Clinical trial NCT03675945: Smartphone Evaluation of Postoperative Pain Profiles Following General Surgery in Children
Official title: Smartphone Evaluation of Postoperative Pain Profiles Following General Surgery in Children : a French Multi Center Randomized Trial (AlgoDARPEF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain Measurement
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 1576
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children operated in the different centers and leaving home will be included in the study

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All children operated in the centers participating in the study, regardless of age.
* Possession of a smartphone by one of the two parents.
* Affiliated parent or beneficiary of a Social Security scheme.
* Collection of the non-opposition of one of the parents or the representative of the parental authority

Exclusion Criteria:

* Parents who refused or do not understand the protocol
* Parents who don't have the necessary hardware to download the application for mobile phone
* Non-French parents
* Vulnerable people according to article L1121-6 of the public health code

Primary outcomes:
measure: Postoperative pain's evaluation by parents
timeFrame: from day 0 until day 10
measure: Postoperative pain's evaluation by patients
timeFrame: from day 0 until day 10
Secondary outcomes:
measure: Evaluation of Pre-operative anxiety of parents
timeFrame: at the day before surgery
measure: Evaluation of Pre-operative anxiety of 7 years old and over patients
timeFrame: at the day before surgery
measure: measure of postoperative adverse events
timeFrame: from day 0 to day 10
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpitaaux Pédiatriques de Nice CHU-Lenval
Study officials:
affiliation: Fondation Lenval - Nice Children Hospital CHU-Lenval
name: Yannick Walrave, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walrave Y, Carles M, Evain JN, Ikonomoff T, Marie A, Ludot H, Bourdaud N, Kern D, Lejus-Bourdeau C, Orliaguet G, Rosello O, Ecoffey C, Savoldelli C, Perissier C, Delacquis M, Vare B, Donzeau D, Cousin C, Langlais E, Breaud J, Jonckheer K, Dadure C, De la Briere F; Association of French Pediatric Anaesthesia and Intensive Care Medicine (ADARPEF). A follow-up of pain reported by children undergoing outpatient surgery using a smartphone application: AlgoDARPEF multicenter descriptive prospective study. Pain. 2022 Nov 1;163(11):2224-2231. doi: 10.1097/j.pain.0000000000002620. Epub 2022 Mar 1.