Outpatient Use of Analgesics in Children and Adolescents in France

Study Overview
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Brief Summary
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outpatient use of analgesics in children and adolescents in France from 2012 to 2015

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

Official Title
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Outpatient Use of Analgesics in Children and Adolescents in France

Conditions
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Outpatient Use of Analgesics in Children and Adolescents

Intervention / Treatment
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* Other: users of analgesic medications


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all children and adolescents (0-17 years) registered in the French Health Insurance Database from 2012-2015

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| users of analgesic medications<br>Children and adolescents who are users of analgesic medications, 2012 to 2015 | Other: users of analgesic medications<br>* Children and adolescents who are users of analgesic medications, 2012 to 2015<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic and anti-migraine drugs with a specific focus on opioids | 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 | 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 | 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. | Proportion of analgesics' dispensations without medical prescription presented by age and gender | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesics, opioids, outpatient drug use, pediatrics