title: Double-blind, randomized, double-dummy clinical trial comparing the efficacy of ketorolac trometamol and naproxen for acute low back pain.
abstract: BACKGROUND
  Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most common type of medication used in the treatment of acute pain. Ketorolac trometamol (KT) is a nonnarcotic, peripherally acting nonsteroidal anti-inflammatory drug with analgesic effects comparable to certain opioids.
  
  
  OBJECTIVE
  The aim of this study was to compare the efficacy of KT and naproxen (NA) in the treatment of acute low back pain (LBP) of moderate-to-severe intensity.
  
  
  METHODS
  In this 10-day, Phase III, randomized, double-blind, double-dummy, noninferiority trial, participants with acute LBP of moderate-to-severe intensity as determined through a visual analog scale (VAS) were randomly assigned in a 1:1 ratio to receive sublingual KT 10 mg three times daily or oral NA 250 mg three times daily. From the second to the fifth day of treatment, if patient had VAS >40 mm, increased dosage to four times per day was allowed. The primary end point was the reduction in LBP as measured by VAS. We also performed a post hoc superiority analysis.
  
  
  RESULTS
  KT was not inferior to NA for the reduction in LBP over 5 days of use as measured by VAS scores (P=0.608 for equality of variance; P=0.321 for equality of means) and by the Roland-Morris Disability Questionnaire (P=0.180 for equality of variance test; P=0.446 for equality of means) using 95% confidence intervals. The percentage of participants with improved pain relief 60 minutes after receiving the first dose was higher in the KT group (24.2%) than in the NA group (6.5%; P=0.049). The most common adverse effects were heartburn, nausea, and vomiting.
  
  
  CONCLUSIONS
  KT is not inferior in efficacy and delivers faster pain relief than NA.
authors.affiliation: Orthopedic and Traumatology Institute of Clinical Hospital, University of São Paulo, Brazil.
authors.forename: Pérola Grinberg
authors.initials: PG
authors.lastname: Plapler
authors.affiliation: Clinical Research Center Hospital AACD, São Paulo, Brazil.
authors.forename: Morton Aaron
authors.initials: MA
authors.lastname: Scheinberg
authors.affiliation: NC Group Medical Affairs, Hortolândia, São Paulo, Brazil.
authors.forename: Christina da Cunha
authors.initials: Cda C
authors.lastname: Ecclissato
authors.affiliation: NC Group Medical Affairs, Hortolândia, São Paulo, Brazil.
authors.forename: Monalisa Fernanda
authors.initials: MF
authors.lastname: Bocchi de Oliveira
authors.affiliation: NC Group Medical Affairs, Hortolândia, São Paulo, Brazil.
authors.forename: Roberto Bleuel
authors.initials: RB
authors.lastname: Amazonas
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000737:chemistry / Q000378:metabolism; D004311:Double-Blind Method; D006801:Humans; D020910:Ketorolac / Q000008:administration & dosage* / Q000737:chemistry / Q000378:metabolism; D017116:Low Back Pain / Q000188:drug therapy*; D009288:Naproxen / Q000008:administration & dosage* / Q000737:chemistry / Q000378:metabolism; D014325:Tromethamine / Q000008:administration & dosage* / Q000737:chemistry / Q000378:metabolism
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D014325:Tromethamine; D009288:Naproxen; D020910:Ketorolac
keywords: acute low back pain; ketorolac trometamol; naproxen; nonsteroidal anti-inflammatory drugs