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Terminated Phase 2 Interventional

Paracervical Injection for Headache in the Emergency Department

ClinicalTrials.gov ID: NCT04109885

Public ClinicalTrials.gov record NCT04109885. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 6:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Intramuscular Paracervical Injection for Headache in the Emergency Department: A Randomized Controlled Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04109885
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Christian Fromm, MD
Other
Enrollment
19 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 64 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 14, 2020
Primary completion
Jan 29, 2024
Completion
Jan 29, 2024
Last update posted
Jul 31, 2024

2020 – 2024

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Albert Einstein Medical Center Philadelphia Pennsylvania 19141

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04109885, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 31, 2024 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04109885 live on ClinicalTrials.gov.

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