Paracervical Injection for Headache in the Emergency Department

Stopped early · Phase 2

Conditions studied: Headache Disorders, Primary, Pain Management, Emergency Department

In brief

Headache is one of the most common presenting complaints in the emergency department.1 By the time patients with benign headaches present for treatment in the ED, they often have exhausted non-invasive treatments, and physicians are left with few therapeutic options. The investigators therefore propose to study the use of paracervical injection as a novel approach to managing headache in the emergency department. This procedure has great potential, if efficacious, to provide a safe, rapidly effective, non-sedating treatment for headache that does not involve intravenous line placement and systemic medication administration. To date, there are no published trials that evaluate this technique in this setting. The investigators intend to compare the efficacy of paracervical injection to standard first-line therapy (intravenous prochlorperazine and diphenhydramine) for the treatment of benign headache of any etiology in the emergency department.

Key facts

Study ID

NCT04109885

Run by

Christian Fromm, MD

People needed

19

Starts

2020-09-15

Expected to finish

2024-01-30

Last updated by the study team

2024-08-01

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 64 years
• Suspected diagnosis of benign or primary headache

You may not qualify if…

• Treating attending physician is suspicious of a serious secondary cause of headache
• History of brain disease, concussion, stroke, intracranial mass or tumor, hemorrhage, increased intracranial pressure, head trauma in last 2 weeks, status post intracranial surgery
• History of neck disease, cervical spine or disc abnormality, history of vertebral or carotid artery dissection, torticollis, status post cervical spine surgery or hardware in place
• Hypersensitivity or allergy to bupivacaine (amide anesthetics) or prochlorperazine (dopamine receptor antagonists)
• Overlying signs of infection at site of injection (erythema, purulence, open skin)
• History of extrapyramidal symptoms, dystonia, parkinsonism, tardive dyskinesia or neuroleptic malignant syndrome
• Pregnancy
• History of schizophrenia or bipolar disorder
• Narcotic seeking patients as determined by the treating attending physician with optional assistance from medical record and online database review
• Weight more than 150 kg or less than 40 kg
• Received pain medication in the ED or less than 6 hours prior to enrollment
• Temperature greater than 38 degrees Celcius
• Previous enrollment

Where it is running

• Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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