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Clinical Trials/NCT02288650
NCT02288650
Unknown
Not Applicable

Incidence of Post-operative Vomitings (POV) After Early Refeeding in Pediatric Day Case Surgery.

University Hospital, Strasbourg, France1 site in 1 country808 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-operative Vomiting Incidence
Sponsor
University Hospital, Strasbourg, France
Enrollment
808
Locations
1
Primary Endpoint
Time between withdrawal of orotracheal tube and POV
Last Updated
11 years ago

Overview

Brief 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. 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)

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
July 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Time between withdrawal of orotracheal tube and POV

Time Frame: The participant are followed for 3 days.

Study Sites (1)

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