Study Objective: To determine the efficacy and speed of onset of analg
esia of a single dose of intravenous (IV) or intramuscular (IM) ketoro
lac tromethamine following major orthopedic surgery. Study Design: Dou
ble-blind, randomized, placebo-controlled trial. Setting: A district g
eneral hospital in England. Patients: 112 patients aged 18 to 80 years
suffering moderate or severe pain following orthopedic surgery. Inter
ventions: Patients were randomized to receive 30 mg ketorolac IV, 30 m
g ketorolac IM, or placebo following surgery. Measurements and Main Re
sults: Verbal pain intensity scores were performed prior to admission
to the study, then frequently for the first 45 minutes following admin
istration of study medication, and subsequently at hourly intervals. T
imes to request for further analgesia were noted. Patient assessment o
f overall acceptability and pain relief of the study medication was re
corded. There was no statistical difference in speed of onset of analg
esia between the ketorolac groups and placebo. Median (range) times to
first analgesic following study drugs were: ketorolac IV 45 minutes (
9 to 1440 minutes), ketorolac IM 34 minutes (10 to 1440 minutes), plac
ebo 24 minutes (10 to 615 minutes). There was a statistically signific
ant difference between the ketorolac groups and placebo (ketorolac IV
vs. placebo, p < 0.01; ketorolac IM vs. placebo, p = 0.03). Patient as
sessment of overall acceptability and pain relief was significantly be
tter for IV ketorolac compared with placebo (p < 0.01). By 6 hours, 78
% of the IV ketorolac group and 95% of the IM ketorolac and placebo gr
oups required further analgesia. Conclusions: Despite high patient acc
eptability compared with placebo, the use of ketorolac as the sole ana
lgesic failed to control postoperative pain following major orthopedic
surgery. IV administration of ketorolac conferred no advantages over
the IM route with regard to efficacy or speed of onset.