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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ciro Paolillo, Azienda Ospedaliera S. Maria della Misericordia
ClinicalTrials.gov Identifier:
NCT02046681
First received: January 9, 2014
Last updated: March 2, 2015
Last verified: June 2014
  Purpose

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
Acute Pain
Analgesics
Elderly

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: Monitoring Side Effects Of Pain Medication Prescribing By Emergency Department In Patients Over 65. The MOSE65 Study

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera S. Maria della Misericordia:

Primary Outcome Measures:
  • To measure side effects of pain medication prescribed by emergency department to patients older 65 years [ Time Frame: up to 1 week ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    July 1, 2014

  • Measure the number of patients that follow the therapy prescribed [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    July 1 2014


Estimated Enrollment: 1000
Study Start Date: June 2014
Study Completion Date: March 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

individuals age 65 years or older initiating analgesic treatment po following emergency department visits.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02046681

Locations
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, Italy, 33100
Sponsors and Collaborators
Azienda Ospedaliera S. Maria della Misericordia
Investigators
Study Chair: Ciro Paolillo, Dr AOU S.Maria della Misericordia Udine
  More Information

No publications provided

Responsible Party: Ciro Paolillo, Dr. Ciro Paolillo, Azienda Ospedaliera S. Maria della Misericordia
ClinicalTrials.gov Identifier: NCT02046681     History of Changes
Other Study ID Numbers: AOSMariaMisericordia
Study First Received: January 9, 2014
Last Updated: March 2, 2015
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Azienda Ospedaliera S. Maria della Misericordia:
Medication Adherence
Medication Compliance
Medication Therapy Management
Side effects
Analgesics
Emergency Medicine
Home care
Aged
Acetaminophen
codeine
ibuprofen
Oxycodone

Additional relevant MeSH terms:
Acute Pain
Emergencies
Disease Attributes
Nervous System Diseases
Neurologic Manifestations
Pain
Pathologic Processes
Signs and Symptoms
Analgesics
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 31, 2015