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

Autor: Jingyan Yang, Jeffrey Varghese, Todd J. Albert, Sheeraz A. Qureshi, Han Jo Kim, Dan Stein, Darren R. Lebl, Michael E. Steinhaus, Bernard A. Rawlins, Evangelia M. Zgonis, Frank J. Schwab, Federico P. Girardi, Harvinder S. Sandhu, James C. Farmer, Russel C. Huang, Sravisht Iyer, Matthew E. Cunningham, James D. Beckman
Rok vydání: 2019
Předmět:
Zdroj: The Spine Journal. 19:S148
ISSN: 1529-9430
DOI: 10.1016/j.spinee.2019.05.320
Popis: 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.
Databáze: OpenAIRE
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