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Abstract
The analgesic effectiveness of ketorolac tromethamine was compared with hydrocodone
and acetaminophen for pain from an arthroscopically assisted patellar-tendon autograft
anterior cruciate ligament reconstruction. There were 125 patients evaluated in a
double-blind, randomized, multicenter, and multidose study. A loading dose of parental
ketorolac tromethamine was administered and subjects were later given two staged doses
of the same "unknown" drug with pain evaluations conducted after each dose. For group
1, dose 1 consisted of ketorolac tromethamine 20 mg orally and dose 2 was ketorolac
tromethamine 10 mg. For group 2, both dose 1 and dose 2 consisted of hydrocodone 10
mg plus acetaminophen 1,000 mg orally. Efficacy was evaluated by standard analgesic
measures. Subjects treated as outpatients showed lower categorical pain intensity
for ketorolac tromethamine than hydrocodone and acetaminophen at 1 hour (P=.03), 2 hours (P=.006), and 3 hours (P=.02); lower summed intensity differences for ketorolac tromethamine than hydrocodone
and acetaminophen at 3 hours (P=.014) and 4 hours (P=.019); and better total pain relief for ketorolac tromethamine than hydrocodone and
acetaminophen at 3 hours (P=.014) and 4 hours (P=.013). With an effective loading dose administered before the subsequent oral dosage,
there was statistically better pain reduction with ketorolac tromethamine than with
hydrocodone and acetaminophen. Moreover, ketorolac tromethamine was no more likely
to cause digestive complaints than hydrocodone and acetaminophen. No bleeding problems
were observed in either group. In the outpatient setting, ketorolac tromethamine controls
postoperative pain better than hydrocodone and acetaminophen in the immediate postsurgery
period.
Arthroscopy 1998 Sep;14(6):605-12
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© 1998 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.