Postoperative VomitingVPOP2NCT01739985
Postoperative Vomiting in Children: Comparison Tri - Versus bi -Prophylaxis
A study testing Dexamethasone + ondansetron + Droperidol in people with Postoperative Vomiting, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate the benefit of addition of droperidol to prophylaxis with ondansetron and dexamethasone in children with high risk of postoperative vomiting (POV). Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Postoperative Vomiting
- What is being tested?
- Dexamethasone + ondansetron + Droperidol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 322 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to May 2014
- Phase
- Interventional
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children scheduled for surgery and with high risk of postoperative vomiting, i.e. with VPOP score up to 4
- Between 3 to 18 years
- Informed consent signed or the owner (s) of parental
- Children receiving a social security system
Who cannot join
- Ambulatory surgery
- Preoperative corticosteroids
- Postoperative sedation
- Allergy known to droperidol, ondansetron or dexamethasone
- Known hypokaliemia
- Known hypomagnesemia
Show all 11Show fewer
- Bradycardia (<55 bpm)
- Congenital long QT syndrome
- Treatment that induce prolonged QT
- Pheochromocytoma
- Severe depressive syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Vomiting in Children: Evaluation of the Addition of Droperidol to Conventional Bi-prophylaxis
The purpose of this study is to evaluate the benefit of addition of droperidol to prophylaxis with ondansetron and dexamethasone in children with high risk of postoperative vomiting (POV). In adults some authors showed that the effectiveness of prophylaxis is correlated to the number of molecules or specific procedures used.
Read the detailed description
The overall incidence of postoperative vomiting between 25 and 30% for the pediatric population, but it can reach a much higher incidence associated with certain types of surgery, about 80% in some studies like strabismus surgery for example. The identification of patients at high risk of POV is possible through the use of risk score. It is currently only one pediatric validated risk score, but the investigators conducted a multicenter study on this subject, whose results are being analyzed. This should allow us to identify children at high risk of POV. In this targeted population, the prophylaxis should allow a significant reduction in the incidence of POV. In children only one study tried to evaluate the association of ondansetron, dexamethasone and droperidol to prevent postoperative vomiting. However, different doses of the different molecules were combined, the extremely complicated design of this study and important methodological bias do not provide evidence about the superiority of the combination of three anti-emetics compared with two anti-emetics. Our present randomized, double-blind study is designed to compare the effectiveness of Droperidol in combination with a conventional bi-prophylaxis (dexamethasone/ondansetron) to the conventional bi-prophylaxis alone to decrease the occurrence of postoperative vomiting in children at high risk. The combination ondansetron and dexamethasone is frequently assessed as an association to prevent postoperative vomiting also in the adult population and in the pediatric population.
- Conditions
- Postoperative Vomiting
- Being tested
- Dexamethasone + ondansetron + Placebo, Dexamethasone + ondansetron + Droperidol
- Keywords
- Postoperative, Vomiting, Children, Prophylaxis, Droperidol, Ondansetron, Dexamethasone
- Medical subject headings
- Postoperative Nausea and Vomiting, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone + ondansetron + PlaceboDrug
Administration of ondansetron and dexamethasone immediately after induction of anesthesia. Ondansetron is administered at a dose of 100 micrograms.kg-1, dexamethasone at a dose of 125 microg x kg-1.Administration of the saline 30 minutes before the end of surgery
Dexamethasone + ondansetron + DroperidolDrug
Administration of ondansetron and dexamethasone immediately after induction of anesthesia. Ondansetron is administered at a dose of 100 micrograms.kg-1, dexamethasone at a dose of 125 microg x kg-1Administration of droperidol 30 minutes before surgery at a dose of 50 micrograms.kg-1
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone + ondansetron + Placebo | Active comparator | dexamethasone + ondansetron + Placebo Receives: Drug: Dexamethasone + ondansetron + Placebo |
| Dexamethasone + ondansetron + Droperidol | Experimental | dexamethasone + ondansetron + Droperidol Receives: Drug: Dexamethasone + ondansetron + Droperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative vomiting
Measured: 24 hours
Secondary outcomes (1)
Safety and Tolerability
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startDec 2010
- Primary completionJul 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative VomitingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Gilles ORLIAGUET, MD, PhD, Study chair, Necker Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01739985
- Sponsor's protocol ID
- P081228
- Other IDs
- 2009-017293-20, 2009
- Acronym
- VPOP2
- Status last verified
- Feb 2026
- First submitted
- 20 Jul 2012
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Gunter JB, McAuliffe JJ, Beckman EC, Wittkugel EP, Spaeth JP, Varughese AM. A factorial study of ondansetron, metoclopramide, and dexamethasone for emesis prophylaxis after adenotonsillectomy in children. Paediatr Anaesth. 2006 Nov;16(11):1153-65. doi: 10.1111/j.1460-9592.2006.01952.x.
PubMed 17040305Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51. doi: 10.1056/NEJMoa032196.
PubMed 15190136Bourdaud N, Francois C, Jacqmarcq O, Guye ML, Jean J, Studer C, Engrand-Donal C, Devys JM, Boutin F, Guyot E, Bouazza N, Treluyer JM, Orliaguet GA; VPOP2 group. Addition of droperidol to prophylactic ondansetron and dexamethasone in children at high risk for postoperative vomiting. A randomized, controlled, double-blind study. Br J Anaesth. 2017 Jun 1;118(6):918-923. doi: 10.1093/bja/aex099.
