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SPG Blocks for Headaches

Primary Purpose

Headache

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
SPG Block
Standard IV Treatment
Sponsored by
Kendall Healthcare Group, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache focused on measuring sphenopalatine ganglion block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kendall Regional Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SPG Block

Standard Treatment

Arm Description

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

Intravenous prochlorperazine 10 mg plus diphenhydramine 50 mg.

Outcomes

Primary Outcome Measures

Percentage of Patients with Substantial Pain Reduction at 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 Outcome Measures

Change in Mean Pain Score at 15 minutes
The difference in the mean 100 mm visual analog scale pain score from before treatment to 15 minutes after treatment, and the means for each group will be compared.
Change in Mean Pain Score at 30 minutes
The difference in the mean 100 mm visual analog scale pain score from before treatment to 15 minutes after treatment, and the means for each group will be compared.
Headache 24-72 hours later
Patients will be called by phone 24-72 hours after treatment in the ED to ask if they are having a headache (yes or no). The percentage of patients with a headache at that time will be compared between the groups.
Hospital Length of Stay
The mean length of time the patient remains in the hospital will be compared between groups.

Full Information

First Posted
February 3, 2020
Last Updated
September 2, 2020
Sponsor
Kendall Healthcare Group, Ltd.
Collaborators
Nova Southeastern University
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1. Study Identification

Unique Protocol Identification Number
NCT04255420
Brief Title
SPG Blocks for Headaches
Official Title
Sphenopalatine Ganglion Blocks for Headaches in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kendall Healthcare Group, Ltd.
Collaborators
Nova Southeastern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
sphenopalatine ganglion block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SPG Block
Arm Type
Experimental
Arm Description
Sphenopalatine ganglion block using cotton-tipped applicators soaked in 1% lidocaine will be performed.
Arm Title
Standard Treatment
Arm Type
Active Comparator
Arm Description
Intravenous prochlorperazine 10 mg plus diphenhydramine 50 mg.
Intervention Type
Procedure
Intervention Name(s)
SPG Block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard IV Treatment
Intervention Description
Intravenous prochlorperazine 10 mg plus diphenhydramine 50 mg will be administered.
Primary Outcome Measure Information:
Title
Percentage of Patients with Substantial Pain Reduction at 15 minutes
Description
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.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Change in Mean Pain Score at 15 minutes
Description
The difference in the mean 100 mm visual analog scale pain score from before treatment to 15 minutes after treatment, and the means for each group will be compared.
Time Frame
15 minutes
Title
Change in Mean Pain Score at 30 minutes
Description
The difference in the mean 100 mm visual analog scale pain score from before treatment to 15 minutes after treatment, and the means for each group will be compared.
Time Frame
30 minutes
Title
Headache 24-72 hours later
Description
Patients will be called by phone 24-72 hours after treatment in the ED to ask if they are having a headache (yes or no). The percentage of patients with a headache at that time will be compared between the groups.
Time Frame
24-72 hours
Title
Hospital Length of Stay
Description
The mean length of time the patient remains in the hospital will be compared between groups.
Time Frame
30 minutes to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 fever any acute abnormality on neurologic exam allergy to one of study drugs on oral anticoagulant already received analgesic treatment in the ED
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tony Zitek, MD
Phone
305-480-6602
Email
zitek10@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Zitek, MD
Organizational Affiliation
Kendall Healthcare Group, Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kendall Regional Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Zitek, MD
Phone
305-480-6602
Email
zitek10@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
After completion of data analysis, the data will be available indefinitely.
Citations:
PubMed Identifier
12890124
Citation
Yarnitsky D, Goor-Aryeh I, Bajwa ZH, Ransil BI, Cutrer FM, Sottile A, Burstein R. 2003 Wolff Award: Possible parasympathetic contributions to peripheral and central sensitization during migraine. Headache. 2003 Jul-Aug;43(7):704-14. doi: 10.1046/j.1526-4610.2003.03127.x.
Results Reference
result
PubMed Identifier
11279969
Citation
Maizels M, Geiger AM. Intranasal lidocaine for migraine: a randomized trial and open-label follow-up. Headache. 1999 Sep;39(8):543-51. doi: 10.1046/j.1526-4610.1999.3908543.x. Erratum In: Headache 1999 Nov-Dec;39(10):764.
Results Reference
result
PubMed Identifier
11282668
Citation
Blanda M, Rench T, Gerson LW, Weigand JV. Intranasal lidocaine for the treatment of migraine headache: a randomized, controlled trial. Acad Emerg Med. 2001 Apr;8(4):337-42. doi: 10.1111/j.1553-2712.2001.tb02111.x.
Results Reference
result
PubMed Identifier
25097606
Citation
Mohammadkarimi N, Jafari M, Mellat A, Kazemi E, Shirali A. Evaluation of efficacy of intra-nasal lidocaine for headache relief in patients refer to emergency department. J Res Med Sci. 2014 Apr;19(4):331-5.
Results Reference
result
PubMed Identifier
27889366
Citation
Avcu N, Dogan NO, Pekdemir M, Yaka E, Yilmaz S, Alyesil C, Akalin LE. Intranasal Lidocaine in Acute Treatment of Migraine: A Randomized Controlled Trial. Ann Emerg Med. 2017 Jun;69(6):743-751. doi: 10.1016/j.annemergmed.2016.09.031. Epub 2016 Nov 23.
Results Reference
result
PubMed Identifier
25577713
Citation
Schaffer JT, Hunter BR, Ball KM, Weaver CS. Noninvasive sphenopalatine ganglion block for acute headache in the emergency department: a randomized placebo-controlled trial. Ann Emerg Med. 2015 May;65(5):503-10. doi: 10.1016/j.annemergmed.2014.12.012. Epub 2015 Jan 7.
Results Reference
result
PubMed Identifier
8656545
Citation
Maizels M, Scott B, Cohen W, Chen W. Intranasal lidocaine for treatment of migraine: a randomized, double-blind, controlled trial. JAMA. 1996 Jul 24-31;276(4):319-21.
Results Reference
result

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SPG Blocks for Headaches

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