Acute PainMOSE65NCT02046681
Monitoring Side Effects Of Pain Medication Prescribing By Emergency Department In Patients Over 65
An observational study of Acute Pain and Analgesics, run by Azienda Ospedaliera S. Maria della Misericordia at 5 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Pain, Analgesics, Elderly
- How many people
- 1,000 participants
- Where
- 5 sitesItaly
- Study dates
- Jun 2014to Mar 2015
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: individuals age 65 years or older initiating analgesic treatment po following emergency department visits.
Who may be able to join
- 65 years or older
- new analgesic treatment po following emergency department visits
- easily reachable by phone
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Castelfranco Veneto Emergency Department
Castelfranco Veneto
Dolo Emergency Department
Dolo
Mirano Emergency Department
Mirano
Montebelluna Emergency Department
Montebelluna
Emergency Department AOU S.Maria della Midericordia Udine
Udine, Udine, 33100
About this study
Official title: 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.
Read the detailed description
- observe side effects of pain medications prescribed in emergency department to patient over 65 yo
- 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
- Medical subject headings
- Acute Pain, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 week
Secondary outcomes (2)
To ascertain the number of patients pain free
July 1, 2014
Measured: 1 month
Measure the number of patients that follow the therapy prescribed
July 1 2014
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera S. Maria della Misericordia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciro Paolillo, Azienda Ospedaliera S. Maria della Misericordia
- Investigators
- Ciro Paolillo, Dr, Study chair, AOU S.Maria della Misericordia Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046681
- Sponsor's protocol ID
- AOSMariaMisericordia
- Acronym
- MOSE65
- Status last verified
- Jun 2014
- First submitted
- 9 Jan 2014
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Side Effects Of Pain Medication Prescribing By Emergency Department In Patients Over 65. The MOSE65 Study
- ClinicalTrials.gov ID
- NCT02046681
- Acronym / sponsor ID
- MOSE65 / AOSMariaMisericordia
- Conditions
- Acute Pain, Analgesics, Elderly
- Keywords
- Medication Adherence, Medication Compliance, Medication Therapy Management, Side effects, Analgesics, Emergency Medicine, Home care, Aged
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera S. Maria della MisericordiaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- observe side effects of pain medications prescribed in emergency department to patient over 65 yo
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- individuals age 65 years or older initiating analgesic treatment po following emergency department visits.
Key inclusion criteria (3 listed)
- 65 years or older
- new analgesic treatment po following emergency department visits
- easily reachable by phone
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
To ascertain the number of patients pain free
Time frame: 1 month
Measure the number of patients that follow the therapy prescribed
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ciro Paolillo, Dr study chair
AOU S.Maria della Misericordia Udine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pain and Analgesics, run by Azienda Ospedaliera S. Maria della Misericordia at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure side effects of pain medication prescribed by emergency department to patients older 65 years (time frame: up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015.