TY - JOUR
T1 - A double-blind randomized controlled trial of continuous intravenous ketorolac vs placebo for adjuvant pain control after renal surgery
AU - Grimsby, Gwen M.
AU - Conley, Sarah P.
AU - Trentman, Terrence L.
AU - Castle, Erik P.
AU - Andrews, Paul E.
AU - Mihalik, Laurie A.
AU - Hentz, Joseph G.
AU - Humphreys, Mitchell R.
N1 - Funding Information:
Grant Support: This project was funded by a CR5 Mayo Clinic grant.
Funding Information:
Potential Competing Interests: Dr Castle is a speaker for Intuitive Surgical Inc. Dr Humphreys has a consulting agreement with Boston Scientific Corp, Lumenis Inc, and Medafor Inc. Mr Hentz has received grant support for research activity from Allergan Inc , Anodyne Therapy LLC , Astellas Pharma US Inc , Dynatherm Medical Inc , Genentech Inc , InKline Pharmaceuticals Inc , Medtronic Inc , and Millennium Pharmaceuticals Inc .
PY - 2012/11
Y1 - 2012/11
N2 - Objective: To evaluate the efficacy and safety of a novel, continuous intravenous infusion of ketorolac, a powerful nonopioid analgesic, for postoperative pain control. Patients and 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). Conclusion: 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.
AB - Objective: To evaluate the efficacy and safety of a novel, continuous intravenous infusion of ketorolac, a powerful nonopioid analgesic, for postoperative pain control. Patients and 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). Conclusion: 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.
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U2 - 10.1016/j.mayocp.2012.07.018
DO - 10.1016/j.mayocp.2012.07.018
M3 - Article
C2 - 23058854
AN - SCOPUS:84872236594
SN - 0025-6196
VL - 87
SP - 1089
EP - 1097
JO - Mayo Clinic proceedings
JF - Mayo Clinic proceedings
IS - 11
ER -