Soft Tissue InjuriesAMPEDNCT01626235
AMPED Outcomes Registry of Post-ED Pain Management
An observational study of Soft Tissue Injuries and Gouty Arthritis, run by Radnor Registry Research, Inc at 11 sites in United States.
Trial summary
Study aims to assess patient-recorded outcomes of pain control medications prescribed in the ER after visits for specific painful injuries/illnesses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Injuries, Gouty Arthritis, Fractures
- How many people
- 843 participants
- Where
- 11 sitesUnited States
- Study dates
- Jul 2012to Mar 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: at least 800 patients with specific musculoskeletal or visceral pain syndrome
Who may be able to join
- Eligible subjects will meet the following criteria:
- Eligible diagnoses:
- musculoskeletal etiologies: acute extremity fractures sprains/strains acute gouty arthritis visceral etiologies: renal colic dysmenorrhea
- Age GTE 18 years;
- Decision to discharge from ED to community already made;
- Decision to give SPRIX, opioid, OR SPRIX + opioid rescue already made;
- Treating clinician deems patient appropriate for continued analgesic management as an outpatient for the next 3-5 days;
- Patient has ready touch-tone (mobile or land line) telephone access, provides number (and back-up number, if possible) and agrees (verbal or written consent as mandated by site) to answer and comply with brief IVR questionnaires daily for next 4 days.
Who cannot join
- Eligible subjects will meet none of the following criteria:
- Patient admitted or placed on observation status from ED;
- Patient unwilling or unable to comply with telephonic follow-up;
- Fracture that requires surgical repair (even if at a later date);
- Patient has diagnosis of any chronic pain syndrome;
- Patient already routinely takes NSAID or opioid agent;
- Treating clinician has reasonable suspicion of drug-seeking behavior or noncompliance;
- Nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Medical University of South Carolina
Charleston, South Carolina, 29403
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44106
Ben Taub General Hospital
Houston, Texas, 77030
University of Texas HSC at Houston
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
LSU Medical Center
New Orleans, Louisiana, 70112
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
University of Oklahoma HSC
Tulsa, Oklahoma, 74135
About this study
Official title: Acute Management of Pain From the Emergency Department: A National, Emergency Department-Based Prospective Post-Intervention Registry of Non-Opioid and Opioid Management of Acute Pain
Study aims to assess patient-recorded outcomes of pain control medications prescribed in the ER after visits for specific painful injuries/illnesses.
Read the detailed description
Multicenter, observational, prospective, out-of-hospital registry collecting clinical, satisfaction, quality of life, and healthcare resource utilization from subjects discharged after ED care for a specific acute pain syndrome with a clinician-determined analgesic regimen. Subjects are stratified by diagnosis and by regimen based on the treating clinician's judgment. The registry study is independent of ED care and clinician's decision-making.
- Conditions
- Soft Tissue Injuries, Gouty Arthritis, Fractures, Ureteral Colic, Dysmenorrhea
- Keywords
- pain control, fractures, sprains, strains, dysmenorrhea, kidney stones, gouty arthritis, opioids, NSDAIDs, Emergency Department, patient reported outcomes
- Medical subject headings
- Soft Tissue Injuries, Arthritis, Gouty, Fractures, Bone, Renal Colic, Dysmenorrhea, Agnosia, Sprains and Strains, Kidney Calculi
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 |
|---|---|---|
| NSAID only | Subjects have their pain treated post-ED care with NSAID medication alone | |
| Opioid only | Subjects have their pain treated post-ED care with opioid medication alone | |
| NSAID + Opioid | Subjects have their pain treated post-ED care with NSAID medication and opioid as PRN rescue analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcomes of pain control measures
- Change in pain score over follow-up interval;
- Healthcare resource utilization during follow-up interval;
- Patient satisfaction with therapy;
- Return to work in employed cohort.
Measured: 5 days
Secondary outcomes (1)
Satisfaction and Economic Outcomes
- Effectiveness of work upon return;
- Relative adverse effect profiles of three treatment regimens;
- Compliance with therapy;
- QOL at conclusion of therapy.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue InjuriesStudies 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
- Time perspective
- Prospective
- Enrolment
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radnor Registry Research, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American Regent, Inc.
- Responsible party
- Sponsor
- Investigators
- Charles V Pollack, MD, Principal investigator, University of PennsylvaniaKnox Todd, MD, Study director, MD AndersonDebra Diercks, MD, Study director, UC DavisSharon Mace, MD, Study director, The Cleveland ClinicStephen Thomas, MD, Study director, Univ Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626235
- Sponsor's protocol ID
- RRR-LUIT-01
- Acronym
- AMPED
- Status last verified
- Mar 2014
- First submitted
- 20 Jun 2012
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Management of Pain From the Emergency Department: A National, Emergency Department-Based Prospective Post-Intervention Registry of Non-Opioid and Opioid Management of Acute Pain
- ClinicalTrials.gov ID
- NCT01626235
- Acronym / sponsor ID
- AMPED / RRR-LUIT-01
- Conditions
- Soft Tissue Injuries, Gouty Arthritis, Fractures, Ureteral Colic, Dysmenorrhea
- Keywords
- pain control, fractures, sprains, strains, dysmenorrhea, kidney stones, gouty arthritis, opioids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- Radnor Registry Research, IncIndustry (pharma, biotech, devices)
- Collaborators
- American Regent, Inc.
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 22 Jun 2012 (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.
Study aims to assess patient-recorded outcomes of pain control medications prescribed in the ER after visits for specific painful injuries/illnesses.
Detailed description
Multicenter, observational, prospective, out-of-hospital registry collecting clinical, satisfaction, quality of life, and healthcare resource utilization from subjects discharged after ED care for a specific acute pain syndrome with a clinician-determined analgesic regimen. Subjects are stratified by diagnosis and by regimen based on the treating clinician's judgment. The registry study is independent of ED care and clinician's decision-making.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NSAID only | – | –Subjects have their pain treated post-ED care with NSAID medication alone |
| Opioid only | – | –Subjects have their pain treated post-ED care with opioid medication alone |
| NSAID + Opioid | – | –Subjects have their pain treated post-ED care with NSAID medication and opioid as PRN rescue analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- at least 800 patients with specific musculoskeletal or visceral pain syndrome
Key inclusion criteria (8 listed)
- Eligible subjects will meet the following criteria:
- musculoskeletal etiologies: acute extremity fractures sprains/strains acute gouty arthritis visceral etiologies: renal colic dysmenorrhea
Key exclusion criteria (8 listed)
- Eligible subjects will meet none of the following criteria:
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
Clinical Outcomes of pain control measures
Time frame: 5 days
1. Change in pain score over follow-up interval; 2. Healthcare resource utilization during follow-up interval; 3. Patient satisfaction with therapy; 4. Return to work in employed cohort.
1 secondary outcome
Satisfaction and Economic Outcomes
Time frame: 5 days
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 12 Mar 2014.
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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.
Charles V Pollack, MD principal investigator
University of Pennsylvania
Knox Todd, MD study director
MD Anderson
Debra Diercks, MD study director
UC Davis
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Injuries and Gouty Arthritis, run by Radnor Registry Research, Inc at 11 sites in United States.
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 8 inclusion and 8 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 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
Clinical Outcomes of pain control measures (time frame: 5 days). 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 12 Mar 2014.