- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02288650
Incidence of Post-operative Vomitings (POV) After Early Refeeding in Pediatric Day Case Surgery.
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chloé CHAUVIN, Doctor
- Phone Number: +33 3 12 70 89
- Email: Chloe.CHAUVIN@chru-strasbourg.fr
Study Locations
-
-
-
Strasbourg, France
- Recruiting
- Hopitaux Universitaires De Strasbourg
-
Contact:
- Chloé Chauvin
- Phone Number: +33 3 88 12 70 89
- Email: Chloe.CHAUVIN@chru-strasbourg.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient of less than 4 years old
- A pediatric day case surgery scheduled
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liberal group
Early refeeding
|
|
Sham Comparator: Control group
Refeeding in the day case ward (usual practice)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time between withdrawal of orotracheal tube and POV
Time Frame: The participant are followed for 3 days.
|
The participant are followed for 3 days.
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5547
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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