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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02015858
Other study ID # 2013/22
Secondary ID 2013-A00612-43
Status Completed
Phase N/A
First received December 10, 2013
Last updated October 28, 2016
Start date June 2013
Est. completion date May 2014

Study information

Verified date October 2016
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational

Clinical Trial Summary

Pain evaluation remains a clinical problem. Pain Monitor allows pain evaluation using the measurement of skin conductance.

Withdrawal of chest tube can be painful and the purpose of the study was to compare auto-evaluation of pain (visual analogic scale) and the index measured by the Pain Monitor.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- patients undergoing removal of a chest tube after lung surgery,

- patients able to indicate the pain score.

Exclusion Criteria:

- pregnancy, lactation ,

- insulin-dependent diabetes with dysautonomia,

- central or peripheral neurological disease, agitation,

- inability to understand the protocol,

- inability to use the Pain Monitor: skin abnormalities at the site of measurement, pacemaker or implantable defibrillator, condition affecting the sympathetic nervous system, tremor of the extremities,

- contra-indication to oral morphine ,

- respiratory failure, severe hepatic insufficiency, intracranial hypertension, epilepsy associations

- recent administration of neostigmine or of atropine.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Chest drain withdrawal

Device:
Pain Monitor


Locations

Country Name City State
France Hopital Foch Suresnes

Sponsors (1)

Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain monitor evaluation of pain Comparison between Pain monitor index and auto-evaluation of pain (numerical scale from 0 -no pain- to 10 - maximal pain) 1 hour No
Secondary Pain intensity Evolution of Pain monitor index and of auto-evaluation of pain (numerical scale from 0 -no pain- to 10 - maximal pain) during the chest tube withdrawal 1 hour Yes
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