Pain Measurement Clinical Trial
Official title:
Smartphone Evaluation of Postoperative Pain Profiles Following General Surgery in Children : a French Multi Center Randomized Trial (AlgoDARPEF)
Pain is common following surgery in children. Currently, no recent review of pain profiles at home has been performed on pediatric population in France following general surgery in children. The aim of this study is to evaluate the duration and severity of pain felt by children using a mobile phone application. All children operated in the different centers and leaving home will be included in the study. Children's pain scores will be measured using PPMP-SF scale (Postoperative Pain Measure for Parents Short Form). Data on prescribed and administered analgesia, nausea-vomiting, behavioral problems and parental satisfaction will be collected. The expected results are an inventory's objective observation of postoperative pain profiles at home following the different pediatric surgeries in France. The study will also highlight the different risk factors of postoperative pain (type of surgery, parental causes, reasons due to the child, medical causes).
Data from literature suggest that control of postoperative pain remains difficult and
insufficient despite interventions to improve the management of children's home-based
postoperative pain. In 2017, a recent Australian prospective audit confirms that pain is
still underestimated and under-treated by medical staff and home-based families. Currently,
no recent review of pain profiles at home has been performed on the pediatric population in
France following general surgery in children. The aim of this study is to evaluate the
duration and severity of pain felt by children using a mobile phone application.
The study is an epidemiological, observational, prospective and multicenter trial. All
children operated in the different centers and leaving home will be included in the study.
The peri-operative analgesic treatment will be left to the discretion of the various centers.
In addition to the surgical follow-up, post-operative follow-up at home will be carried out
using the smartphone application for all patients.
The use of the application will have been explained during the intervention's programming.
The application will be downloaded by the parents at home. Parents will be alerted by
notifications when they have tracking data to enter. The primary endpoint will be the
evaluation of postoperative pain thanks to PPMP-SF scale. Data on prescribed and administered
analgesia, nausea-vomiting, behavioral problems and parental satisfaction will be collected.
Statistical analysis will first include a descriptive study of the population. Qualitative
data will be expressed as means and standard deviations, and quantitative data as numbers and
percentages. Before carrying out each comparative analysis, the application's conditions of
the tests used will be verified. The different tests will be considered significant at the 5%
threshold unless otherwise specified.
The expected results are an inventory's objective observation of postoperative pain profiles
at home following the different pediatric surgeries in France. The study will also highlight
the different risk factors of postoperative pain (type of surgery, parental causes, reasons
due to the child, medical causes).
A recent study in Sweden in adult population has shown that systematic e-assessment can
improve patients' quality of recovery.
A mobile phone application on postoperative pain assessment in pediatric population would
improve the management of children's pain and therefore improve the quality of postoperative
recovery at home.
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