Smartphone Evaluation of Postoperative Pain Profiles Following General Surgery in Children

NCT03675945 | Completed

• 1 other identifier: 18-HPNCL-05
• Study Type: observational
• Target: 1,576
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain Measurement

Outcome Measures

Primary Outcomes (2)

• Postoperative pain's evaluation by parents

  Measure of pain with scale Postoperative Pain Measure for Parents Short Form (PPMP-SF) using the mobile phone application. PPMP-SF scale has 10 items about child behavior. Each item score is 0 or is 1, score of 0 equals an absent sign, score of 1 equals a present sign. Total score is 10. Significant pain is greater than or equal to 6.

  from day 0 until day 10

• Postoperative pain's evaluation by patients

  Measure of pain with auto-evaluation Visual Analog Scale (VAS), using mobile phone application. VAS score goes from 0 to 10. Significant pain is greater than or equal to 3.

  from day 0 until day 10

Secondary Outcomes (3)

• Evaluation of Pre-operative anxiety of parents

  at the day before surgery

• Evaluation of Pre-operative anxiety of 7 years old and over patients

  at the day before surgery

• measure of postoperative adverse events

  from day 0 to day 10

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children operated in the different centers and leaving home will be included in the study

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Hôpitaaux Pédiatriques de Nice CHU-Lenval

Nice, France

Location

Related Publications (1)

• 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.

  PMID: 35239543 DERIVED

Study Officials

• Yannick Walrave, MD

  Fondation Lenval - Nice Children Hospital CHU-Lenval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 18, 2018
• Study Start: October 22, 2018
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: February 7, 2020

Record last verified: 2019-07

Locations

FR (1)