Evaluation of Acute Pain in Maltreated Children - Full Text View

Sponsored by:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00721682

Purpose

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.

Condition
Pain

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Evaluation of Acute Pain in Maltreated Children : a Prospective, Multicentric and Controlled Study

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of the quantitative scores of evaluation of the pain enters the two populations of children (maltreated and others) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Agreement between the evaluations of the pain made by the nursery nurses and those done by the doctors [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Study of the correlation enters the managed painful treatments and the recommendations of painful treatment for each pathology. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	96
Study Start Date:	November 2008
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Eligibility

Ages Eligible for Study:	up to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

maltreated children who consult in paediatric emergencies for recent fracture or burn

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721682

Contacts

Contact: Georges Picherot, MD	02 40 08 35 78 ext +33(0)	georges.picherot@chu-nantes.fr
Contact: Marie Hélène DROUINEAU, MD	02 40 08 36 10	mariehelene.drouineau@chu-nantes.fr

Locations

France
rennes university Hospital	Recruiting
rennes, France, 35203
Contact: Michel ROUSSEY, PhD michel.roussey@chu-rennes.fr
Angers university Hospital	Recruiting
Angers, France, 49933
Contact: Gérard CHAMPION, MD gechampion@chu-angers.fr
CHD les oudairies	Recruiting
La Roche sur Yon, France, 85000
Contact: Jean-Pierre BROSSIER, MD ean-pierre.brossier@chd-vendee.fr
CH CHOLET	Recruiting
CHOLET, France, 49325
Contact: Catherine RADET, MD catherine.radet@ch-cholet.fr
GHH	Recruiting
Le Havre, France, 76600
Contact: Pascal LE ROUX, MD pascal.le_roux@ch-havre.fr
CH Saint Nazaire	Recruiting
Saint Nazaire, France, 44600
Contact: Marc LE BIDEAU, MD m.lebideau@ch-saintnazaire.fr
France, Pays De La Loire
nantes University Hospital	Recruiting
Nantes, Pays De La Loire, France, 44093
Contact: Marie Hélène Drouineau, MD mariehelene.drouineau@chu-nantes.fr

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator:

Georges PICHEROT, MD

Nantes University Hospital

More Information

No publications provided

Responsible Party:	Nantes University Hospital ( General director )
Study ID Numbers:	BRD 08/6-K
Study First Received:	July 22, 2008
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00721682 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Nantes University Hospital:

Pediatry
Ill-treatment
Pain
maltreated children

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on September 09, 2009