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Outpatient Use of Analgesics in Children and Adolescents in France

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ClinicalTrials.gov Identifier: NCT03371043
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment
Outpatient Use of Analgesics in Children and Adolescents Other: users of analgesic medications

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

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Outpatient Use of Analgesics in Children and Adolescents in France
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2017

Group/Cohort Intervention/treatment
users of analgesic medications
Children and adolescents who are users of analgesic medications, 2012 to 2015
Other: users of analgesic medications
Children and adolescents who are users of analgesic medications, 2012 to 2015




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and adolesents who are users of analgesic medications, 2012 to 2015
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371043


Locations
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France
Hôpital Robert Debré, APHP
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Florentia Kaguelidou, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03371043    
Other Study ID Numbers: 15FKU-Analgesic
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Assistance Publique - Hôpitaux de Paris:
analgesics
opioids
outpatient drug use
pediatrics
Additional relevant MeSH terms:
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Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs