Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children (Blueberry)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04188431|
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : October 1, 2021
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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3794 participants|
|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)|
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.
|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|
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
Drug: Sodium chloride
prepared in the same intravenous volume to mimic experimental arm
- Reoperation for postoperative bleeding [ Time Frame: Up to 30 days ]bleeding requiring surgical revision
- 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)
- 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.
- 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
- 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
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
|Contact: Walid Habre, MD, PhDemail@example.com|
|Contact: Beatrice Gil-Wey, RNfirstname.lastname@example.org|
|Queen Elizabeth Hospital of Montreal, Mc Gill||Not yet recruiting|
|Montreal, Quebec, Canada, QC H4A 3L5|
|Contact: Thomas ENGELHARDT, MD email@example.com|
|Contact: Cajetan N Fobisong, MSc, CRC, CRA, MLA 0015144124400 ext 22464 firstname.lastname@example.org|
|geneva Children's Hospital||Recruiting|
|Geneva, Switzerland, 1205|
|Contact: Walid HABRE, MD, PhD|
|Contact: Isabelle Pichon, RN|