Outpatient Use of Analgesics in Children and Adolescents in France

Completed

• Conditions: Outpatient Use of Analgesics in Children and Adolescents
• Interventions: Other: users of analgesic medications

• Registration Number: NCT03371043
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2016-09
• Study First Submitted: 2016-09-07
• Study Completion: 2017-09
• Status Verified: 2017-11
• Study First Submitted QC: 2017-12-07
• Last Update Submitted: 2017-12-07
• Study First Posted: 2017-12-13
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
users of analgesic medications	users of analgesic medications	Children and adolescents who are users of analgesic medications, 2012 to 2015

Primary Outcome Measures

Name	Time	Method
Analgesic and anti-migraine drugs with a specific focus on opioids	4 years	Quantification of the use of analgesics and changes over time

Secondary Outcome Measures

Name	Time	Method
Co-analgesic drugs (antidepressants and anticonvulsants) for pain management	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
Description of outpatient use of opioid analgesics over time in children with malignant disease	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.
Evaluation of the dispensing without medical prescription of analgesics in children and adolescents.	4 years	Proportion of analgesics' dispensations without medical prescription presented by age and gender

Trial Locations

Locations (1)

Hôpital Robert Debré, APHP; 🇫🇷 Paris, France