NCT04564248

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

May 17, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2023

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

September 21, 2020

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of analgesic treatment taken

    day 1 after surgery

Secondary Outcomes (1)

  • Number of analgesic treatment taken

    day 2 after surgery

Study Arms (2)

website access for families

EXPERIMENTAL
Other: Website access

standard care

NO INTERVENTION

Interventions

website access will be provide to families

website access for families

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

Study Officials

  • Pascal DELMON, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 25, 2020

Study Start

May 17, 2021

Primary Completion

April 23, 2023

Study Completion

April 23, 2023

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations