HeadachePhase 4NCT04255420
SPG Blocks for Headaches
A Phase 4 study testing SPG Block and Standard IV Treatment in people with Headache, run by Kendall Healthcare Group, Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache
- What is being tested?
- SPG Block and Standard IV Treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2020to 1 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient at least 18 years old who presented to the ED with a suspected primary headache.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kendall Regional Medical Center
Miami, Florida, 33175
Tony Zitek, MD, 305-480-6602, zitek10@gmail.com
About this study
Official title: Sphenopalatine Ganglion Blocks for Headaches in the Emergency Department
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.
Read the 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.
- Conditions
- Headache
- Being tested
- SPG Block, Standard IV Treatment
- Keywords
- sphenopalatine ganglion block
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPG BlockProcedure or surgery
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 TreatmentDrug
Intravenous prochlorperazine 10 mg plus diphenhydramine 50 mg will be administered.
| Study group | Role | What they receive |
|---|---|---|
| SPG Block | Experimental | Sphenopalatine ganglion block using cotton-tipped applicators soaked in 1% lidocaine will be performed. Receives: Procedure: SPG Block |
| Standard Treatment | Active comparator | Intravenous prochlorperazine 10 mg plus diphenhydramine 50 mg. Receives: Drug: Standard IV Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Secondary outcomes (4)
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.
Measured: 15 minutes
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.
Measured: 30 minutes
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.
Measured: 24-72 hours
Hospital Length of Stay
The mean length of time the patient remains in the hospital will be compared between groups.
Measured: 30 minutes to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start21 Feb 2020
- Primary completion30 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kendall Healthcare Group, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nova Southeastern University
- Responsible party
- Sponsor
- Investigators
- Tony Zitek, MD, Principal investigator, Kendall Healthcare Group, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255420
- Sponsor's protocol ID
- NSU IRB 2019-48
- Status last verified
- Sep 2020
- First submitted
- 3 Feb 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 12890124Maizels 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.
PubMed 11279969Blanda 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.
PubMed 11282668Mohammadkarimi 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.
PubMed 25097606Avcu 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.
PubMed 27889366Schaffer 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.
PubMed 25577713Maizels 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.
PubMed 8656545
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphenopalatine Ganglion Blocks for Headaches in the Emergency Department
- ClinicalTrials.gov ID
- NCT04255420
- Acronym / sponsor ID
- NSU IRB 2019-48
- Conditions
- Headache
- Keywords
- sphenopalatine ganglion block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Kendall Healthcare Group, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nova Southeastern University
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPG Block | Experimental | Procedure: SPG BlockSphenopalatine ganglion block using cotton-tipped applicators soaked in 1% lidocaine will be performed. |
| Standard Treatment | Active comparator | Drug: Standard IV TreatmentIntravenous prochlorperazine 10 mg plus diphenhydramine 50 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient at least 18 years old who presented to the ED with a suspected primary headache.
Key exclusion criteria (8 listed)
- pregnant women
- prisoners
- meningeal signs
- fever
- any acute abnormality on neurologic exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPG BlockA 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. | Procedure or surgery | SPG Block |
| Standard IV TreatmentIntravenous prochlorperazine 10 mg plus diphenhydramine 50 mg will be administered. | Drug | Standard Treatment |
Primary outcome
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.
4 secondary outcomes
Change in Mean Pain Score at 15 minutes
Time frame: 15 minutes
Change in Mean Pain Score at 30 minutes
Time frame: 30 minutes
Headache 24-72 hours later
Time frame: 24-72 hours
Hospital Length of Stay
Time frame: 30 minutes to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Results publication: PubMed 12890124Yarnitsky 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 publication: PubMed 11279969Maizels 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.
- Results publication: PubMed 11282668Blanda 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 publication: PubMed 25097606Mohammadkarimi 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 publication: PubMed 27889366Avcu 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 publication: PubMed 25577713Schaffer 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 publication: PubMed 8656545Maizels 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Zitek, MD principal investigator
Kendall Healthcare Group, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SPG Block and Standard IV Treatment in people with Headache, run by Kendall Healthcare Group, Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tony Zitek, MD (305-480-6602, zitek10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients with Substantial Pain Reduction at 15 minutes (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04255420, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020; AzTrials last refreshed its copy on 27 Oct 2026.