Clinical trial NCT01626235: AMPED Outcomes Registry of Post-ED Pain Management
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 type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Radnor Registry Research, Inc
Sponsor class: INDUSTRY
Collaborators: name: American Regent, Inc.
First posted: 2012-06-22
Enrollment: 843
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: at least 800 patients with specific musculoskeletal or visceral pain syndrome

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Eligible subjects will meet the following criteria:

  1. Eligible diagnoses:

     musculoskeletal etiologies: acute extremity fractures sprains/strains acute gouty arthritis visceral etiologies: renal colic dysmenorrhea
  2. Age GTE 18 years;
  3. Decision to discharge from ED to community already made;
  4. Decision to give SPRIX, opioid, OR SPRIX + opioid rescue already made;
  5. Treating clinician deems patient appropriate for continued analgesic management as an outpatient for the next 3-5 days;
  6. 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.

Exclusion Criteria:

* Eligible subjects will meet none of the following criteria:

  1. Patient admitted or placed on observation status from ED;
  2. Patient unwilling or unable to comply with telephonic follow-up;
  3. Fracture that requires surgical repair (even if at a later date);
  4. Patient has diagnosis of any chronic pain syndrome;
  5. Patient already routinely takes NSAID or opioid agent;
  6. Treating clinician has reasonable suspicion of drug-seeking behavior or noncompliance;
  7. 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).

Primary outcomes:
measure: Clinical Outcomes of pain control measures
timeFrame: 5 days
Secondary outcomes:
measure: Satisfaction and Economic Outcomes
timeFrame: 5 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: New Orleans
country: United States
facility: LSU Medical Center
state: Louisiana
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Tulsa
country: United States
facility: University of Oklahoma HSC
state: Oklahoma
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas HSC at Houston
state: Texas
Study officials:
affiliation: University of Pennsylvania
name: Charles V Pollack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MD Anderson
name: Knox Todd, MD
role: STUDY_DIRECTOR
affiliation: UC Davis
name: Debra Diercks, MD
role: STUDY_DIRECTOR
affiliation: The Cleveland Clinic
name: Sharon Mace, MD
role: STUDY_DIRECTOR
affiliation: Univ Oklahoma
name: Stephen Thomas, MD
role: STUDY_DIRECTOR
References: