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

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
      • Montebelluna, Italy
        • Montebelluna Emergency Department
      • 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

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.

Clinical Trials on Acute Pain

3
Subscribe