Outpatient Use of Analgesics in Children and AdolescentsNCT03371043
Outpatient Use of Analgesics in Children and Adolescents in France
An observational study of Outpatient Use of Analgesics in Children and Adolescents, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
outpatient use of analgesics in children and adolescents in France from 2012 to 2015 Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Outpatient Use of Analgesics in Children and Adolescents
- What is being tested?
- users of analgesic medications
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and adolesents who are users of analgesic medications, 2012 to 2015
Who may be able to join
- all children and adolescents (0-17 years)
- registered in the French Health Insurance Database from 2012-2015
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
outpatient use of analgesics in children and adolescents in France from 2012 to 2015
Read the detailed description
To describe the outpatient use of analgesics in children and adolescents in France from 2012 to 2015
- Being tested
- users of analgesic medications
- Keywords
- analgesics, opioids, outpatient drug use, pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
users of analgesic medicationsOther
Children and adolescents who are users of analgesic medications, 2012 to 2015
| Study group | Role | What they receive |
|---|---|---|
| users of analgesic medications | Children and adolescents who are users of analgesic medications, 2012 to 2015 Receives: Other: users of analgesic medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic and anti-migraine drugs with a specific focus on opioids
Quantification of the use of analgesics and changes over time
Measured: 4 years
Secondary outcomes (3)
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
Measured: 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.
Measured: 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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study startSep 2015
- Primary completionSep 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outpatient Use of Analgesics in Children and AdolescentsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florentia Kaguelidou, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371043
- Sponsor's protocol ID
- 15FKU-Analgesic
- Status last verified
- Nov 2017
- First submitted
- 7 Sep 2016
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Use of Analgesics in Children and Adolescents in France
- ClinicalTrials.gov ID
- NCT03371043
- Acronym / sponsor ID
- 15FKU-Analgesic
- Keywords
- analgesics, opioids, outpatient drug use, pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
outpatient use of analgesics in children and adolescents in France from 2012 to 2015
Detailed description
To describe the outpatient use of analgesics in children and adolescents in France from 2012 to 2015
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| users of analgesic medications | – | Other: users of analgesic medicationsChildren and adolescents who are users of analgesic medications, 2012 to 2015 |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolesents who are users of analgesic medications, 2012 to 2015
Key inclusion criteria (2 listed)
- all children and adolescents (0-17 years)
- registered in the French Health Insurance Database from 2012-2015
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| users of analgesic medicationsChildren and adolescents who are users of analgesic medications, 2012 to 2015 | Other | users of analgesic medications |
Primary outcome
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
3 secondary outcomes
Co-analgesic drugs (antidepressants and anticonvulsants) for pain management
Time frame: 4 years
Description of outpatient use of opioid analgesics over time in children with malignant disease
Time frame: 4 years
Evaluation of the dispensing without medical prescription of analgesics in children and adolescents.
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florentia Kaguelidou, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Outpatient Use of Analgesics in Children and Adolescents, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic and anti-migraine drugs with a specific focus on opioids (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.