Status:
TERMINATED
Relieving Acute Pain (RAP) Study: A Pilot Study
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Trauma
Opioid Use
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The United States (US) faces a crisis of pain management. According to the 2012 National Health Interview Survey, almost 50 million adults in the US reported having significant chronic or severe pain ...
Detailed Description
Overview: We will screen 500 patients from the Shock Trauma Center to recruit a total of 159 (53 per arm) to participate in a pilot study aimed at reducing use of opioids. Participants will meet all ...
Eligibility Criteria
Inclusion
- Age 18-65
- Admission to The Shock Trauma Center within 72 hrs
- Any trauma requiring inpatient opioid medication
- Plan by primary service to follow the Shock Trauma Guidelines for Acute Pain in Orthopedic Injury
- Predicted length of stay greater than or equal to 2 days
Exclusion
- Non English speaking
- Spine cord injury
- Severe Traumatic brain injury (based on a Glascow Coma Scale of 8 or less)
- Patient-controlled analgesia
- Admission Creatinine \> 1.4
- History of chronic kidney disease
- Heroin use in the 3 months prior to admission (patient self-report)
- Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, mania, autism) and /or psychiatric condition leading to treatment and/or hospitalization within the last 1 year.
- Positive toxicology screen for methadone not prescribed during current hospitalization
- Pregnancy or breast feeding
- Contraindication to NSAIDs, including high risk of bleeding or known severe coronary artery disease
- Injuries deemed non survival.
Key Trial Info
Start Date :
September 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03426137
Start Date
September 17 2018
End Date
January 21 2020
Last Update
April 27 2021
Active Locations (1)
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1
University of Maryland
Baltimore, Maryland, United States, 21201-1512