Comparison of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting (PONV) in Children
NCT ID: NCT01434017
Last Updated: 2014-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2008-11-30
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic antiemetic treatments:
* dexamethasone alone (250 mcg/kg)
* dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg)
* dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Administration of Dexamethasone in PONV Prophylaxis in Children Undergoing Adenotomy
NCT03398044
Dexamethasone Versus Local Infiltration Technique for Tonsillectomy in Children
NCT02355678
The Effects of IV vs Oral Dexamethasone on Postoperative Nausea, Vomiting, and Pain
NCT04563494
Effect of Intravenous Fentanyl on the Occurrence of Postoperative Nausea and Vomiting According to Time of Administration Around the End of Tonsillectomy With or Without Adenoidectomy
NCT03343002
Dexamethasone for Paediatric Adeno-tonsillectomy - A Dose-finding Study
NCT00403806
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic antiemetic treatments:
* dexamethasone alone (250 mcg/kg)
* dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg)
* dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).
The hypothesis is that the combination of dexamethasone and droperidol is as effective as the combination of dexamethasone and ondansetron, both of them being more effective than dexamethasone alone. Moreover, droperidol is cheaper than ondansetron and may be recommended as a first-line treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dexamethasone
Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.
Dexamethasone
Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.
Dexamethasone and Droperidol
Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.
Dexamethasone and droperidol
Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.
Dexamethasone and Ondansetron
Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.
Dexamethasone and Ondansetron
Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexamethasone
Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.
Dexamethasone and droperidol
Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.
Dexamethasone and Ondansetron
Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* children ASA 1-2
* weight \> 15 kg
* tonsillectomy with or without adenoidectomy
Exclusion Criteria
* contraindication to steroids
* contraindication to antidopaminergic drugs
* contraindication to serotoninergic antagonists
* administration of steroids, antidopaminergic drugs, or serotoninergic antagonists in the 24 hours before the surgery
* refusal of parents
* no-french speaking parents
2 Years
10 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire Vaudois
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eric Albrecht
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eric Albrecht
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire Vaudois
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Hospitalier Universitaire Vaudois and University of Lausanne
Lausanne, Canton of Vaud, Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHUV-51-08
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.