Marzieh Fathi1, Mohammad Amin Zare2, Hamid Reza Bahmani2, Shahriar Zehtabchi3. 1. Emergency Medicine Department, Rasoul Akram Hospital, Tehran, Iran. Electronic address: marziehfathi@yahoo.com. 2. Emergency Medicine Department, Rasoul Akram Hospital, Tehran, Iran. 3. Emergency Medicine Department, State University of New York Downstate Medical Center, Brooklyn, NY.
Abstract
OBJECTIVES: This randomized clinical trial compares the efficacy and safety of oral oxycodone (an oral opioid) with naproxen (a nonsteroidal anti-inflammatory drug) in acute pain control in patients with soft tissue injury. It also evaluates the need for additional doses of analgesics in the first 24 hours of discharge from emergency department (ED). METHODS:Adult (>18 years old) patients with soft tissue injuries were enrolled in a teaching urban ED. Subjects were randomly allocated to receive a single dose of oral oxycodone (5 mg) or oral naproxen (250 mg). Pain scores and drugs' adverse effects were assessed before, 30 minutes, and 60 minutes after medication. OUTCOME: efficacy in pain control (reduction in pain scale >2 points) and safety (rate of side effects). The need for additional pain medication after discharge was assessed by follow-up phone call 24 hours after discharge. RESULTS: A total of 150 patients were enrolled. Pain scores were similar in oxycodone vs naproxen groups before (6.21 ± 0.9 in vs 6.0 ± 1.0), 30 minutes (4.5 ± 1.4 vs 4.4 ± 1.2), and 60 minutes (2.5 ± 1.3 in vs 2.6 ± 1.3) after medication, respectively. Twelve (16.0%) patients in oral oxycodone group and 5 (6.6%) patients in naproxen group needed more analgesics in first 24 hours after ED discharge. Adverse effects were more common in oxycodone group (statistically significant difference). The most common adverse effects in oxycodone group were nausea, (13.3%); vomiting, (8.0%); dizziness, (5.3%); drowsiness, 3 (4.0%); and pruritis, (2.7%). CONCLUSION:Oral oxycodone is as effective as naproxen in soft tissue injury pain control but has a less favorable safety profile.
RCT Entities:
OBJECTIVES: This randomized clinical trial compares the efficacy and safety of oral oxycodone (an oral opioid) with naproxen (a nonsteroidal anti-inflammatory drug) in acute pain control in patients with soft tissue injury. It also evaluates the need for additional doses of analgesics in the first 24 hours of discharge from emergency department (ED). METHODS: Adult (>18 years old) patients with soft tissue injuries were enrolled in a teaching urban ED. Subjects were randomly allocated to receive a single dose of oral oxycodone (5 mg) or oral naproxen (250 mg). Pain scores and drugs' adverse effects were assessed before, 30 minutes, and 60 minutes after medication. OUTCOME: efficacy in pain control (reduction in pain scale >2 points) and safety (rate of side effects). The need for additional pain medication after discharge was assessed by follow-up phone call 24 hours after discharge. RESULTS: A total of 150 patients were enrolled. Pain scores were similar in oxycodone vs naproxen groups before (6.21 ± 0.9 in vs 6.0 ± 1.0), 30 minutes (4.5 ± 1.4 vs 4.4 ± 1.2), and 60 minutes (2.5 ± 1.3 in vs 2.6 ± 1.3) after medication, respectively. Twelve (16.0%) patients in oral oxycodone group and 5 (6.6%) patients in naproxen group needed more analgesics in first 24 hours after ED discharge. Adverse effects were more common in oxycodone group (statistically significant difference). The most common adverse effects in oxycodone group were nausea, (13.3%); vomiting, (8.0%); dizziness, (5.3%); drowsiness, 3 (4.0%); and pruritis, (2.7%). CONCLUSION: Oral oxycodone is as effective as naproxen in soft tissue injury pain control but has a less favorable safety profile.
Authors: Daniel M Walker; Janet E Childerhose; Sadie Chen; Nicolette Coovert; Rebecca D Jackson; Natasha Kurien; Ann Scheck McAlearney; Jaclyn Volney; Daniel P Alford; Julie Bosak; Douglas R Oyler; Laura K Stinson; Melika Behrooz; Mia-Cara Christopher; Mari-Lynn Drainoni Journal: Drug Alcohol Depend Date: 2022-02-02 Impact factor: 4.492