Advertisement

The efficacy of oral piroxicam fast-dissolving tablets versus sublingual fentanyl in incident breakthrough pain due to bone metastases: a double-blinded randomized study

  • Ayman Abdalmaksoud Yousef
  • Ashraf Elsayed Alzeftawy
Original Article
  • 26 Downloads

Abstract

Purpose

Breakthrough pain (BTP) is a transient exacerbation of pain occurring in a patient with chronic, persistent pain. The most common type is incident pain that is mostly related to bone metastases. The oral mucosa is an attractive route for drug delivery. Sublingual fentanyl preparations are a very attractive agent in controlling attacks of BTP due to its rapid absorption through the oral mucosa. Non-steroidal anti-inflammatory drugs (NSAIDs) play a key role as a first step in treatment of cancer pain; piroxicam sublingual formulations could be a useful alternative in controlling incident pain. Our study hypothesis is to evaluate the efficacy of sublingual fentanyl versus oral piroxicam fast-dissolving tablets in patients with incident pain and its impact on functional status.

Patients and methods

A cohort of 100 adults of both genders suffering from bone metastases. Patients were assigned to receive either sublingual fentanyl tablet (group 1) or oral piroxicam fast-dissolving tablets (group 2). The pain intensity reduction on a 0–10 visual analog scale (VAS), frequency of BTP attacks, and onset of pain relief. Secondary end points included the functional interference items of the Brief Pain Inventory (BPI).

Results

There is no significant difference between the two groups regarding the patients’ demographics. Significant decline of the VAS in each group in comparison to the pretreatment values (p = 0.001). Non-significant changes of the VAS, duration of pain attacks, and number of rescue doses in comparing both groups were measured. There was significant reduction in group 2 BPI regarding the relation with others, sleep pattern and enjoyment of life parameters at 2 and 4 weeks (p = 0.001).

Conclusion

Our study demonstrated that oral piroxicam fast-dissolving tablet is an analgesic alternative to sublingual fentanyl in patients with bone metastasis to control incidental BTP attacks with more favorable cost-benefit values.

Keywords

Oral piroxicam tablets Sublingual fentanyl Incident BTP Bone metastases 

Notes

Acknowledgments

The authors would like to thank the hospital pharmacist and the nursing staff of the pain clinic who participated in the study; in addition, we thank Prof Ibrahem Al-kabbash, our study statistician.

Compliance with ethical standards

The study was approved by an Investigational Review Board of the Faculty of Medicine, Tanta University; an informed written consent was obtained from all patients participating in the study. This study was registered in the clinical trials registry (clinicaltrials.gov) with a unique identification number NCT02382653.

Conflict of interest

The authors declare that they have no conflict of interest.

