Postoperative
- Vomiting
- Hemorrhage
- Postoperative Nausea and Vomiting
- Postoperative Hemorrhage
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- 2019-02268
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
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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