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

U

University Hospital, Strasbourg, France

Status

Unknown

Conditions

Pediatric Day Case Surgery
Post-operative Vomiting Incidence

Treatments

Other: early refeeding
Other: refeeding only in the recovery room (usual practice).

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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)

Enrollment

808 estimated patients

Sex

All

Ages

3 months to 4 years old

Volunteers

No Healthy Volunteers

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

Trial design

808 participants in 2 patient groups

Liberal group
Experimental group
Description:
Early refeeding
Treatment:
Other: early refeeding
Control group
Sham Comparator group
Description:
Refeeding in the day case ward (usual practice)
Treatment:
Other: refeeding only in the recovery room (usual practice).

Trial contacts and locations

1

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Central trial contact

Chloé CHAUVIN, Doctor

Data sourced from clinicaltrials.gov

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