Outpatient Use of Analgesics in Children and Adolescents in France

December 7, 2017 updated by: Assistance Publique - Hôpitaux de Paris
outpatient use of analgesics in children and adolescents in France from 2012 to 2015

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To describe the outpatient use of analgesics in children and adolescents in France from 2012 to 2015

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

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

Study Locations

  • France
      • Paris, France, 75019
        • Hôpital Robert Debré, APHP

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

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and adolesents who are users of analgesic medications, 2012 to 2015

Description

Inclusion Criteria:

  • all children and adolescents (0-17 years)
  • registered in the French Health Insurance Database from 2012-2015

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
users of analgesic medications
Children and adolescents who are users of analgesic medications, 2012 to 2015
Other: users of analgesic medications
Children and adolescents who are users of analgesic medications, 2012 to 2015

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic and anti-migraine drugs with a specific focus on opioids
Time Frame: 4 years
Quantification of the use of analgesics and changes over time
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Co-analgesic drugs (antidepressants and anticonvulsants) for pain management
Time Frame: 4 years

Use of co-analgesics. children and adolescents with epilepsy or a psychiatric disorder will be excluded from the main analysis in order to approximate as much as possible the use of these drugs for pain management Acute or chronic use Geographical distribution of prescribers For co-analgesics specifically: description of analgesic drugs used concomitantly.

Assessment of off-label use of analgesics by comparing descriptive usage data and regulatory marketing authorization conditions: for each analgesic; age of use and use of codeine in off-label indications will be assessed
4 years
Description of outpatient use of opioid analgesics over time in children with malignant disease
Time Frame: 4 years

Types of specific molecule and drug combinations: Assessment of these parameters will concern two distinct periods of time: ≤1 year after the diagnosis of cancer disease and >1 year after diagnosis. The diagnosis date will either the date of the first hospitalization for cancer or the date of full expenses coverage by the health insurance system for cancer disease, whichever comes first.

Profile of prescribers: hospital or private practice Profile of patients: age groups (0-23 months, 2-5 years, 6-11 years, 12-17 years) Acute or chronic use. Chronic use will be defined by at least 3 dispensations of the same analgesic drug (ATC code 5th level) in a period of 12 months.
4 years
Evaluation of the dispensing without medical prescription of analgesics in children and adolescents.
Time Frame: 4 years
Proportion of analgesics' dispensations without medical prescription presented by age and gender
4 years

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Florentia Kaguelidou, MD, PhD, Assistance Publique - Hôpitaux de Paris

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 (Actual)

September 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

December 7, 2017

First Posted (Actual)

December 13, 2017

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 7, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15FKU-Analgesic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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