Monitoring Side Effects Of Pain Medication Prescribing By... | NCT02046681

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

NCT02046681

Sponsor

Azienda Ospedaliera S. Maria della Misericordia

Status

Completed

Last Update Posted

Mar 3, 2015Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Acute Pain
Analgesics
Elderly

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Mar 2015Actual

First Submitted Date

Jan 9, 2014

First Submission Date that Met QC Criteria

Jan 27, 2014

First Posted Date

Jan 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2015

Last Update Posted Date

Mar 3, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ciro Paolillo, Dr. Ciro Paolillo, Azienda Ospedaliera S. Maria della MisericordiaPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera S. Maria della MisericordiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
To ascertain the number of patients pain free	July 1, 2014	1 month
Measure the number of patients that follow the therapy prescribed	July 1 2014

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ciro Paolillo, Dr	AOU S.Maria della Misericordia Udine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emergency Department AOU S.Maria della Midericordia Udine		Udine	Udine	33100	Italy
Castelfranco Veneto Emergency Department

Condition Browse Module

MeSH Terms

ID	Term
D059787	Acute Pain
D055118	Medication Adherence

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided