Abstract

NABAL, M.  and  CANAL, J.. Fentanyl oravescentes buccal tablets for episodic pain: review of clinical data. Rev. Soc. Esp. Dolor [online]. 2012, vol.19, n.1, pp.24-31. ISSN 1134-8046.

Objectives: to review the clinical literature on the oravescentes presentation of fentanyl buccal tablets with the aim of providing a critical view of published clinical data in breakthrough pain Methods: non systematic review of the literature published in Medline supplemented by manual search of related work and grey literature. Keywords: "Breakthrough pain" OR "Cancer pain" AND "Fentanyl buccal tablets" OR "Rapid onset opioids." Limits: Language: English or Spanish and studies in adults over 18 years. Inclusion criteria: clinical work with content related to the presentation of oral fentanyl "oravescente". Exclusion criteria referring to work pharmacokinetics or pharmacodynamics of the drug or its dosage, the work of general epidemiological nature and those that were not obtained in full text even though the query to several databases and national libraries. Results: from the 29 papers found, 12 studies were included following the inclusion and exclusion criteria. 4 were randomized double blind clinical trials, 1 was a multicenter open, 1 systematic review, 4 non-systematic reviews and 2 expert opinion papers. The four trials confirm that the analgesic effect is present 5 minutes after administration of the drug. There were significant differences with placebo since the 10 minutes till the 90 minutes. These differences kept stable for 2 hours. The Sum of Pain Intensity Differences (SPID) is favourable to the drug compared to placebo at 60 minutes after administration (p < 0.0001). It is noted that side effects mentioned were mild nausea (32%), vomiting (24%), asthenia (18%), constipation (15%) and headache (15%). No reference to neurocognitive changes at times of peak plasma concentration or behaviors of addiction or abuse were detected. The non systematic reviews offer the expert insight on the treatment of breakthrough pain with an independent position. They criticized the inclusion criteria of randomized trials for introducing significant bias in the sample selection and the lack of oral fentanyl compared with standard treatments available. Conclusions: fentanyl tablets "oravescentes" have proven more effective than placebo in the episodic pain caused by cancer or other diseases. The analgesic effects appear within 10 minutes of administration although the peak plasma concentration is reached at the time. Side effects are generally mild and not always motivated by the treatment. It is needed long-term studies to confirm the encouraging data currently available.

Keywords : Fentanyl buccal tablets; Breakthrough pain; Cancer pain; Review.

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