Postoperative Nausea and VomitingPhase 4NCT01434017
Comparison of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting (PONV) in Children
A Phase 4 study testing Dexamethasone, Dexamethasone and droperidol and Dexamethasone and Ondansetron in people with Postoperative Nausea and Vomiting, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Incidence of postoperative nausea and vomiting (PONV) in children after tonsillectomy with or without adenoidectomy may be as high as 75%. Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and serotonin (5-HT3) antagonists. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Dexamethasone, Dexamethasone and droperidol and Dexamethasone and Ondansetron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2008to Jun 2013
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 2-10 y.
- children ASA 1-2
- weight > 15 kg
- tonsillectomy with or without adenoidectomy
Who cannot join
- intravenous induction
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois and University of Lausanne
Lausanne, Canton of Vaud, 1011
About this study
Official title: Comparison of Three Different Prophylactic Treatments of PONV in Children
Incidence of postoperative nausea and vomiting (PONV) in children after tonsillectomy with or without adenoidectomy may be as high as 75%.
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).
Read the detailed description
Tonsillectomy with or without adenoidectomy may be associated with severe postoperative nausea and vomiting (PONV). Causes are principally trigeminal nerve stimulation and presence of blood in the stomach. Consequences are disagreement, unsatisfactory, delayed discharge, and overnight admission in day-cases. More barely, patients may also have suture and esophagus rupture, aspiration of gastric contents, dehydration and electrolyte disturbances.
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
- Postoperative Nausea and Vomiting
- Being tested
- Dexamethasone, Dexamethasone and droperidol, Dexamethasone and Ondansetron
- Keywords
- PONV, Dexamethasone, Droperidol, Ondansetron, Tonsillectomy
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.
Dexamethasone and droperidolDrug
Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.
Dexamethasone and OndansetronDrug
Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia. Receives: Drug: Dexamethasone |
| Dexamethasone and Droperidol | Active comparator | Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia. Receives: Drug: Dexamethasone and droperidol |
| Dexamethasone and Ondansetron | Active comparator | Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia. Receives: Drug: Dexamethasone and Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PONV after tonsillectomy with or without adenoidectomy
Measured: 48 hours
Secondary outcomes (1)
Incidence of side effects (extrapyramidal syndrome, hemorrhage, somnolence, headaches)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startNov 2008
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
- Investigators
- Eric Albrecht, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434017
- Sponsor's protocol ID
- CHUV-51-08
- Status last verified
- Feb 2014
- First submitted
- 13 Sep 2011
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Different Prophylactic Treatments of PONV in Children
- ClinicalTrials.gov ID
- NCT01434017
- Acronym / sponsor ID
- CHUV-51-08
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- PONV, Dexamethasone, Droperidol, Ondansetron, Tonsillectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 Sep 2011 (estimated)
- 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.
Incidence of postoperative nausea and vomiting (PONV) in children after tonsillectomy with or without adenoidectomy may be as high as 75%.
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).
Detailed description
Tonsillectomy with or without adenoidectomy may be associated with severe postoperative nausea and vomiting (PONV). Causes are principally trigeminal nerve stimulation and presence of blood in the stomach. Consequences are disagreement, unsatisfactory, delayed discharge, and overnight admission in day-cases. More barely, patients may also have suture and esophagus rupture, aspiration of gastric contents, dehydration and electrolyte disturbances.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: DexamethasonePatients will receive dexamethasone 250 mcg/kg just after induction of anesthesia. |
| Dexamethasone and Droperidol | Active comparator | Drug: Dexamethasone and droperidolPatients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia. |
| Dexamethasone and Ondansetron | Active comparator | Drug: Dexamethasone and OndansetronPatients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children aged 2-10 y.
- children ASA 1-2
- weight > 15 kg
- tonsillectomy with or without adenoidectomy
Key exclusion criteria (7 listed)
- intravenous induction
- 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
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 |
|---|---|---|
| DexamethasonePatients will receive dexamethasone 250 mcg/kg just after induction of anesthesia. | Drug | Dexamethasone |
| Dexamethasone and droperidolPatients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia. | Drug | Dexamethasone and Droperidol |
| Dexamethasone and OndansetronPatients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia. | Drug | Dexamethasone and Ondansetron |
Primary outcome
Incidence of PONV after tonsillectomy with or without adenoidectomy
Time frame: 48 hours
1 secondary outcome
Incidence of side effects (extrapyramidal syndrome, hemorrhage, somnolence, headaches)
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
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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.
Eric Albrecht principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone, Dexamethasone and droperidol and Dexamethasone and Ondansetron in people with Postoperative Nausea and Vomiting, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of PONV after tonsillectomy with or without adenoidectomy (time frame: 48 hours). 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 27 Feb 2014.