References

  1. 1.
    Margarit C, Juliá J, López R, Anton A, Escobar Y, Casas A, Cruz JJ, Galvez R, Mañas A, Zaragozá F (2012) Breakthrough cancer pain– still a challenge. J Pain Res 5:559–566CrossRefPubMedPubMedCentralGoogle Scholar
  2. 2.
    Mishra S, Bhatnagar S, Chaudhary P, Pratap S, Rana S (2009) Breakthrough cancer pain: review of prevalence, characteristics and management. Indian Journal of Palliative Care 15(1):14–18CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Patel VF, Liu F, Brown MB (2011) Advances in oral transmucosal drug delivery. J Control Release 153:106–116CrossRefPubMedGoogle Scholar
  4. 4.
    Lennernäs B, Frank-Lissbrant I, Lennernäs H, Kälkner KM, Derrick R, Howell J (2010) Sublingual administration of fentanyl to cancer patients is an effective treatment for breakthrough pain; results from a randomized phase II study. Palliat Med 24:286–293CrossRefPubMedGoogle Scholar
  5. 5.
    Omoti AE, Omoti CE (2007) Pharmacological strategies for the management of cancer pain in developing countries. Pharm Pract 5(3):99–104Google Scholar
  6. 6.
    Kuo KL, Saokaew S, Stenehjem DD (2013) The pharmacoeconomics of breakthrough cancer pain. J Pain Palliat Care Pharmacother 27(2):167–175CrossRefPubMedGoogle Scholar
  7. 7.
    Mercadante S, Radbruch L, Caraceni A, Cherny N, Kaasa S, Nauck F, Ripamonti C, De Conno F (2002) Episodic (breakthrough) pain consensus conference of an expert working group of the European Association for Palliative Care. Cancer 94:832–839CrossRefPubMedGoogle Scholar
  8. 8.
    Mercadante S, Villari P, Ferrera P, Casuccio A (2004b) Optimization of opioid therapy for preventing incident pain associated with bone metastases. J Pain Symptom Manag 28:505–510CrossRefGoogle Scholar
  9. 9.
    San K, Carla MB, Sheri LD, Jeff S, Tito RM, Charles SC (2004) Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 20(5):309–318CrossRefGoogle Scholar
  10. 10.
    Zhang H, Zhang J, Streisand JB (2002) Oral mucosal drug delivery: clinical pharmacokinetics and therapeutic applications. Clin Pharmacokinet 41:661–680CrossRefPubMedGoogle Scholar
  11. 11.
    Payne R (1997) Mechanisms and management of bone pain. Cancer Supplement 80(8):1608–1613CrossRefGoogle Scholar
  12. 12.
    Yalcin S, Altundag K, Asil M, Tekuzman G (1998) Sublingual piroxicam for cancer pain. Med Oncol 15:137–139CrossRefPubMedGoogle Scholar
  13. 13.
    Gَmez-Batiste X, Madrid F, Moreno F, Gracia A, Trelis J, Nabal M et al (2002) Breakthrough cancer pain: prevalence and characteristics in patients in Catalonia, Spain. J Pain Symptom Manag 24:45–52CrossRefGoogle Scholar
  14. 14.
    Davies AN, Vriens J, Kennett A, McTaggart M (2008) An observational study of oncology patients’ utilisation of breakthrough pain medication. J Pain Symptom Manag 35(4):406–411CrossRefGoogle Scholar
  15. 15.
    Janecki M, Janecka J (2011) Breakthrough pain in patients with chronic cancer pain followed by palliative care and pain clinic physicians — an observational study. Palliat Med 10(1):29–34Google Scholar
  16. 16.
    Rauck RL, Tark M, Reyes E, Hayes TG, Bartkowiak AJ, Hassman D, Nalamachu S, Derrick R, Howell J (2009) Efficacy and long-term tolerability of sublingual fentanyl orally disintegrating tablet in the treatment of breakthrough cancer pain. Curr Med Res Opin 25(12):2877–2885CrossRefPubMedGoogle Scholar
  17. 17.
    Smith HS (2013) Considerations in selecting rapid-onset opioids for the management of breakthrough pain. J Pain Res 6:189–200CrossRefPubMedPubMedCentralGoogle Scholar
  18. 18.
    Chwieduk CM, McKeage K (2010) Fentanyl sublingual: in breakthrough pain in opioid-tolerant adults with cancer. Drugs 70(17):2281–2288CrossRefPubMedGoogle Scholar
  19. 19.
    Überall MA, Müller-Schwefe GH (2011) Sublingual fentanyl orally disintegrating tablet in daily practice: efficacy, safety and tolerability in patients with breakthrough cancer pain. Curr Med Res Opin 27(7):1385–1394CrossRefPubMedGoogle Scholar
  20. 20.
    Lister N, Warrington S, Boyce M, Eriksson C, Tamaoka M, Kilborn J (2011) Pharmacokinetics, safety, and tolerability of ascending doses of sublingual fentanyl, with and without naltrexone, in Japanese subjects. J Clin Pharmacol 51(8):1195–1204CrossRefPubMedGoogle Scholar
  21. 21.
    Jandhyala R, Fullarton JR, Bennett MI (2013) Efficacy of rapid-onset oral fentanyl formulations vs. oral morphine for cancer-related breakthrough pain: a meta-analysis of comparative trials. J Pain Symptom Manag 12:1–8Google Scholar
  22. 22.
    Shimoyama N, Gomyo I, Teramoto O, Kojima K, Higuchi H, Yukitoshi N, Ohta E, Shimoyama M (2015) Efficacy and safety of sublingual fentanyl orally disintegrating tablet at doses determined from oral morphine rescue doses in the treatment of breakthrough cancer pain. Jpn J Clin Oncol 45(2):189–196CrossRefPubMedGoogle Scholar
  23. 23.
    Davies AN, Dickman A, Reid C, Stevens AM, Zeppetella G (2009) The management of cancer-related breakthrough pain: recommendations of a task group of the Science Committee of the Association for Palliative Medicine of Great Britain and Ireland. Eur J Pain 13:331–338CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Pain Unit, Anesthesia Department, Faculty of MedicineTanta UniversityTantaEgypt

Personalised recommendations