Status:
TERMINATED
Paracervical Injection for Headache in the Emergency Department
Lead Sponsor:
Christian Fromm, MD
Conditions:
Headache Disorders, Primary
Pain Management
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
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-invasiv...
Detailed Description
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-invasiv...
Eligibility Criteria
Inclusion
- Age 18 to 64 years
- Suspected diagnosis of benign or primary headache
Exclusion
- 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
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04109885
Start Date
September 15 2020
End Date
January 30 2024
Last Update
August 1 2024
Active Locations (1)
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1
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141