PubMed 28505233
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Vomiting in Children: Evaluation of the Addition of Droperidol to Conventional Bi-prophylaxis
- ClinicalTrials.gov ID
- NCT01739985
- Acronym / sponsor ID
- VPOP2 / P081228
- Conditions
- Postoperative Vomiting
- Keywords
- Postoperative, Vomiting, Children, Prophylaxis, Droperidol, Ondansetron, Dexamethasone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Dec 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 4 Dec 2012 (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.
The purpose of this study is to evaluate the benefit of addition of droperidol to prophylaxis with ondansetron and dexamethasone in children with high risk of postoperative vomiting (POV). In adults some authors showed that the effectiveness of prophylaxis is correlated to the number of molecules or specific procedures used.
Detailed description
The overall incidence of postoperative vomiting between 25 and 30% for the pediatric population, but it can reach a much higher incidence associated with certain types of surgery, about 80% in some studies like strabismus surgery for example. The identification of patients at high risk of POV is possible through the use of risk score. It is currently only one pediatric validated risk score, but the investigators conducted a multicenter study on this subject, whose results are being analyzed. This should allow us to identify children at high risk of POV. In this targeted population, the prophylaxis should allow a significant reduction in the incidence of POV. In children only one study tried to evaluate the association of ondansetron, dexamethasone and droperidol to prevent postoperative vomiting. However, different doses of the different molecules were combined, the extremely complicated design of this study and important methodological bias do not provide evidence about the superiority of the combination of three anti-emetics compared with two anti-emetics. Our present randomized, double-blind study is designed to compare the effectiveness of Droperidol in combination with a conventional bi-prophylaxis (dexamethasone/ondansetron) to the conventional bi-prophylaxis alone to decrease the occurrence of postoperative vomiting in children at high risk. The combination ondansetron and dexamethasone is frequently assessed as an association to prevent postoperative vomiting also in the adult population and in the pediatric population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone + ondansetron + Placebo | Active comparator | Drug: Dexamethasone + ondansetron + Placebodexamethasone + ondansetron + Placebo |
| Dexamethasone + ondansetron + Droperidol | Experimental | Drug: Dexamethasone + ondansetron + Droperidoldexamethasone + ondansetron + Droperidol |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children scheduled for surgery and with high risk of postoperative vomiting, i.e. with VPOP score up to 4
- Between 3 to 18 years
- Informed consent signed or the owner (s) of parental
- Children receiving a social security system
Key exclusion criteria (11 listed)
- Ambulatory surgery
- Preoperative corticosteroids
- Postoperative sedation
- Allergy known to droperidol, ondansetron or dexamethasone
- Known hypokaliemia
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 |
|---|---|---|
| Dexamethasone + ondansetron + PlaceboAdministration of ondansetron and dexamethasone immediately after induction of anesthesia. Ondansetron is administered at a dose of 100 micrograms.kg-1, dexamethasone at a dose of 125 microg x kg-1.Administration of the saline 30 minutes before the end of surgery | Drug | Dexamethasone + ondansetron + Placebo |
| Dexamethasone + ondansetron + DroperidolAdministration of ondansetron and dexamethasone immediately after induction of anesthesia. Ondansetron is administered at a dose of 100 micrograms.kg-1, dexamethasone at a dose of 125 microg x kg-1Administration of droperidol 30 minutes before surgery at a dose of 50 micrograms.kg-1 | Drug | Dexamethasone + ondansetron + Droperidol |
Primary outcome
Postoperative vomiting
Time frame: 24 hours
1 secondary outcome
Safety and Tolerability
Time frame: 24 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 13 Feb 2026.
- Background: PubMed 17040305Gunter JB, McAuliffe JJ, Beckman EC, Wittkugel EP, Spaeth JP, Varughese AM. A factorial study of ondansetron, metoclopramide, and dexamethasone for emesis prophylaxis after adenotonsillectomy in children. Paediatr Anaesth. 2006 Nov;16(11):1153-65. doi: 10.1111/j.1460-9592.2006.01952.x.
- Background: PubMed 15190136Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51. doi: 10.1056/NEJMoa032196.
- Results publication: PubMed 28505233Bourdaud N, Francois C, Jacqmarcq O, Guye ML, Jean J, Studer C, Engrand-Donal C, Devys JM, Boutin F, Guyot E, Bouazza N, Treluyer JM, Orliaguet GA; VPOP2 group. Addition of droperidol to prophylactic ondansetron and dexamethasone in children at high risk for postoperative vomiting. A randomized, controlled, double-blind study. Br J Anaesth. 2017 Jun 1;118(6):918-923. doi: 10.1093/bja/aex099.
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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.
Gilles ORLIAGUET, MD, PhD study chair
Necker Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone + ondansetron + Droperidol in people with Postoperative Vomiting, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 11 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 13 Feb 2026. 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 France. 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.
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?
Postoperative vomiting (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01739985, which also lists 3 linked publications.
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 13 Feb 2026; AzTrials last refreshed its copy on 2 Nov 2026.