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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02046681
Other study ID # AOSMariaMisericordia
Secondary ID
Status Completed
Phase N/A
First received January 9, 2014
Last updated March 2, 2015
Start date June 2014
Est. completion date March 2015

Study information

Verified date June 2014
Source Azienda Ospedaliera S. Maria della Misericordia
Contact n/a
Is FDA regulated No
Health authority Italy: The Italian Medicines Agency
Study type Observational [Patient Registry]

Clinical Trial Summary

Half of the people over the age of 65 are not functioning at their optimal level because of interference from pain. > 50% of older adults had taken prescriptions of pain medication beyond a 6-month period. In Emergency Department 80% of visits involving conditions with painful component. The study aims to observe and check side effects of most frequently pain killers prescribing at home to patients over 65 years old after a visit in emergency department.


Description:

- observe side effects of pain medications prescribed in emergency department to patient over 65 yo


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date March 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- 65 years or older

- new analgesic treatment po following emergency department visits

- easily reachable by phone

Exclusion Criteria:

- age under 65

- pt may not able to hear, or answer the phone

- pt with a history of dementia

- pt who already takes pain killer, or neuroleptics

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Castelfranco Veneto Emergency Department Castelfranco Veneto
Italy Dolo Emergency Department Dolo
Italy Mirano Emergency Department Mirano
Italy Montebelluna Emergency Department Montebelluna
Italy Emergency Department AOU S.Maria della Midericordia Udine Udine

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera S. Maria della Misericordia

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary To measure side effects of pain medication prescribed by emergency department to patients older 65 years To Measure the rate of mayor and minor complications and the number of hospitalization during the therapy up to 1 week Yes
Secondary To ascertain the number of patients pain free July 1, 2014 1 month No
Secondary Measure the number of patients that follow the therapy prescribed July 1 2014 1 month Yes
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