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Outpatient Use of Analgesics in Children and Adolescents in France

Outpatient Use of Analgesics in Children and Adolescents in France

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03371043
Enrollment
1
Registered
2017-12-13
Start date
2015-09-30
Completion date
2017-09-30
Last updated
2017-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Outpatient Use of Analgesics in Children and Adolescents

Keywords

analgesics, opioids, outpatient drug use, pediatrics

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

Interventions

OTHERusers of analgesic medications

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Analgesic and anti-migraine drugs with a specific focus on opioids4 yearsQuantification of the use of analgesics and changes over time

Secondary

MeasureTime frameDescription
Co-analgesic drugs (antidepressants and anticonvulsants) for pain management4 yearsUse 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 disease4 yearsTypes 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 yearsProportion of analgesics' dispensations without medical prescription presented by age and gender

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026