title: Noninvasive sphenopalatine ganglion block for acute headache in the emergency department: a randomized placebo-controlled trial.
abstract: OBJECTIVE
  We seek to test the efficacy of noninvasive sphenopalatine ganglion block for the treatment of acute anterior headache in the emergency department (ED) using a novel noninvasive delivery device.
  
  
  METHODS
  We conducted a randomized, double-blind, placebo-controlled trial evaluating bupivacaine anesthesia of the sphenopalatine ganglion for acute anterior or global-based headache. This study was completed in 2 large academic EDs. Bupivacaine or normal saline solution was delivered intranasally (0.3 mL per side) with the Tx360 device. Pain and nausea were measured at 0, 5, and 15 minutes by a 100-mm visual analog scale. The primary endpoint was a 50% reduction in pain at 15 minutes. Telephone follow-up assessed 24-hour pain and nausea through a 0- to 10-point verbal scale and adverse effects.
  
  
  RESULTS
  The median reported baseline pain in the bupivacaine group was 80 mm (IQR 66 mm - 93 mm) and 78.5 mm (IQR 64 mm to 91.75 mm) in the normal saline solution group. A 50% reduction in pain was achieved in 48.8% of the bupivacaine group (20/41 patients) versus 41.3% in the normal saline solution group (19/46 patients), for an absolute risk difference of 7.5% (95% confidence interval [CI] -13% to 27.1%). As a secondary outcome, at 24 hours, more patients in the bupivacaine group were headache free (24.7% difference; 95% CI 2.6% to 43.6%) and more were nausea free (16.9% difference; 95% CI 0.8% to 32.5%).
  
  
  CONCLUSIONS
  For patients with acute anterior headache, sphenopalatine ganglion block with the Tx360 device with bupivacaine did not result in a significant increase in the proportion of patients achieving a greater than or equal to 50% reduction in headache severity at 15 minutes compared with saline solution applied in the same manner.
authors.affiliation: Department of Emergency Medicine, Indiana University School of Medicine, Indianapolis, IN. Electronic address: jtschaff@iu.edu.
authors.forename: Jason T
authors.initials: JT
authors.lastname: Schaffer
authors.affiliation: Department of Emergency Medicine, Indiana University School of Medicine, Indianapolis, IN.
authors.forename: Benton R
authors.initials: BR
authors.lastname: Hunter
authors.affiliation: Indiana University School of Medicine, Indianapolis, IN.
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Ball
authors.affiliation: Department of Emergency Medicine, Indiana University School of Medicine, Indianapolis, IN.
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Weaver
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000779:Anesthetics, Local / Q000008:administration & dosage* / Q000627:therapeutic use; D002045:Bupivacaine / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006261:Headache / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D059387:Sphenopalatine Ganglion Block / Q000295:instrumentation*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000779:Anesthetics, Local; D002045:Bupivacaine