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

Sponsor
University Hospital, Rouen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04564248
Collaborator
(none)
340
Enrollment
1
Location
2
Arms
19
Anticipated Duration (Months)
17.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Website access
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
340 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Setting up a Website in Paediatric Surgery at the Rouen University Hospital for Parents and Children to Better Understand the Postoperative Prescription of Painkillers.
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: website access for families

Other: Website access
website access will be provide to families
No Intervention: standard care

Outcome Measures

Primary Outcome Measures

  1. Number of analgesic treatment taken [day 1 after surgery]

Secondary Outcome Measures

  1. Number of analgesic treatment taken [day 2 after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rouen University Hospital Rouen France

Sponsors and Collaborators

  • University Hospital, Rouen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT04564248
Other Study ID Numbers:
  • 2020/0045/HP
First Posted:
Sep 25, 2020
Last Update Posted:
May 7, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 7, 2021