2017 Research Grant: Intravenous ketorolac substantially reduces opioid use following lumbar spinal fusion: early results of a randomized, double-blinded, placebo controlled trial

Abstract

BACKGROUND CONTEXT Lumbar spine fusions are rated among the most painful surgical procedures. Adequately controlling postoperative pain while minimizing opioid use is an important public health objective. SUMMARY Early results of this double-blind, randomized, placebo-controlled trial show that intravenous ketorolac (IV-K) results in a substantial reduction in opioid use and improved pain control compared to placebo (IV-P) and IV acetaminophen (IV-A). IV-K did not increase rates of hematoma, drain output, transfusions or serum creatinine. There was a trend toward decreased length of stay (LOS) with IV-K. HYPOTHESIS IV-K would decrease in hospital opioid use compared to IV Placebo (IV-P) and Intravenous Acetaminophen (IV-A). DESIGN Randomized, double-blind trial. METHODS Patients (Pts) were randomized to receive IV-K, IV-P or IV-A. The inclusion criteria were: age 18-75, 1-2 level lumbar fusion and no history of long-term opioid use. Smokers and pts with contraindications to IV-A or IV-K were excluded. IV-K pts received 15mg (age >65) or 30mg (age RESULTS A total of 115 pts met inclusion criteria (39 IV-K, 39 IV-A, 37 IV-P). There was no difference between pts with regard to demographic or surgical variables. IV-K group had substantially lower opioid use at 72h (181±156mg) compared to IV-A (268±176mg) and IV-P (315±183mg) (p=0.003). IV-K was superior to IV-A (p=0.030) and IV-P (0.001). IV-A was not superior to IV-P (p=0.234). Similar trends were observed for opioid use per-hour (IV-K: 3.0±2.4mg/h; IV-A: 4.1±2.3mg/h; IV-P: 4.7±2.5mg/h, p=0.009). IV-K pts reported improved pain control on POD1 (p=0.050). IV-K pts trended toward shorter LOS (IV-K: 75±44h; IV-A: 93±60h; IV-P:88±35h, p=0.231). There were no differences in ORAE, drain output, hematocrit levels, serum creatinine and transfusion rates. CONCLUSION IV-K results in a substantial reduction in opioid use (>40% vs IV-P, >30% vs IV-A) and improved pain control on POD1. There is a trend toward decreased LOS; there appears to be no increase in in-hospital complications. Longer term follow-up will assess impact of IV-K on pseudarthrosis. IV-K reduces opioid use after spinal fusion by >40% compared to placebo and >30% compared to IV acetaminophen. There is a trend toward decreased LOS with IV-K. FDA DEVICE/DRUG STATUS Intravenous ketorolac and intravenous acetaminophen are FDA app