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418 THE CLINICAL AND LABORATORIAL EVALUATION OF TRANSDERMAL KETAMINE, FENTANYL, CLONIDINE OR THEIR COMBINATION IN CHRONIC LOW BACK PAIN
Author(s) -
Lauretti G.R.,
Mattos A.L.,
Lima I.C.P.R.,
Matsumoto M.,
Resende C.S.
Publication year - 2009
Publication title -
european journal of pain
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.305
H-Index - 109
eISSN - 1532-2149
pISSN - 1090-3801
DOI - 10.1016/s1090-3801(09)60421-3
Subject(s) - transdermal , medicine , pharmacology
Background and Objectives: Clinical experience suggests a role for botulinum toxin type A (TXB-A) in headache. However, there is no report regarding conversion factor between Botox and Prosigne. The objective was to evaluate the safety and efficacy of the two available preparations of TXB-A. Methods: 40 patients with chronic daily headache were randomized into 4 groups and double-blinded evaluated. Patients received either im 25UI Botox (Botox group); 25UI Prosigne (25-Pro group); 33.3UI Prosigne (33-Pro group) or saline (Control group). Pain and adverse effects were evaluated: 1) prior to TXB-A; 2) 28 days after the TXB-A or saline; and 3) 56 days after the TXB-A or saline application. Results: The conversion factor between Botox and Prosigne was 1:1.3. Both 25UI Botox and 33.3UI Prosigne resulted in approximately seven headache-free days compared to baseline at 28and 56-day evaluation. Patients experienced a 50% or more decrease in the frequency of headache days, in addition to significant reductions in headache intensity, with only transient adverse effects. Conclusions: The conversion factor between Botox and Prosigne was 1:1.3. The dose of 25UI Botox was similar to 33.3UI Prosigne regarding efficacy and adverse effects in chronic daily headache.