1887
Volume 2015, Issue 1
  • ISSN: 1999-7086
  • EISSN: 1999-7094

Abstract

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. : Patients were enrolled between October 2012 and October 2014.

: The study was conducted in an urban teaching ED with annual census of 55,000.

: 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.

: 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.

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.

: 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. 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. 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.

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2015-06-20
2020-09-23
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References

  1. Wilson JE, Pendleton JM. Oligoanalgesia in the emergency department. Am J Emerg Med. 1989; 7::620623.
    [Google Scholar]
  2. Grant PS. Analgesia delivery in the ED. Am J Emerg Med. 2006; 24::806809.
    [Google Scholar]
  3. Arthur AO, Holder P. A review of transbuccal fentanyl use in the emergency department. Pain research and treatment. 2012; 2012::768796.
    [Google Scholar]
  4. Thomas SH, Shewakramani S. Prehospital trauma analgesia. J Emerg Med. 2008; 35::4757.
    [Google Scholar]
  5. Portenoy RK, Messina J, Xie F, Peppin J. Fentanyl buccal tablet (FBT) for relief of breakthrough pain in opioid-treated patients with chronic low back pain: a randomized, placebo-controlled study. Curr Med Res Opin. 2007; 23::223233.
    [Google Scholar]
  6. Shear ML, Adler JN, Shewakramani S, Ilgen J, Soremekun OA, Nelson S, Thomas SH. Transbuccal fentanyl for rapid relief of orthopedic pain in the ED. Am J Emerg Med. 2010; 28::847852.
    [Google Scholar]
  7. Kotwal RS, O'Connor KC, Johnson TR, Mosely DS, Meyer DE, Holcomb JB. A novel pain management strategy for combat casualty care. Ann Emerg Med. 2004; 44::121127.
    [Google Scholar]
  8. Tammaro S, Berggren U, Bergenholtz G. Representation of verbal pain descriptors on a visual analogue scale by dental patients and dental students. Eur J Oral Sci. 1997; 105::207212.
    [Google Scholar]
  9. Todd K. Patient-oriented outcome measures: The promise of definition. Ann Emerg Med. 2001; 38::672674.
    [Google Scholar]
  10. Todd K, Funk K, Funk J, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996; 4::485490.
    [Google Scholar]
  11. Vassiliadis J, Hitos K, Hill C. Factors influencing prehospital and emergency department analgesia administration to patients with femoral neck fractures. Emerg Med (Freemantle, West Aust). 2002; 14::261266.
    [Google Scholar]
  12. DeVellis P, Thomas SH, Wedel SK. Prehospital and emergency department analgesia for air-transported patients with fractures. Prehosp Emerg Care. 1998; 2::293296.
    [Google Scholar]
  13. Manning BJ, O'Brien N, Aravindan S, Cahill RA, McGreal G, Redmond HP. The effect of aspirin on blood loss and transfusion requirements in patients with femoral neck fractures. Injury. 2004; 35::121124.
    [Google Scholar]
  14. Giannoidis P, Furlong A, Macdonald D, deBoer P, Smith R. Non-union of the femoral diaphysis: The influence of reaming and non-steroidal anti-inflammatory drugs (NSAIDs). J Bone Joint Surg. 2000; 82B::655658.
    [Google Scholar]
  15. Ducasse JL, Siksik G, Durand-Bechu M, Couarraze S, Vallé B, Lecoules N, Marco P, Lacombe T, Bounes V. Nitrous Oxide for Early Analgesia in the Emergency Setting: A Randomized, Double-blind Multicenter Prehospital Trial. Acad Emerg Med. 2013; 20::178184.
    [Google Scholar]
  16. Kober A, Scheck T, Greher M, Lieba F, Rleischhackl R. Prehospital analgesia with acupressure in victims of minor trauma: A prospective, randomized, double-blinded trial. Anesth Analg. 2002; 95::723727.
    [Google Scholar]
  17. Bendall JC, Simpson PM, Middleton PM. Effectiveness of prehospital morphine, fentanyl, and methoxyflurane in pediatric patients. Prehosp Emerg Care. 2011; 15::158165.
    [Google Scholar]
  18. Babl F, Barnett P, Palmer G, Oakley E, Davidson A. A pilot study of inhaled methoxyflurane for procedural analgesia in children. Paediatr Anaesth. 2007; 17::148153.
    [Google Scholar]
  19. Thronaes M, Kaasa S, Dale O. A pilot study of nasal fentanyl for patient controlled treatment of cancer pain. J Opioid Manag. 2014; 10::2128.
    [Google Scholar]
  20. Karlsen AP, Pedersen DM, Trautner S, Dahl JB, Hansen MS. Safety of intranasal fentanyl in the out-of-hospital setting: a prospective observational study. Ann Emerg Med. 2014; 63::699703.
    [Google Scholar]
  21. Lotsch J, Walter C, Parnham MJ, Oertel BG, Geisslinger G. Pharmacokinetics of non-intravenous formulations of fentanyl. Clin Pharmacokinet. 2013; 52::2336.
    [Google Scholar]
  22. Wedmore IS, Kotwal RS, McManus JG, Pennardt A, Talbot TS, Fowler M, McGhee L. Safety and efficacy of oral transmucosal fentanyl citrate for prehospital pain control on the battlefield. J Trauma Acute Care Surg. 2012; 73::S490S495.
    [Google Scholar]
  23. Thomas SH. Fentanyl in the prehospital setting. Am J Emerg Med. 2007; 25::842843.
    [Google Scholar]
  24. Mystakidou K, Katsouda E, Parpa E, Vlahos L, Tsiatas ML. Oral transmucosal fentanyl citrate: overview of pharmacological and clinical characteristics. Drug Deliv. 2006; 13::269276.
    [Google Scholar]
  25. Darwish M, Tempero K, Kirby M, Thompson J. Relative bioavailability of the fentanyl effervescent buccal tablet (FEBT) 1,080 pg versus oral transmucosal fentanyl citrate 1,600 pg and dose proportionality of FEBT 270 to 1,300 microg: a single-dose, randomized, open-label, three-period study in healthy adult volunteers. Clin Ther. 2006; 28::715724.
    [Google Scholar]
  26. Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Academic Emergency Medicine. 2003; 10::390392.
    [Google Scholar]
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  • Article Type: Research Article
Keyword(s): analgesia , emergency department , fentanyl , oxycodone and transbuccal
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