- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02046681
Monitoring Side Effects Of Pain Medication Prescribing By Emergency Department In Patients Over 65 (MOSE65)
March 2, 2015 updated by: Ciro Paolillo, Azienda Ospedaliera S. Maria della Misericordia
Monitoring Side Effects Of Pain Medication Prescribing By Emergency Department In Patients Over 65. The MOSE65 Study
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.
Study Overview
Status
Completed
Conditions
Detailed Description
- observe side effects of pain medications prescribed in emergency department to patient over 65 yo
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Castelfranco Veneto, Italy
- Castelfranco Veneto Emergency Department
-
Dolo, Italy
- Dolo Emergency Department
-
Mirano, Italy
- Mirano Emergency Department
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Montebelluna, Italy
- Montebelluna Emergency Department
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Udine, Italy, 33100
- Emergency Department AOU S.Maria della Midericordia Udine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
individuals age 65 years or older initiating analgesic treatment po following emergency department visits.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To measure side effects of pain medication prescribed by emergency department to patients older 65 years
Time Frame: up to 1 week
|
To Measure the rate of mayor and minor complications and the number of hospitalization during the therapy
|
up to 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To ascertain the number of patients pain free
Time Frame: 1 month
|
July 1, 2014
|
1 month
|
Measure the number of patients that follow the therapy prescribed
Time Frame: 1 month
|
July 1 2014
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ciro Paolillo, Dr, AOU S.Maria della Misericordia Udine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
January 9, 2014
First Submitted That Met QC Criteria
January 27, 2014
First Posted (Estimate)
January 28, 2014
Study Record Updates
Last Update Posted (Estimate)
March 3, 2015
Last Update Submitted That Met QC Criteria
March 2, 2015
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOSMariaMisericordia
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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