Evaluation of Acute Pain in Maltreated Children (ANTALPED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00721682
Recruitment Status : Completed
First Posted : July 24, 2008
Last Update Posted : October 24, 2013
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease

Study Type : Observational
Actual Enrollment : 78 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Acute Pain in Maltreated Children : a Prospective, Multicentric and Controlled Study
Study Start Date : November 2008
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

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
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Comparison of the quantitative scores of evaluation of the pain enters the two populations of children (maltreated and others) [ Time Frame: 3 years ]
  2. Agreement between the evaluations of the pain made by the nursery nurses and those done by the doctors [ Time Frame: 3 years ]
  3. Study of the correlation enters the managed painful treatments and the recommendations of painful treatment for each pathology. [ Time Frame: 3 years ]

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
maltreated children who consult in paediatric emergencies for recent fracture or burn

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

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 identifier (NCT number): NCT00721682

nantes University Hospital
Nantes, Pays de La Loire, France, 44093
Angers university Hospital
Angers, France, 49933
Ch Cholet
Cholet, France, 49325
CHD les oudairies
La Roche sur Yon, France, 85000
Le Havre, France, 76600
rennes university Hospital
Rennes, France, 35203
CH Saint Nazaire
Saint Nazaire, France, 44600
Sponsors and Collaborators
Nantes University Hospital
Principal Investigator: Georges PICHEROT, MD Nantes University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nantes University Hospital Identifier: NCT00721682     History of Changes
Other Study ID Numbers: BRD 08/6-K
First Posted: July 24, 2008    Key Record Dates
Last Update Posted: October 24, 2013
Last Verified: October 2013

Keywords provided by Nantes University Hospital:
maltreated children

Additional relevant MeSH terms:
Acute Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms