Study Design.
Randomized, double-blinded, placebo-controlled trial
Objective.
Examine the effect of intravenous ketorolac (IV-K) on hospital opioid use compared to IV placebo (IV-P) and IV acetaminophen (IV-A).
Summary of Background Data.
Controlling postoperative pain while minimizing opioid use following lumbar spinal fusion is an important area of study.
Methods.
Patients aged 18-75 years undergoing 1-2 level lumbar fusion between April 2016 – December 2019 were included. Patients with chronic opioid use, smokers, and those on systemic glucocorticoids or contraindications to study medications were excluded. A block randomization scheme was used and study personnel, hospital staff, and subjects were blinded to assignment. Patients were randomized postoperatively. The IV-K group received 15mg (age > 65) or 30 mg (age <65) q6h for 48h, IV-A received 1000 mg q6h, and IV-P received normal saline q6h for 48h. Demographic and surgical details, opioid use in morphine milliequivalents (MME), opioid related adverse events (ORAE) and length of stay (LOS) were recorded. The primary outcome was in-hospital opioid use up to 72h.
Results.
171 patients were included (58 IV-K, 55 IV-A, 58 IV-P) in the intent-to-treat (ITT) analysis, with mean age 57.1 years. The IV-K group had lower opioid use at 72h (173±157 mg) versus IV-A (255±179 mg) and IV-P (299±179 mg) (P=0.000). In terms of opiate use, IV-K was superior to IV-A (P=0.025) and IV-P (P=0.000) on ITT analysis, although on per-protocol (PP) analysis the difference with IV-A did not reach significance (P=0.063). When compared to IV-P, IV-K patients reported significantly lower worst (P=0.004), best (P=0.001), average (P=0.001), and current pain (P=0.002) on POD1, and significantly shorter LOS (P=0.009) on ITT analysis. There were no differences in ORAEs, drain output, clinical outcomes, transfusion rates, or fusion rates.
Conclusions.
By reducing opioid use, improving pain control on POD1, and decreasing LOS without increases in complications or pseudarthrosis, IV-K may be an important component of ERAS protocols.