MOSE65: Monitoring Side Effects Of Pain Medication Prescribing By Emergency Department In Patients Over 65

Sponsor

Azienda Ospedaliera S. Maria della Misericordia (Other)

Overall Status

Completed

CT.gov ID

NCT02046681

Collaborator

(none)

1,000

Enrollment

Locations

Duration (Months)

200

Patients Per Site

22.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pain Analgesics Elderly

Detailed Description

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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Monitoring Side Effects Of Pain Medication Prescribing By Emergency Department In Patients Over 65. The MOSE65 Study

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Acetam, acetam + codeine, Ibuprofen, Oxycodone monitoring side effects of pain medication prescribed in patients over 65 acetaminophen 1000 mg tabs po q6h acetaminophen + codeine 500 mg tabs po q6h ibuprofen 200 mg tabs po q8h oxycodone 5 mg tabs po bid

Outcome Measures

Primary Outcome Measures

To measure side effects of pain medication prescribed by emergency department to patients older 65 years [up to 1 week]
To Measure the rate of mayor and minor complications and the number of hospitalization during the therapy

Secondary Outcome Measures

To ascertain the number of patients pain free [1 month]
July 1, 2014
Measure the number of patients that follow the therapy prescribed [1 month]
July 1 2014

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Castelfranco Veneto Emergency Department	Castelfranco Veneto	Italy
2	Dolo Emergency Department	Dolo	Italy
3	Mirano Emergency Department	Mirano	Italy
4	Montebelluna Emergency Department	Montebelluna	Italy
5	Emergency Department AOU S.Maria della Midericordia Udine	Udine	Italy	33100