Post-operative Vomiting IncidenceNCT02288650
Incidence of Post-operative Vomitings (POV) After Early Refeeding in Pediatric Day Case Surgery.
A study testing early refeeding and refeeding only in the recovery room (usual practice). in people with Post-operative Vomiting Incidence and Pediatric Day Case Surgery, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
At the child, the post-operative vomitings (POV) remain the main post-operative complication in term of frequency. They also represent the first cause of unforeseen hospitalization in day case surgery. The causes of POV are multiple, including in particular the post-operative prescription of opioids. Read more about this study
- Who is it for?
- Ages 3 months to 4 years
- Conditions the study is for
- Post-operative Vomiting Incidence, Pediatric Day Case Surgery
- What is being tested?
- early refeeding and refeeding only in the recovery room (usual practice).
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 808 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Jul 2015
- 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 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient of less than 4 years old
- A pediatric day case surgery scheduled
Who cannot join
- Child lower age or 3 month old equal
- Premature child of conceptional age lower than 60 weeks
- Anesthetic or surgical constraint dissuading day case surgery or early refeeding
- Digestive pathology predisposing to the VPO (Hernia hiatal, gastro-oesophageal reflux)
- treatment interfering with emesis (imidazoles, neuroleptic)
- Period of exclusion defined by another study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg
Chloé Chauvin, 3 88 12 70 89 ext. +33, Chloe.CHAUVIN@chru-strasbourg.fr
About this study
At the child, the post-operative vomitings (POV) remain the main post-operative complication in term of frequency. They also represent the first cause of unforeseen hospitalization in day case surgery. The causes of POV are multiple, including in particular the post-operative prescription of opioids. The role of the premature refeeding remains discussed.
Up to the age of 4 years, acute pain is difficult to distinguish from other causes of distress (anxiety, anger but also hunger) being able to make prescribe wrongly opioids in post-operative.
Read more
The main objective of this study is to estimate the POV in pediatric day case surgery after early refeeding with clear liquids in the recovery room or only in the day case wards (usual practice).
The secondary objectives are to estimate the time on returning to the day case ward, at home, the post-operative opioid consumption, early refeeding adverse effects (desaturation, swallowing trouble)
- Being tested
- early refeeding, refeeding only in the recovery room (usual practice).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early refeedingOther
refeeding only in the recovery room (usual practice).Other
| Study group | Role | What they receive |
|---|---|---|
| Liberal group | Experimental | Early refeeding Receives: Other: early refeeding |
| Control group | Sham comparator | Refeeding in the day case ward (usual practice) Receives: Other: refeeding only in the recovery room (usual practice). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time between withdrawal of orotracheal tube and POV
Measured: The participant are followed for 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startJul 2013
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative Vomiting IncidenceStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 808 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288650
- Sponsor's protocol ID
- 5547
- Status last verified
- Nov 2014
- First submitted
- 25 Jul 2013
- Last updated
- 11 Nov 2014
- Results posted
- No
Publications
Chauvin C, Schalber-Geyer AS, Lefebvre F, Bopp C, Carrenard G, Marcoux L, Mayer JF, Schwaab C, Joshi GP, Diemunsch P. Early postoperative oral fluid intake in paediatric day case surgery influences the need for opioids and postoperative vomiting: a controlled randomized trialdagger. Br J Anaesth. 2017 Mar 1;118(3):407-414. doi: 10.1093/bja/aew463.
PubMed 28203729
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Post-operative Vomitings (POV) After Early Refeeding in Pediatric Day Case Surgery.
- ClinicalTrials.gov ID
- NCT02288650
- Acronym / sponsor ID
- 5547
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 808 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (estimated)
- First posted
- 11 Nov 2014 (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.
At the child, the post-operative vomitings (POV) remain the main post-operative complication in term of frequency. They also represent the first cause of unforeseen hospitalization in day case surgery. The causes of POV are multiple, including in particular the post-operative prescription of opioids. The role of the premature refeeding remains discussed.
Up to the age of 4 years, acute pain is difficult to distinguish from other causes of distress (anxiety, anger but also hunger) being able to make prescribe wrongly opioids in post-operative.
The main objective of this study is to estimate the POV in pediatric day case surgery after early refeeding with clear liquids in the recovery room or only in the day case wards (usual practice).
The secondary objectives are to estimate the time on returning to the day case ward, at home, the post-operative opioid consumption, early refeeding adverse effects (desaturation, swallowing trouble)
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal group | Experimental | Other: early refeedingEarly refeeding |
| Control group | Sham comparator | Other: refeeding only in the recovery room (usual practice).Refeeding in the day case ward (usual practice) |
Who may qualify
- Ages
- 3 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patient of less than 4 years old
- A pediatric day case surgery scheduled
Key exclusion criteria (6 listed)
- Child lower age or 3 month old equal
- Premature child of conceptional age lower than 60 weeks
- Anesthetic or surgical constraint dissuading day case surgery or early refeeding
- Digestive pathology predisposing to the VPO (Hernia hiatal, gastro-oesophageal reflux)
- treatment interfering with emesis (imidazoles, neuroleptic)
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 |
|---|---|---|
| early refeeding | Other | Liberal group |
| refeeding only in the recovery room (usual practice). | Other | Control group |
Primary outcome
Time between withdrawal of orotracheal tube and POV
Time frame: The participant are followed for 3 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
- Derived from this study: PubMed 28203729Chauvin C, Schalber-Geyer AS, Lefebvre F, Bopp C, Carrenard G, Marcoux L, Mayer JF, Schwaab C, Joshi GP, Diemunsch P. Early postoperative oral fluid intake in paediatric day case surgery influences the need for opioids and postoperative vomiting: a controlled randomized trialdagger. Br J Anaesth. 2017 Mar 1;118(3):407-414. doi: 10.1093/bja/aew463.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early refeeding and refeeding only in the recovery room (usual practice). in people with Post-operative Vomiting Incidence and Pediatric Day Case Surgery, run by University Hospital, Strasbourg, France 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Nov 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 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. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chloé CHAUVIN, Doctor (3 12 70 89 ext. +33, Chloe.CHAUVIN@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time between withdrawal of orotracheal tube and POV (time frame: The participant are followed for 3 days.). 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 NCT02288650, which also lists 1 linked publication.
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 11 Nov 2014.