PainANTALPEDNCT00721682
Evaluation of Acute Pain in Maltreated Children
An observational study of Pain, run by Nantes University Hospital at 7 sites in France.
Trial summary
The hypothesis of this study is nonrecognition by the medical team of pain in maltreated children. These children would have a particular painful behaviour, "quiet". The management of their pain would be then unsuited, which could explain their complex relation with the pain in the adulthood. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Pain
- How many people
- 78 participants
- Where
- 7 sitesFrance
- Study dates
- Nov 2008to Apr 2013
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Study population: maltreated children who consult in paediatric emergencies for recent fracture or burn
Who may be able to join
- Age between 0 and 6 years
- Consultation in the emergency cares for traumatism with type of fracture and/or burn
- Time of the traumatism lower than 24 hours
- Information of the two parents or the parental authority and collection of the non-opposition.
Who cannot join
- Old superior at 6 years
- Any type of traumatism other than a fracture and/or a burn
- Traumatism without possible dating or with a time of consultation higher than 24 hours
- Opposition of the parents formulated after their information by the medical team
- Child who can not have an evaluation of the pain with the chosen scales
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Angers university Hospital
Angers, 49933
Ch Cholet
Cholet, 49325
CHD les oudairies
La Roche-sur-Yon, 85000
GHH
Le Havre, 76600
nantes University Hospital
Nantes, Pays de la Loire Region, 44093
rennes university Hospital
Rennes, 35203
CH Saint Nazaire
Saint-Nazaire, 44600
About this study
Official title: Evaluation of Acute Pain in Maltreated Children : a Prospective, Multicentric and Controlled Study
The hypothesis of this study is nonrecognition by the medical team of pain in maltreated children. These children would have a particular painful behaviour, "quiet". The management of their pain would be then unsuited, which could explain their complex relation with the pain in the adulthood. A pilot study realized in the CHU of Nantes on 11 files of maltreated children showed that they had very low scores of evaluation of the pain, in spite of severe traumatisms. There is, at the moment, no data in the literature on the acute pain of the maltreated children.
- Conditions
- Pain
- Keywords
- Pediatry, Ill-treatment, Pain, maltreated children
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | The CASE group will be composed of children for whom the medical team will have chosen to carry out a sign of alert of ill-treatment during his hospitalization and with no plausible cause of traumatism | |
| control | The Control group will be composed of children, consulting with the emergency care for traumatism, not having a sign of alarm and having a plausible cause of traumatism. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The principal judgement criterion is the proportion of children without recognized pain, measured with the rating scales validated in paediatrics, in T0, in the two populations of children (maltreated and others).
Measured: 3 years
Secondary outcomes (3)
Comparison of the quantitative scores of evaluation of the pain enters the two populations of children (maltreated and others)
Measured: 3 years
Agreement between the evaluations of the pain made by the nursery nurses and those done by the doctors
Measured: 3 years
Study of the correlation enters the managed painful treatments and the recommendations of painful treatment for each pathology.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georges PICHEROT, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721682
- Sponsor's protocol ID
- BRD 08/6-K
- Acronym
- ANTALPED
- Status last verified
- Oct 2013
- First submitted
- 22 Jul 2008
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Drouineau MH, Guenego E, Sebille-Rivain V, Vrignaud B, Balencon M, Blanchais T, Levieux K, Vabres N, Picherot G, Guen CG. Do abused young children feel less pain? Child Abuse Negl. 2017 Mar;65:248-254. doi: 10.1016/j.chiabu.2017.02.002. Epub 2017 Feb 11.
PubMed 28196343
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Acute Pain in Maltreated Children : a Prospective, Multicentric and Controlled Study
- ClinicalTrials.gov ID
- NCT00721682
- Acronym / sponsor ID
- ANTALPED / BRD 08/6-K
- Conditions
- Pain
- Keywords
- Pediatry, Ill-treatment, Pain, maltreated children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Jul 2008 (estimated)
- 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.
The hypothesis of this study is nonrecognition by the medical team of pain in maltreated children. These children would have a particular painful behaviour, "quiet". The management of their pain would be then unsuited, which could explain their complex relation with the pain in the adulthood. A pilot study realized in the CHU of Nantes on 11 files of maltreated children showed that they had very low scores of evaluation of the pain, in spite of severe traumatisms. There is, at the moment, no data in the literature on the acute pain of the maltreated children.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –The CASE group will be composed of children for whom the medical team will have chosen to carry out a sign of alert of ill-treatment during his hospitalization and with no plausible cause of traumatism |
| control | – | –The Control group will be composed of children, consulting with the emergency care for traumatism, not having a sign of alarm and having a plausible cause of traumatism. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- maltreated children who consult in paediatric emergencies for recent fracture or burn
Key inclusion criteria (4 listed)
- Age between 0 and 6 years
- Consultation in the emergency cares for traumatism with type of fracture and/or burn
- Time of the traumatism lower than 24 hours
- Information of the two parents or the parental authority and collection of the non-opposition.
Key exclusion criteria (5 listed)
- Old superior at 6 years
- Any type of traumatism other than a fracture and/or a burn
- Traumatism without possible dating or with a time of consultation higher than 24 hours
- Opposition of the parents formulated after their information by the medical team
- Child who can not have an evaluation of the pain with the chosen scales
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The principal judgement criterion is the proportion of children without recognized pain, measured with the rating scales validated in paediatrics, in T0, in the two populations of children (maltreated and others).
Time frame: 3 years
3 secondary outcomes
Comparison of the quantitative scores of evaluation of the pain enters the two populations of children (maltreated and others)
Time frame: 3 years
Agreement between the evaluations of the pain made by the nursery nurses and those done by the doctors
Time frame: 3 years
Study of the correlation enters the managed painful treatments and the recommendations of painful treatment for each pathology.
Time frame: 3 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 24 Oct 2013.
- Derived from this study: PubMed 28196343Drouineau MH, Guenego E, Sebille-Rivain V, Vrignaud B, Balencon M, Blanchais T, Levieux K, Vabres N, Picherot G, Guen CG. Do abused young children feel less pain? Child Abuse Negl. 2017 Mar;65:248-254. doi: 10.1016/j.chiabu.2017.02.002. Epub 2017 Feb 11.
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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.
Georges PICHEROT, MD principal investigator
Nantes University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Nantes University Hospital at 7 sites 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 4 inclusion and 5 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 24 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The principal judgement criterion is the proportion of children without recognized pain, measured with the rating scales validated in paediatrics, in T0, in the two populations of children (maltreated and others). (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00721682, which also lists 1 linked publication.
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 24 Oct 2013.