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Headache is a frequent chief complaint among patients presenting to the Emergency Department (ED), accounting for 2.1 million visits annually in the United States. Often, individuals resort to ED care only after over-the-counter or home remedies have failed, leading to the predominant use of intravenous (IV) medications in the ED, including NSAIDs, triptans, neuroleptics, antiepileptics, and dopaminergic antagonists. Unfortunately, these pharmacologic treatments frequently induce side effects such as cognitive impairment, extrapyramidal reactions, and the potential for medication dependency. In the ED, patients frequently require concurrent administration of multiple systemic medications to achieve satisfactory pain relief, thereby elevating the risk associated with medication use. Despite these medication regimens, a significant portion of patients continue to experience inadequate pain relief. Consequently, the search for an optimal headache therapy-characterized by rapid and effective pain relief, long lasting results, minimal side effects, and allows for rapid ED patient turnover-continues to be a popular area of research in emergency medicine. The investigators plan to evaluate the use of 0.5% bupivacaine cervical IM injection at the c6-7 location for the treatment of non traumatic headaches using a non-inferiority design, randomized, prospective, open-label, controlled trial comparing it to physicians choice of intravenous medications in treatment of headache in the Emergency Department at North Florida Hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous medication | Active Comparator | physicians choice of intravenous medication for headache treatment |
|
| cervical IM injection | Experimental | bilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5% Bupivacaine HCl | Drug | bilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location for headache treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale pain score 0-10 | Pain score at 30 minutes and 24 hours after treatment. 0 being no pain and 10 being the worse pain possible. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency department length of stay | Duration that patients stayed in the Emergency department for | 24 hours |
| Need for additional medications | Whether an additional medication was given to patients after 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhengqiu zhou, MD | Contact | 8593686486 | zhengqiu.zhou@icloud.com |
| Name | Affiliation | Role |
|---|---|---|
| Robyn Hoelle, MD | HCA north florida hospital emergency department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCA Florida north florida Hospital | Gainesville | Florida | 32605 | United States |
individual participant data will not be shared to protect patient safety and their healthcare information.
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|
| standard IV treatment for headache | Drug | physicians choice of IV medications in treatment of headache |
|
| 24 hours |
| ID | Term |
|---|---|
| D006261 | Headache |
| D008881 | Migraine Disorders |
| D018781 | Tension-Type Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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