drugset / Trial / NCT04109885

Paracervical Injection for Headache in the Emergency Department

NCT04109885

Phase 2 Terminated 19 enrolled Christian Fromm, MD
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-09-15
Primary completion
2024-01-30
Completion
2024-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.5 % Intramuscular
Subject Bupivacaine Other / unclassified 1.5 ml Intramuscular
Comparator Diphenhydramine Unknown Intravenous
Comparator Prochlorperazine Small molecule Intravenous

Indications