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Clinical Trials/NCT04255420
NCT04255420
Unknown
Phase 4

Sphenopalatine Ganglion Blocks for Headaches in the Emergency Department

Kendall Healthcare Group, Ltd.1 site in 1 country84 target enrollmentFebruary 21, 2020

Overview

Phase
Phase 4
Intervention
SPG Block
Conditions
Headache
Sponsor
Kendall Healthcare Group, Ltd.
Enrollment
84
Locations
1
Primary Endpoint
Percentage of Patients with Substantial Pain Reduction at 15 minutes
Last Updated
5 years ago

Overview

Brief Summary

This will be a single-center, open-label clinical trial comparing sphenopalatine ganglion blocks to standard intravenous therapy for patients who come to the emergency department for a headache.

Detailed Description

Having outperformed other agents in head-to-head trials, intravenous (IV) dopamine antagonists, such as prochlorperazine or metoclopramide, are generally considered the 1st line treatment for headaches in the ED. However, despite the relative effectiveness of prochlorperazine, a substantial number of patients who present to the ED with a headache still have a moderate to severe headache 24 hours after discharge. Moreover, some patients may have difficult IV access, so it would be useful to employ a technique that could effectively treat headaches without the use of an IV line. One therapy that has been suggested but not well-studied that might help treat headaches in the ED without the use of an IV line is the sphenopalatine ganglion (SPG) block via intranasal lidocaine. The sphenopalatine ganglion may play a role in the development of pain in primary headaches through the release of neuropeptides that activate or sensitize intracranial nociceptors. Several prior randomized trials have evaluated the use of intranasal lidocaine or bupivacaine vs placebo for patients with migraine headaches, and the results have been mixed. Thus, the investigators propose a single-center, open-label, clinical trial to compare the efficacy of SPG blocks to standard IV therapy for headaches in the ED. Adult patients who come to the ED for a suspected primary headache may be enrolled. Patients who are assigned to the standard IV therapy group will receive prochlorperazine 10 mg and diphenhydramine 50 mg. Patients who are assigned to the SPG block group will undergo the following procedure. A cotton-tipped applicator soaked in 1% lidocaine will be placed in the nostril on the side of the headache. If the headache is bilateral, a cotton-tipped applicator will be inserted into each nostril. The cotton-tipped applicator(s) will be left in place for 15 minutes. If the patient has not had significant improvement upon removal of the cotton-tipped applicator the physician may order IV medication for the patient's headache ("rescue analgesia"). Just before the initiation of treatment, an initial visual analog scale (VAS) pain score will be obtained from the patient. The VAS pain score will be repeated 15 and 30 minutes after treatment. Additional data will be determined through chart review and telephone follow up with the patient 24-72 hours after discharge. The primary outcome of the study will be the difference between groups in the fraction of patients with a 50% reduction in VAS pain score at 15 minutes. Secondarily, the investigators will compare groups with regards to their mean VAS pain scores as 15 and 30 minutes after the initiation of the first treatment, hospital length of stay, the need for rescue analgesic medications, complications (nose bleed, akathisia, etc.), and presence of persistent headache 24-72 hours after discharge on telephone follow up.

Registry
clinicaltrials.gov
Start Date
February 21, 2020
End Date
June 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Any patient at least 18 years old who presented to the ED with a suspected primary headache.

Exclusion Criteria

  • pregnant women
  • prisoners
  • meningeal signs
  • any acute abnormality on neurologic exam
  • allergy to one of study drugs
  • on oral anticoagulant
  • already received analgesic treatment in the ED

Arms & Interventions

SPG Block

Sphenopalatine ganglion block using cotton-tipped applicators soaked in 1% lidocaine will be performed.

Intervention: SPG Block

Standard Treatment

Intravenous prochlorperazine 10 mg plus diphenhydramine 50 mg.

Intervention: Standard IV Treatment

Outcomes

Primary Outcomes

Percentage of Patients with Substantial Pain Reduction at 15 minutes

Time Frame: 15 minutes

The percentage of patients whose 100 mm visual analog scale pain score reduced by at least 50% from before treatment until 15 minutes after the start of treatment.

Secondary Outcomes

  • Change in Mean Pain Score at 30 minutes(30 minutes)
  • Change in Mean Pain Score at 15 minutes(15 minutes)
  • Headache 24-72 hours later(24-72 hours)
  • Hospital Length of Stay(30 minutes to 1 week)

Study Sites (1)

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