303. 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 amongst the most painful surgical procedures. Adequately controlling post-operative pain while minimizing opioid use is an important public health objective PURPOSE The purpose of this study was to examine the effect of intravenous ketorolac (IV-K) on hospital opioid use compared to IV placebo (IV-P) and IV Acetaminophen (IV-A). STUDY DESIGN/SETTING Prospective, randomized, double-blind trial. PATIENT SAMPLE Patients aged 18-75 undergoing 1-2 level posterior lumbar fusion without history of long-term opioid use. Smokers and those with contraindications to IV-A or IV-K were excluded OUTCOME MEASURES The primary outcome was in-hospital opioid use up to post-operative day 3 (POD3). The secondary outcomes were opioid related adverse events (ORAE) and length of stay (LOS). METHODS Patients (Pts) were randomized to receive IV-K, IV-P or IV-A. IV-K pts received 15mg (age > 65) or 30mg (age RESULTS A total of 115 patients met the inclusion criteria (39 IV-K, 39 IV-A, 37 IV-P). There was no difference between patients with regards to demographic or surgical variables. The 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/hr; IV-A: 4.1±2.3mg/hr; IV-P: 4.7±2.5mg/hr, 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±44hr; IV-A: 93±60hr; IV-P:88±35hr, p=0.231). There were no differences in ORAE, drain output, hematocrit levels, serum creatinine and transfusion rates. CONCLUSIONS 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 is planned to assess the impact of IV-K on pseudarthrosis. FDA DEVICE/DRUG STATUS Unavailable from authors at time of publication.