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

Not Applicable

• Conditions: Post-operative Vomiting Incidence; Pediatric Day Case Surgery
• Interventions: Other: early refeeding; Other: refeeding only in the recovery room (usual practice).

• Registration Number: NCT02288650
• Lead Sponsor: University Hospital, Strasbourg, France

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-25
• Status Verified: 2014-11
• Study First Submitted QC: 2014-11-06
• Last Update Submitted: 2014-11-06
• Study First Posted: 2014-11-11
• Last Update Posted: 2014-11-11
• Primary Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 808

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal group	early refeeding	Early refeeding
Control group	refeeding only in the recovery room (usual practice).	Refeeding in the day case ward (usual practice)

Primary Outcome Measures

Name	Time	Method
Time between withdrawal of orotracheal tube and POV	The participant are followed for 3 days.

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France