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Completed

NCT Number: NCT00721682

Evaluation of Acute Pain in Maltreated Children

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.

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Key information

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

nantes University Hospital, Nantes, Pays de la Loire Region, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Evaluation of Acute Pain in Maltreated Children : a Prospective, Multicentric and Controlled Study

Acronym: ANTALPED

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jul 24, 2008
Registry last updated
Oct 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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