About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient has to be able to provide own consent
English-speaking only
Non traumatic headache with VAS pain score of 5 or above out of 10
Disqualifiers
traumatic headache
Confused patients
allergy to bupivacaine
infection over injection site
Trial design
Parallel
Treatments tested in this trial
0.5% Bupivacaine HCl
Drugbilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location for headache treatment
standard IV treatment for headache
Drugphysicians choice of IV medications in treatment of headache
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Emergency department length of stay
Duration that patients stayed in the Emergency department for
Need for additional medications
Whether an additional medication was given to patients after 30 minutes
Sponsors and contacts
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