Noninvasive Sphenopalatine Ganglion Block for Acute Headache in the Emergency Department: A Randomized Placebo-Controlled Trial

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

Study 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%). Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)503-510
Number of pages8
JournalAnnals of Emergency Medicine
Volume65
Issue number5
DOIs
StatePublished - May 1 2015
Externally publishedYes

Fingerprint

Sphenopalatine Ganglion Block
Bupivacaine
Headache
Hospital Emergency Service
Randomized Controlled Trials
Placebos
Sodium Chloride
Pain
Nausea
Confidence Intervals
Equipment and Supplies
Visual Analog Scale
Telephone
Ganglia
Anesthesia

ASJC Scopus subject areas

  • Emergency Medicine
  • Medicine(all)

Cite this

@article{ef5709757e88411689f4f546b3a72c44,
title = "Noninvasive Sphenopalatine Ganglion Block for Acute Headache in the Emergency Department: A Randomized Placebo-Controlled Trial",
abstract = "Study 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{\%}). Conclusion: 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.",
author = "Jason Schaffer and Benton Hunter and Ball, {Kevin M.} and Christopher Weaver",
year = "2015",
month = "5",
day = "1",
doi = "10.1016/j.annemergmed.2014.12.012",
language = "English (US)",
volume = "65",
pages = "503--510",
journal = "Annals of Emergency Medicine",
issn = "0196-0644",
publisher = "Mosby Inc.",
number = "5",

}

TY - JOUR

T1 - Noninvasive Sphenopalatine Ganglion Block for Acute Headache in the Emergency Department

T2 - A Randomized Placebo-Controlled Trial

AU - Schaffer, Jason

AU - Hunter, Benton

AU - Ball, Kevin M.

AU - Weaver, Christopher

PY - 2015/5/1

Y1 - 2015/5/1

N2 - Study 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%). Conclusion: 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.

AB - Study 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%). Conclusion: 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.

UR - http://www.scopus.com/inward/record.url?scp=84929032546&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84929032546&partnerID=8YFLogxK

U2 - 10.1016/j.annemergmed.2014.12.012

DO - 10.1016/j.annemergmed.2014.12.012

M3 - Article

C2 - 25577713

AN - SCOPUS:84929032546

VL - 65

SP - 503

EP - 510

JO - Annals of Emergency Medicine

JF - Annals of Emergency Medicine

SN - 0196-0644

IS - 5

ER -