PERFECTA - Intravenous analgesics for post-operative pain: patterns of use in high-risk populations ARCHIVE

Head :
Boccard Éric, Bristol-Myers Squibb
Schmidely Nathalie, Bristol-Myers Squibb

Last update : 01/01/2018 | Version : 1 | ID : 126

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Intravenous analgesics for post-operative pain: patterns of use in high-risk populations
Sign or acronym PERFECTA
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation --
General Aspects
Health determinants Iatrogenic
Others (details) Pain
Keywords Post-chirurgical, treatment for pain, IV pain killers
Scientific investigator(s) (Contact)
Name of the director Boccard
Surname Éric
Address 3, rue J. Monier - 92500 Rueil Malmaison
Phone +33 (0)1 58 83 60 00
Email eric.boccard@bms.com
Unit Bristol-Myers Squibb
Name of the director Schmidely
Surname Nathalie
Address 3, rue J. Monier - 92500 Rueil Malmaison
Phone +33 (0)1 58 83 60 00
Email nathalie.schmidely@bms.com
Unit Bristol-Myers Squibb
Collaborations
Funding
Funding status Private
Details Bristol-Myers Squibb
Governance of the database
Sponsor(s) or organisation(s) responsible Bristol-Myers Squibb France (BMS)
Organisation status Private
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Not-repeated cross-sectional studies (except case control studies)
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. random sampling in clusters
Database objective
Main objective Describe the post-chirurgical drug treatment for pain after a surgical intervention, in target groups of patients having specific risks of developing complications during the use of certain classes of analgesics
Inclusion criteria M/F patients, >=18 years, have an ASA score of level 3 or 4 and having undergone a surgical intervention, including coeloscopy, excluding cardiac surgery and neurosurgery, requiring antalgic treatment through IV in order to relieve postoperative pain.
Patients having at least one of the following risk factors: aged ≥ 65 years, OCPD including sleep apnea, high blood pressure, kidney, heart or liver failure.
Population type
Age Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Great age (80 years and more)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area Metropolitan France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2007
Date of last collection (YYYY or MM/YYYY) 2008
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals 1829
Data
Database activity Data collection completed
Type of data collected Clinical data
Clinical data (detail) Direct physical measures
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Procedures
Data collection method paper CRF
Participant monitoring No
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) publications
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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