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Paracervical Injection for Headache in the Emergency Department

NCT04109885 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-08-01

No results posted yet for this study

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-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.

Conditions

  • Headache Disorders, Primary
  • Pain Management
  • Emergency Department

Interventions

DRUG

Paracervical injection

1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine.

DRUG

prochlorperazine and diphenhydramine.(Standard Treatment)

Intravenous administration of prochlorperazine and diphenhydramine.

Sponsors & Collaborators

  • Christian Fromm, MD

    lead OTHER

Principal Investigators

  • Christian Fromm, MD · Einstein Healthcare Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2024-01-30
Completion
2024-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04109885 on ClinicalTrials.gov