R. Saggini et al., COMPARISON OF ELECTROMOTIVE DRUG ADMINISTRATION WITH KETOROLAC OR WITH PLACEBO IN PATIENTS WITH PAIN FROM RHEUMATIC DISEASE - A DOUBLE-MASKED STUDY, Clinical therapeutics, 18(6), 1996, pp. 1169-1174
This study was undertaken to assess the efficacy of ketorolac compared
with placebo when delivered by electromotive drug administration (EMD
A) in patients with pain from rheumatic disease. In EMDA, or iontophor
esis, a low-intensity electric current is applied over the skin to del
iver medication into body tissues. Although EMDA has been used to trea
t patients with various diseases, controlled studies are lacking in pa
tients with rheumatic disease. This double-masked study included 60 pa
tients (43 women and 17 men) aged 31 to 80 years with the following co
nditions: 12, epicondylitis; 30, scapulohumeral periarthritis; 10, gon
algia; and 8, metatarsalgia. They were divided randomly by a physician
into 2 groups of 30 patients each for 5 sessions of active treatment
(30 mg of ketorolac) or placebo (5 mL of normal saline). Treatment too
k place every other day for 20 minutes. Immediately before and after t
he five treatment sessions and 7 days after treatment ended, both pati
ent and physician measured the degree of pain using a categoric scale
(no pain, slight pain, intermediate pain, strong pain, and very strong
pain) and evaluated pain intensity using the Scott and Huskisson Visu
al Analogue Scale (VAS). Seven days after treatment ended, both physic
ian and patient judged the result of treatment using a second categori
c scale (no improvement or intermediate, good, or very good result), B
oth ketorolac and placebo provided immediate, significant pain relief
when delivered by EMDA, but only those patients receiving ketorolac ex
perienced a further reduction in pain 7 days after treatment; those re
ceiving placebo experienced a slight increase in pain. VAS values diff
ered significantly between the two groups. Poor results (no improvemen
t) were significantly higher in the placebo-treated group, while good
results were significantly higher in the ketorolac-treated group. No p
atient reported any adverse effects during treatment. This study demon
strates that ketorolac relieves pain when delivered by EMDA and offers
longer-lasting pain relief than does placebo.