Evaluation of Acute Pain in Maltreated Children

Pain Clinical Trial

— ANTALPED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721682
• Other study ID #: BRD 08/6-K
• Status: Completed
• Phase: N/A
• First received: July 22, 2008
• Last updated: October 23, 2013
• Start date: November 2008
• Est. completion date: April 2013

Study information

• Verified date: October 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Pain
• Pain

Locations

Country	Name	City	State
France	Angers university Hospital	Angers
France	Ch Cholet	Cholet
France	CHD les oudairies	La Roche sur Yon
France	GHH	Le Havre
France	nantes University Hospital	Nantes	Pays de La Loire
France	rennes university Hospital	Rennes
France	CH Saint Nazaire	Saint Nazaire

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Comparison of the quantitative scores of evaluation of the pain enters the two populations of children (maltreated and others)		3 years	No
Secondary	Agreement between the evaluations of the pain made by the nursery nurses and those done by the doctors		3 years	No
Secondary	Study of the correlation enters the managed painful treatments and the recommendations of painful treatment for each pathology.		3 years	No