Outpatient Use of Analgesics in Children and Adolescents Clinical Trial
Official title:
Outpatient Use of Analgesics in Children and Adolescents in France
| Verified date | November 2017 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
outpatient use of analgesics in children and adolescents in France from 2012 to 2015
| Status | Completed |
| Enrollment | 1 |
| Est. completion date | September 2017 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 17 Years |
| Eligibility |
Inclusion Criteria: - all children and adolescents (0-17 years) - registered in the French Health Insurance Database from 2012-2015 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Robert Debré, APHP | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Analgesic and anti-migraine drugs with a specific focus on opioids | Quantification of the use of analgesics and changes over time | 4 years | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |