Clinical trial NCT00721682: Evaluation of Acute Pain in Maltreated Children
Official title: Evaluation of Acute Pain in Maltreated Children : a Prospective, Multicentric and Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Pediatry
Ill-treatment
Pain
maltreated children
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2008-07-24
Enrollment: 78
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: maltreated children who consult in paediatric emergencies for recent fracture or burn

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
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).
timeFrame: 3 years
Secondary outcomes:
measure: Comparison of the quantitative scores of evaluation of the pain enters the two populations of children (maltreated and others)
timeFrame: 3 years
measure: Agreement between the evaluations of the pain made by the nursery nurses and those done by the doctors
timeFrame: 3 years
measure: Study of the correlation enters the managed painful treatments and the recommendations of painful treatment for each pathology.
timeFrame: 3 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: nantes University Hospital
state: Pays de La Loire
city: Angers
country: France
facility: Angers university Hospital
city: Cholet
country: France
facility: Ch Cholet
city: La Roche sur Yon
country: France
facility: CHD les oudairies
city: Le Havre
country: France
facility: GHH
city: Rennes
country: France
facility: rennes university Hospital
city: Saint Nazaire
country: France
facility: CH Saint Nazaire
Study officials:
affiliation: Nantes University Hospital
name: Georges PICHEROT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.