Evaluation of Acute Pain in Maltreated Children (ANTALPED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00721682
First received: July 22, 2008
Last updated: October 23, 2013
Last verified: October 2013
  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: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Acute Pain in Maltreated Children : a Prospective, Multicentric and Controlled Study

Resource links provided by NLM:


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 ]

Enrollment: 78
Study Start Date: November 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
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
GHH
Le Havre, France, 76600
rennes university Hospital
Rennes, France, 35203
CH Saint Nazaire
Saint Nazaire, France, 44600
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
ClinicalTrials.gov Identifier: NCT00721682     History of Changes
Other Study ID Numbers: BRD 08/6-K
Study First Received: July 22, 2008
Last Updated: October 23, 2013
Health Authority: France: Ministry of Health

Keywords provided by Nantes University Hospital:
Pediatry
Ill-treatment
Pain
maltreated children

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

ClinicalTrials.gov processed this record on September 18, 2014