NCT03173456

Comparing Five Oral Analgesics for Treatment of Acute Pain in the Emergency Department (ED)

Comparing the Efficacy of Five Oral Analgesics for Treatment of Acute Musculoskeletal Extremity Pain in the Emergency Department

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 21 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study compares the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen, 400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for the treatment of patients with acute musculoskeletal pain who present to the Emergency Department (ED).

Detailed description

The optimal treatment of musculoskeletal extremity pain in the ED not known. The study is a randomized controlled trial designed to compare the efficacy of five oral analgesics: 5 mg oxycodone + 325 mg acetaminophen, 5 mg hydrocodone + 300 mg acetaminophen, 30 mg codeine + 300 mg acetaminophen, 400 mg ibuprofen + 1000 mg acetaminophen, and 800 mg ibuprofen + 1000 mg acetaminophen for the treatment of patients with acute musculoskeletal pain. The primary outcome is the between treatment group difference in change in patients' rating of pain intensity one hour after ingestion of the study medication. Secondary outcomes include: 1) the between treatment group difference in change in patients' rating of pain intensity two hours after ingestion of the study medication; 2) difference in proportion of patients who receive rescue medication; 3) difference in proportion of patients who would choose to take the study medication again if they returned to the ED with similar pain; 4) difference in proportion of patients who experience side effects.

Conditions

• Musculoskeletal Pain

Interventions

Type	Name	Description
DRUG	oxycodone/APAP	Oxycodone/acetaminophen 5 mg-325 mg oral tablet
DRUG	hydrocodone/APAP	Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet
DRUG	codeine/APAP	Codeine/acetaminophen 30 mg-300mg oral tablet
DRUG	400 ibuprofen/APAP	ibuprofen/acetaminophen 400 mg-1000mg oral tablet
DRUG	800 ibuprofen/APAP	ibuprofen/acetaminophen 800 mg-1000 mg oral tablet

Timeline

• Start date: 2017-11-28
• Primary completion: 2019-11-14
• Completion: 2019-11-14
• First posted: 2017-06-01
• Last updated: 2022-02-01
• Results posted: 2022-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study