Setting up a Website in Paediatric Surgery at the Rouen University Hospital for Parents and Children to Better Understand the Postoperative Prescription of Painkillers. (DOLIPAR)

May 6, 2021 updated by: University Hospital, Rouen
Although outpatient surgery is increasing in France, particularly in paediatrics, compliance with analgesics prescriptions and pain management on return home remain poorly controlled parameters, although they are essential for optimal care. This is due, among other things, to parents' lack of knowledge and fears about the medicines prescribed to them. The paediatric anaesthesia unit of the Rouen University Hospital has set up a website for families to improve understanding of and compliance with the prescription of painkillers and thus improve the management of postoperative pain.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Rouen, France
        • Rouen University Hospital
        • Contact:
          • Pascal DELMON, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with a Physical status score equal or II
  • Ages 2-12
  • Receiving outpatient surgery according to the eligibility criteria established in the latest expert recommendations in 2009 and in accordance with the service's practices

Exclusion Criteria:

  • Lack of access to internet
  • Cognitive dysfunction in children that interfere with understanding instructions
  • Patient already receiving a analgesic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: standard care
EXPERIMENTAL: website access for families
Other: Website access
website access will be provide to families

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of analgesic treatment taken
Time Frame: day 1 after surgery
day 1 after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of analgesic treatment taken
Time Frame: day 2 after surgery
day 2 after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Pascal DELMON, MD, Rouen University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

September 21, 2020

First Submitted That Met QC Criteria

September 21, 2020

First Posted (ACTUAL)

September 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2020/0045/HP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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