Fentanyl buccal tablet versus oral oxycodone for Emergency Department treatment of musculoskeletal pain

Abstract

Background: Emergency Department (ED) analgesia can potentially be delivered quickly using transbuccal administration. A previous study identified time-of-onset advantage of a 100 mcg fentanyl buccal tablet (FBT) as compared to a dose of 5 mg oxycodone with 325 mg acetaminophen. The current study reports comparison of higher-dose (200 mcg) FBT as compared to a more commonly used oxycodone dose of 10 mg with 650 mg acetaminophen. Methods: Time frame: Patients were enrolled between October 2012 and October 2014. Setting: The study was conducted in an urban teaching ED with annual census of 55,000. Patients: The 50 convenience-sampled cases met eligibility criteria of age 18-60, with isolated orthopedic complaints; subjects required X-ray to rule-out fracture, and to have pain sufficient to warrant opioids. Interventions: In this double-blind placebo-controlled analgesia trial, patients were randomized to one of two study groups. OXY subjects received two orally ingested tablets, each containing 5 mg oxycodone and 325 mg acetaminophen, and a transbuccal inactive comparator. FBT subjects received two placebo oral tablets and a 200 mcg FBT. Data: The main study endpoint was achievement of at least two points' reduction in numeric pain rating scale (NPRS) within ten minutes of study drug administration. NPRS was assessed at the time of study entry and every five minutes' post-drug administration for an hour. Secondary endpoints included assessment of side effects and subjects' desire to have the same medication for future similar pain. Analysis: Categorical data were assessed with binomial exact 95% confidence intervals (CIs). Continuous data, after being demonstrated as non-normal with skewness-kurtosis testing, were analyzed with Kruskal-Wallis testing. Multivariate Cox proportional hazards analysis was performed to assess whether, after adjustment for potential confounders, there was a difference between FBT and OXY groups with respect to time to achieving significant analgesia. Results: Study groups were similar with respect to age (medians: OXY 34, FBT 38, p = 0.47), initial pain score (median 8 in each group), sex (proportion of males: OXY 64%, FBT 48%, p = 0.25), and ethnicity (proportion of whites: OXY 68%, FBT 56%, p = 0.38). The same proportion (52%) of OXY and FBT cases achieved significant reduction in pain within 15 minutes. Multivariate Cox regression adjusting for potential confounders confirmed (p = 0.28) no difference in rates of pain reduction between OXY and FBT. There were no major complications in either group. The majority of subjects in each group (80% in FBT group versus 76% in OXY group, p = 0.73) expressed high satisfaction and preference to receive the same regimen in future. Conclusion: This study's results suggest approximate equivalence between 200 mcg FBT and 10 mg oxycodone with 650 mg acetaminophen, with respect to time-to-analgesia, analgesic efficacy, side effects, and patient satisfaction.