Paracervical Injection for Headache in the Emergency Department

NCT04109885 | Terminated Phase 2 FDA Drug

• 1 other identifier: 2019-173
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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-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

Outcome Measures

Primary Outcomes (1)

• Rate of symptom improvement

  Patient asked if symptoms are improved enough for patient to be discharged to home.

  30 minutes

Secondary Outcomes (3)

• Reduction in pain scale

  30 minutes

• Re-presentation for medical care

  72 hours

• Headache recurrence

  72 hours

Study Arms (2)

Paracervical injection

EXPERIMENTAL

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

Drug: Paracervical injection

Standard treatment

ACTIVE COMPARATOR

Intravenous administration of prochlorperazine and diphenhydramine.

Drug: prochlorperazine and diphenhydramine.(Standard Treatment)

Interventions

Paracervical injection DRUG

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

Paracervical injection

prochlorperazine and diphenhydramine.(Standard Treatment) DRUG

Intravenous administration of prochlorperazine and diphenhydramine.

Standard treatment

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Christian Fromm, MD: lead

Study Sites (1)

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Headache Disorders, Primary; Agnosia; Emergencies

Interventions

Prochlorperazine

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Christian Fromm, MD

  Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Clinical Trials

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 1, 2019
• Study Start: September 15, 2020
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)