Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children

Phase 4

Terminated

• Conditions: Pain, Postoperative; Tonsillar Bleeding; Postoperative Nausea and Vomiting
• Interventions: Drug: Sodium chloride; Drug: Dexamethasone

• Registration Number: NCT04188431
• Lead Sponsor: Walid HABRE

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.

Study Timeline

• Study First Submitted: 2019-12-01
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Study Start: 2020-11-01
• Primary Completion: 2023-03-30
• Study Completion: 2024-03-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 523

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium chloride	Sodium chloride	Single intraoperative administration of Sodium Chloride (NaCl) 0.9% intravenously
Dexamethasone	Dexamethasone	Single intraoperative administration of 0.15 mg/kg of Dexamethasone intravenously with a maximum dose of 5 mg

Primary Outcome Measures

Name	Time	Method
Reoperation for postoperative bleeding	Up to 30 days	bleeding requiring surgical revision

Secondary Outcome Measures

Name	Time	Method
Respiratory complications	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)
Pain scores	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.
Morbidity	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
Postoperative nausea, vomiting and retching	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

Trial Locations

Locations (2)

Queen Elizabeth Hospital of Montreal, Mc Gill; 🇨🇦 Montreal, Quebec, Canada

geneva Children's Hospital; 🇨🇭 Geneva, Switzerland