Pain, Postoperative, Postoperative Nausea and Vomiting, Tonsillar Bleeding
Conditions
Keywords
reintervention, children
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.
Interventions
DRUGDexamethasone
Is usually commercialized as dexamethasone phosphate as solution for injection
DRUGSodium chloride
prepared in the same intravenous volume to mimic experimental arm
Sponsors
University Hospital, Geneva
Walid HABRE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
Double-blind (investigator-surgeon-patient blinded), randomized, placebo control, multi-centre, international, pragmatic, Non-inferiority trial.
Eligibility
Sex/Gender
ALL
Age
2 Years to 13 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation for postoperative bleeding | Up to 30 days | bleeding requiring surgical revision |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
Countries
Canada, Switzerland
Outcome results
None listed