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Paracervical Injection for Headache Management

Phase 2

Waitlist Available

Research Sponsored by Christian Fromm, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 to 64 years

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

Study Summary

This trial will study the use of paracervical injection as a novel approach to managing headache in the emergency department, compared to standard first-line therapy.

Who is the study for?

This trial is for adults aged 18 to 64 with suspected benign headaches, who haven't taken pain medication in the ED or within the last 6 hours. It's not for those over 150 kg or under 40 kg, pregnant, have certain neurological conditions, history of severe mental illness, drug-seeking behavior as assessed by a physician, or allergies to specific anesthetics and antipsychotics.Check my eligibility

What is being tested?

The study is testing paracervical injections as a new headache treatment in the emergency department against standard therapy (IV prochlorperazine and diphenhydramine). The goal is to see if this method can quickly relieve headaches without sedation or systemic drugs.See study design

What are the potential side effects?

Possible side effects may include reactions at the injection site like redness or infection signs. Systemic medications could cause drowsiness, dry mouth, restlessness and rarely extrapyramidal symptoms like abnormal muscle movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 64 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of symptom improvement

Secondary outcome measures

Headache recurrence

Re-presentation for medical care

Reduction in pain scale

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Paracervical injectionExperimental Treatment1 Intervention

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

Group II: Standard treatmentActive Control1 Intervention

Intravenous administration of prochlorperazine and diphenhydramine.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Christian Fromm, MDLead Sponsor

Media Library

Paracervical Injection (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04109885 — Phase 2

Emergency Department Clinical Trial 2023: Paracervical Injection Highlights & Side Effects. Trial Name: NCT04109885 — Phase 2

Paracervical Injection (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04109885 — Phase 2

Emergency Department Research Study Groups: Paracervical injection, Standard treatment

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical trial open to all patient demographics?

"Successful applicants to the trial must have hypnic headache and fall into an age bracket between 18 and 64. In total, 108 volunteers are needed for this medical study."

Answered by AI

What afflictions are commonly remedied by utilizing paracervical injection?

"Paracervical injection is a viable treatment option for conditions such as angioedema, bronchitis, and delayed hypersensitivity."

Answered by AI

Are recruitment efforts ongoing for this trial?

"This research endeavour is still seeking participants, as indicated by clinicaltrials.gov's records. It was first listed on September 15th 2020 and the information was most recently changed on December 1st 2021."

Answered by AI

What potential risks and side effects are associated with Paracervical injection?

"The safety of Paracervical injection was rated a 2 because, despite some evidence being present on its security profile, none exists in regards to efficacy."

Answered by AI

Could you elucidate the number of medical experiments that have employed Paracervical injection?

"Currently, 34 experimental treatments for Paracervical injection are being conducted. 10 of those live experiments have reached Phase 3 and are based primarily in Saint Petersburg, Florida with 825 other locations hosting their own trials."

Answered by AI

Is geriatric eligibility a criterion for enrollment in this experiment?

"This medical trial is only open to participants aged between 18 and 64. However, there are 68 studies which accept minors as participants and 295 trials for people beyond the age of 65."

Answered by AI

What is the participant quota for this medical research?

"Affirmative. Clinicaltrials.gov confirms that the trial, which was initially featured on September 15th 2020, is actively recruiting individuals for participation. 108 patients need to be enrolled from 1 centre of medical care."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Paracervical Injection for Headache in the Emergency Department

Christian Fromm, MD 2020. "Paracervical Injection for Headache in the Emergency Department". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04109885.

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