drugset / Trial / NCT03529331

A Study Comparing Recurrent Use of MSIR, Percocet, and Vicodin at Discharge From the ED

NCT03529331 ↗

Phase 4 Withdrawn Antonios Likourezos
RandomizedSequentialQuadruple-blindTreatment

Summary

This is a prospective randomized, clinical trial comparing recurrent use of Morphine Sulfate Immediate Release (MSIR), Oxycodone/Acetaminophen (Percocet), and Hydrocodone/Acetaminophen (Vicodin) at discharge from the emergency department for opioid-naive adult patients presenting with moderate-to-severe pain. At discharge, patients will be randomized to receive either 5 mg of Oxycodone/Acetaminophen (Percocet) tablet 4 times a day for 5 days, 5 mg of Hydrocodone/Acetaminophen (Vicodin) tablet 4 times a day for 5 days, or 15 mg Morphine Sulfate Immediate Release (MSIR) tablet 4 times a day for 5 days. At 1 month, 3 months, and 6 months patients' prescription's history will be accessed by using the DoctorFirst Drug Database to determine the recurrent use that will serve as a surrogate marker of likeability and abuse liability of each prescribed opioid.

Timeline

Start
2019-09-01
Primary completion
2021-12-31
Completion
2021-12-31

Outcome

Outcome not reported

Stopped: “The ED physicians no longer prescribe opioids at discharge; not feasible to conduct the study”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydrocodone/Acetaminophen Unknown 5 mg —
Comparator Morphine Sulfate Immediate Release Unknown 15 mg —
Comparator Oxycodone/Acetaminophen Unknown 5 mg —

Indications

No indication recorded.