Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04109885 |
Other study ID # |
2019-173 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
September 15, 2020 |
Est. completion date |
September 15, 2024 |
Study information
Verified date |
May 2023 |
Source |
Albert Einstein Healthcare Network |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
Amongst the array of medications used by physicians to manage benign headache, dopamine
antagonists have demonstrated the best efficacy in trials. A number of studies have
demonstrated the efficacy of dopamine antagonists in treating migraine, tension,
cluster-type, and other benign headaches2,3 Dopamine antagonists have shown superiority over
opioids4, non-steroidal anti-inflammatory drugs5, triptans6, and anti-epileptics7.
Prochlorperazine is probably the most studied and most commonly clinically utilized in this
regard in the ED setting.
Despite the preponderance of evidence supporting the use of dopamine antagonists as
first-line therapeutic agents in the ED management of benign headache, more than half of the
1.2 million patients treated in U.S. emergency departments for acute migraine are treated
with opioids despite the known risks and recommendations to the contrary.12 In addition,
there is tremendous variation in the medications chosen by ED physicians for managing benign
headache.13 Most of these regimens involve administration of systemic medications that have
considerable side effect profiles. Moreover, many of these headache cocktails require
prolonged durations of treatment with sedative side effects. This results in prolonged ED
lengths of stay that occupy valuable bed space in increasingly busy and crowded emergency
departments.
A less well-known approach to managing benign headache is bilateral, paracervical,
intramuscular injection of a long-acting anesthetic. The mechanism of action is not entirely
understood, however it is postulated to involve neuronal pathways in the trigeminocervical
complex thought to play a central role in headache physiology. This is similar in concept to
the mechanism proposed for the occipital nerve blocks performed by neurologists.
Paracervical injection was first described by Mellick et al.8 This method has the advantage
of ease of administration, favorable safety profile, lack of need for intravenous access,
lack of sedative side effects, and swiftness of therapeutic response. In Mellick's case
series, he treated 417 patients who presented with all manner of benign headaches with a 65%
rate of complete relief of pain and a 20% rate of partial relief. Many patients had rapid
relief of headache within 5 minutes and the remainder in less than 30 minutes. This study was
limited by possible selection bias, given it is unclear why the specific patients enrolled
were chosen for this treatment. The study was also limited by its observational nature and
lack of a control group.
In recent years this procedure has gained popularity amongst emergency physicians, and it has
been widely discussed in emergency medicine blogs and podcasts. Numerous online videos
demonstrate the ease with which the procedure is performed by physicians and tolerated by
patients. Many physicians have called for clinical trials to assess its efficacy.
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.