Pediatric Day Case Surgery Clinical Trial
| NCT number | NCT02288650 |
| Other study ID # | 5547 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | July 25, 2013 |
| Last updated | November 6, 2014 |
| Start date | July 2013 |
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)
| Status | Recruiting |
| Enrollment | 808 |
| Est. completion date | |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 3 Months to 4 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpitaux Universitaires de Strasbourg | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time between withdrawal of orotracheal tube and POV | The participant are followed for 3 days. | Yes |