Recruiting

SPG Blocks

Sponsor:

Kendall Healthcare Group, Ltd.

Code:

NCT04255420

Conditions

Headache

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SPG Block

Standard IV Treatment

Study Details

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.

Conditions

Headache

Study ID

NCT04255420

Start date

Feb 21, 2020

Status verified date

Sep, 2020

Completion date

Jun 1, 2021

Anticipated

Primary completion date

May 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • fever
  • any acute abnormality on neurologic exam
  • allergy to one of study drugs
  • on oral anticoagulant
  • already received analgesic treatment in the ED

Study Design

Enrollment

84 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SPG Block

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

active comparator: Standard Treatment

Intravenous prochlorperazine 10 mg plus diphenhydramine 50 mg.

Interventions

SPG Block

A cotton-tipped applicator soaked in 1% lidocaine will be inserted into the nostril on the side of the headache. If the headache is bilateral, two cotton-tipped applicators will be inserted. The cotton-tipped applicators will be left in place for 15 minutes.

Standard IV Treatment

Intravenous prochlorperazine 10 mg plus diphenhydramine 50 mg will be administered.

Primary outcome measure

  • Percentage of Patients with Substantial Pain Reduction at 15 minutes [ Time Frame: 15 minutes ]

Central Contacts and Locations

Central contacts

Tony Zitek, MD

305-480-6602zitek10@gmail.com

Locations

Kendall Regional Medical Center

Recruiting

Miami, Florida, United States, 33175

Contacts

Tony Zitek, MD

305-480-6602zitek10@gmail.com

More Information

Sponsor

Kendall Healthcare Group, Ltd.

Last update posted

Sep 3, 2020

Last verified

Sep, 2020

Keywords

  • sphenopalatine ganglion block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kendall Healthcare Group, Ltd. on 2020-09-03.