NCT00721682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

October 24, 2013

Status Verified

October 1, 2013

Enrollment Period

4.4 years

First QC Date

July 22, 2008

Last Update Submit

October 23, 2013

Conditions

Pain

Keywords

PediatryIll-treatmentPainmaltreated children

Outcome Measures

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).

    3 years

Secondary Outcomes (3)

  • Comparison of the quantitative scores of evaluation of the pain enters the two populations of children (maltreated and others)

    3 years

  • Agreement between the evaluations of the pain made by the nursery nurses and those done by the doctors

    3 years

  • Study of the correlation enters the managed painful treatments and the recommendations of painful treatment for each pathology.

    3 years

Study Arms (2)

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 Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

nantes University Hospital

Nantes, Pays de la Loire Region, 44093, France

Location

Angers university Hospital

Angers, 49933, France

Location

Ch Cholet

Cholet, 49325, France

Location

CHD les oudairies

La Roche-sur-Yon, 85000, France

Location

GHH

Le Havre, 76600, France

Location

rennes university Hospital

Rennes, 35203, France

Location

CH Saint Nazaire

Saint-Nazaire, 44600, France

Location

Related Publications (1)

  • 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.

    PMID: 28196343DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Georges PICHEROT, MD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2008

First Posted

July 24, 2008

Study Start

November 1, 2008

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

October 24, 2013

Record last verified: 2013-10

Locations

FR(7)