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OpenTrials
Completed

NCT Number: NCT03371043

Outpatient Use of Analgesics in Children and Adolescents in France

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

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Robert Debré, APHP

Paris, 75019, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

users of analgesic medications

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Dec 13, 2017
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.