Pain, PostoperativePhase 4BlueberryNCT04188431
Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children
A Phase 4 study testing Dexamethasone and Sodium chloride in people with Pain, Postoperative and Tonsillar Bleeding, run by Walid HABRE at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 2 to 13 years
- Conditions the study is for
- Pain, Postoperative, Tonsillar Bleeding, Postoperative Nausea and Vomiting
- What is being tested?
- Dexamethasone and Sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 523 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Nov 2020to 1 Mar 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Children under Aspirin or any other anticoagulants with or without Congenital Heart Disease
- Children with any bleeding disorders (ex. Haemophilia, Von Willebrand Disease)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Canada1 site
Queen Elizabeth Hospital of Montreal, Mc Gill
Montreal, Quebec, QC H4A 3L5
About this study
Official title: 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.
Read the 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.
- Being tested
- Dexamethasone, Sodium chloride
- Keywords
- reintervention, children
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Is usually commercialized as dexamethasone phosphate as solution for injection
Sodium chlorideDrug
prepared in the same intravenous volume to mimic experimental arm
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Single intraoperative administration of 0.15 mg/kg of Dexamethasone intravenously with a maximum dose of 5 mg Receives: Drug: Dexamethasone |
| Sodium chloride | Placebo comparator | Single intraoperative administration of Sodium Chloride (NaCl) 0.9% intravenously Receives: Drug: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation for postoperative bleeding
bleeding requiring surgical revision
Measured: Up to 30 days
Secondary outcomes (4)
Respiratory complications
- Incidence of perioperative respiratory critical events: laryngospasm, bronchospasm, stridor, bronchial aspiration, hypoxia (Saturation in oxygen<90% for 2 minutes)
Measured: Intraoperative and up to 2 hours postoperative
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.
Measured: Up to 7 days after surgery
Postoperative nausea, vomiting and retching
- Number of postoperative nausea and vomiting (PONV) and retching: during the stay at hospital with a maximum of 24 hours post-extubation
Measured: 3 intervals: 0-2 hours, 2-6 hours and 6-24 hours postoperatively
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
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Nov 2020
- Primary completion30 Mar 2023
- Study completion1 Mar 2024
Why it stopped: Lack of finance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind (investigator-surgeon-patient blinded), randomized, placebo control, multi-centre, international, pragmatic, Non-inferiority trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 523 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walid HABRE
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor-investigator, Walid HABRE, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188431
- Sponsor's protocol ID
- 2019-02268
- Other IDs
- 2019
- Acronym
- Blueberry
- Status last verified
- Apr 2024
- First submitted
- 1 Dec 2019
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone and Postoperative Bleeding Following Tonsillectomy in Children: Double-blind, Randomized, Placebo Control, Multi-centre, International, Pragmatic, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04188431
- Acronym / sponsor ID
- Blueberry / 2019-02268
- Keywords
- reintervention, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of finance
- Enrolment
- 523 participants (actual)
- Lead sponsor
- Walid HABREUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind (investigator-surgeon-patient blinded), randomized, placebo control, multi-centre, international, pragmatic, Non-inferiority trial.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneSingle intraoperative administration of 0.15 mg/kg of Dexamethasone intravenously with a maximum dose of 5 mg |
| Sodium chloride | Placebo comparator | Drug: Sodium chlorideSingle intraoperative administration of Sodium Chloride (NaCl) 0.9% intravenously |
Who may qualify
- Ages
- 2 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Children under Aspirin or any other anticoagulants with or without Congenital Heart Disease
- Children with any bleeding disorders (ex. Haemophilia, Von Willebrand Disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneIs usually commercialized as dexamethasone phosphate as solution for injection | Drug | Dexamethasone |
| Sodium chlorideprepared in the same intravenous volume to mimic experimental arm | Drug | Sodium chloride |
Primary outcome
Reoperation for postoperative bleeding
Time frame: Up to 30 days
bleeding requiring surgical revision
4 secondary outcomes
Respiratory complications
Time frame: Intraoperative and up to 2 hours postoperative
Pain scores
Time frame: 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
Morbidity
Time frame: Up to 30 days
Results and safety
The study was stopped early (reason given: Lack of finance). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Sodium chloride in people with Pain, Postoperative and Tonsillar Bleeding, run by Walid HABRE at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of finance). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reoperation for postoperative bleeding (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.