Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children

Pain, Postoperative Clinical Trial

— Blueberry  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04188431
• Other study ID #: 2019-02268
• Status: Terminated
• Phase: Phase 4
• Start date: November 1, 2020
• Est. completion date: March 1, 2024

Study information

• Verified date: April 2024
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 523
• Est. completion date: March 1, 2024
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 13 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hemorrhage
• Pain, Postoperative
• Postoperative Hemorrhage
• Postoperative Nausea and Vomiting
• Tonsillar Bleeding
• Vomiting

Intervention

Drug:
• Dexamethasone
Is usually commercialized as dexamethasone phosphate as solution for injection
• Sodium chloride
prepared in the same intravenous volume to mimic experimental arm

Locations

Country	Name	City	State
Canada	Queen Elizabeth Hospital of Montreal, Mc Gill	Montreal	Quebec
Switzerland	geneva Children's Hospital	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Walid HABRE	University Hospital, Geneva

Countries where clinical trial is conducted

Canada,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation for postoperative bleeding	bleeding requiring surgical revision	Up to 30 days
Secondary	Respiratory complications	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
Secondary	Pain scores	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
Secondary	Postoperative nausea, vomiting and retching	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
Secondary	Morbidity	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