A double-blind randomized controlled trial of continuous intravenous Ketorolac vs placebo for adjuvant pain control after renal surgery.
OBJECTIVE
To evaluate the efficacy and safety of a novel, continuous intravenous infusion of ketorolac, a powerful nonopioid analgesic, for postoperative pain control.


METHODS
A prospective, double-blind, randomized, placebo-controlled trial of a continuous infusion of ketorolac tromethamine in 1 L of normal saline vs placebo was performed in 135 patients aged 18 to 75 years after laparoscopic donor nephrectomy or percutaneous nephrolithotomy completed from October 7, 2008, through July 21, 2010. Primary study end points were the 24-hour differences in visual analog pain scores and total narcotic consumption, whereas secondary end points were differences in urine output, serum creatinine level, and hemoglobin level.


RESULTS
The study was stopped after randomization of 135 patients (68 in the ketorolac group and 67 in the placebo group) when interim analysis indicated that the difference in mean pain scores between the 2 groups (difference, 0.6) was smaller than the 1-point threshold set forth in the power calculations. No statistically significant change was noted in hemoglobin levels from preoperative to postoperative values (P=.13) or in postoperative serum creatinine levels (P=.13).


CONCLUSIONS
Although continuous infusion of ketorolac produced only a modest decrease in the use of narcotics, it appears to offer a safe therapeutic option for nonnarcotic pain control.


BACKGROUND
clinicaltrials.gov Identifiers: NCT00765128 and NCT00765232.
Department of Urology, Mayo Clinic Hospital, Phoenix, AZ 85054, USA.
Gwen M
GM
Grimsby
Sarah P
SP
Conley
Terrence L
TL
Trentman
Erik P
EP
Castle
Paul E
PE
Andrews
Laurie A
LA
Mihalik
Joseph G
JG
Hentz
Mitchell R
MR
Humphreys
D000328:Adult; D000368:Aged; D017024:Chemotherapy, Adjuvant; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006851:Hydrochloric Acid / Q000008:administration & dosage*; D007275:Injections, Intravenous; D020911:Ketorolac Tromethamine / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D011446:Prospective Studies; D012164:Retinal Diseases / Q000601:surgery; D016896:Treatment Outcome; D055815:Young Adult
D016861:Cyclooxygenase Inhibitors; D020911:Ketorolac Tromethamine; D006851:Hydrochloric Acid