SPG Blocks for Headaches
- Conditions
- Headache
- Interventions
- Drug: Standard IV TreatmentProcedure: SPG Block
- Registration Number
- NCT04255420
- Lead Sponsor
- Kendall Healthcare Group, Ltd.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 84
- Any patient at least 18 years old who presented to the ED with a suspected primary headache.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Treatment Standard IV Treatment Intravenous prochlorperazine 10 mg plus diphenhydramine 50 mg. SPG Block SPG Block Sphenopalatine ganglion block using cotton-tipped applicators soaked in 1% lidocaine will be performed.
- Primary Outcome Measures
Name Time Method Percentage of Patients with Substantial Pain Reduction at 15 minutes 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
Name Time Method Change in Mean Pain Score at 30 minutes 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.
Change in Mean Pain Score at 15 minutes 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.
Hospital Length of Stay 30 minutes to 1 week The mean length of time the patient remains in the hospital will be compared between groups.
Headache 24-72 hours later 24-72 hours 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.
Trial Locations
- Locations (1)
Kendall Regional Medical Center
🇺🇸Miami, Florida, United States