Outpatient Use of Analgesics in Children and Adolescents in France
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75019
- Hôpital Robert Debré, APHP
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- all children and adolescents (0-17 years)
- registered in the French Health Insurance Database from 2012-2015
Study Plan
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
|
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
Investigators
- Principal Investigator: Florentia Kaguelidou, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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