Incidence of Post-operative Vomitings (POV) After Early Refeeding in Pediatric Day Case Surgery.
1 other identifier
interventional
808
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 25, 2013
CompletedFirst Posted
Study publicly available on registry
November 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedNovember 11, 2014
November 1, 2014
2 years
July 25, 2013
November 6, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Time between withdrawal of orotracheal tube and POV
The participant are followed for 3 days.
Study Arms (2)
Liberal group
EXPERIMENTALEarly refeeding
Control group
SHAM COMPARATORRefeeding in the day case ward (usual practice)
Interventions
Eligibility Criteria
You may qualify if:
- Patient of less than 4 years old
- A pediatric day case surgery scheduled
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Related Publications (1)
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.
PMID: 28203729DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2013
First Posted
November 11, 2014
Study Start
July 1, 2013
Primary Completion
July 1, 2015
Last Updated
November 11, 2014
Record last verified: 2014-11