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

NCT02046681 | Completed DMC

• 1 other identifier: AOSMariaMisericordia
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Acute Pain; Analgesics; Elderly

Keywords

Medication Adherence; Medication Compliance; Medication Therapy Management; Side effects; Analgesics; Emergency Medicine; Home care; Aged; Acetaminophen; codeine; ibuprofen; Oxycodone

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• To ascertain the number of patients pain free

  1 month

• Measure the number of patients that follow the therapy prescribed

  1 month

Study Arms (1)

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• years or older
• new analgesic treatment po following emergency department visits
• easily reachable by phone

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera S. Maria della Misericordia: lead

Study Sites (5)

Emergency Department AOU S.Maria della Midericordia Udine

Udine, Udine, 33100, Italy

Location

Castelfranco Veneto Emergency Department

Castelfranco Veneto, Italy

Location

Dolo Emergency Department

Dolo, Italy

Location

Mirano Emergency Department

Mirano, Italy

Location

Montebelluna Emergency Department

Montebelluna, Italy

Location

MeSH Terms

Conditions

Acute Pain; Medication Adherence

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ciro Paolillo, Dr

  AOU S.Maria della Misericordia Udine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ciro Paolillo

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 28, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: March 3, 2015

Record last verified: 2014-06

Locations

IT (5)