ITMO public health
Last update : 01/01/2018 | Version : 1 | ID : 126
| 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 |
| 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 |
| 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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