Headache, MigrainePhase 4NCT02972502
Efficacy of Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department
A Phase 4 study testing Metoclopramide, Haloperidol and Normal Saline in people with Headache, Migraine, run by OhioHealth at 1 site in United States.
Trial summary
Metoclopramide (Reglan) is a common agent used for relief of headaches in the emergency department (ED).In this study the investigators seek to explore another option for treatment of headaches in the ED, one that may be more efficacious and efficient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- Metoclopramide, Haloperidol and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 24 Apr 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who present with a headache or migraine with onset less than or equal to 72 hours
Who cannot join
- Known pregnancy
- Breast-feeding women
- Known history of arrhythmias or QT prolongation (450 ms)
- Known adverse effects to haloperidol, diphenhydramine (Benadryl) or metoclopramide
- Subarachnoid hemorrhage
- Headaches caused by trauma, meningitis
Show all 13Show fewer
- Congestive heart failure
- Parkinson's Disease
- Dementia
- Pheochromocytoma
- History of glaucoma
- History of seizures
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Efficacy of Using Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department: A Prospective Randomized Clinical Trial
Metoclopramide (Reglan) is a common agent used for relief of headaches in the emergency department (ED).In this study the investigators seek to explore another option for treatment of headaches in the ED, one that may be more efficacious and efficient. Haloperidol (Haldol), a butyrophenone class of medication, is thought to act by affecting the dopamine 2 receptor in the brain.
By exploring haloperidol as an option for treatment, the investigators hope to discover a more efficient and effective medication for the treatment of non-traumatic headaches, thereby decreasing a patient's length of stay in the department and decreasing the rate of return visits for continued discomfort from the same headache. This study could lead to the increased usage of haloperidol as a first line agent in the treatment of prolonged headaches presenting to the ED.
Read the detailed description
At this time, choice of medications for the treatment of headaches in the ED is still based on personal and patient preferences because no properly constructed trials have been carried out that would allow identification of a superior agent. Metoclopramide (Reglan) is a common agent used for relief of headaches in the ED. Uncontrolled studies have shown successful relief of migraine with metoclopramide of 75%. Further studies have reported success rate of 67% with IV metoclopramide. In this study the investigators seek to explore another option for treatment of headaches in the ED, one that may be more efficacious and efficient. Haloperidol (Haldol), a butyrophenone class of medication, is thought to act by affecting the dopamine 2 receptor in the brain. These receptors are relatively abundant in the brainstem nuclei and sympathetic ganglia and nerves, through which they may regulate autonomic visceral, gastrointestinal, and hemodynamic responses frequently associated with migraine. One study, demonstrated that 4 out of 5 patients felt significant relief in pain intensity with the use of haloperidol, even when other medications had failed. Relapses were rare, and several patients reported that haloperidol interrupted the prolonged, intractable migraine spiral they had suffered for days. Furthermore, a case series of six cases of migraine treated with 5mg of haloperidol IV after a 500 to 1000ml bolus of IV fluids reported complete or substantial relief within 25 to 65 minutes and side effects were reported as minimal.
The investigators hypothesize that Haloperidol is more efficacious than metoclopramide in the treatment of an acute headache or migraine in the ED in regard to a self-reported pain rating scale (Numeric Pain Intensity Scale), need for additional medication, emergency department return rates, and resolution of symptoms.
- Conditions
- Headache, Migraine
- Being tested
- Metoclopramide, Haloperidol, Normal Saline, Diphenhydramine
- Keywords
- Metoclopramide (Reglan), Haloperidol (Haldol)
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoclopramideDrug
Also called Reglan
Patients receive 10 mg of intravenous (IV) metoclopramide.
HaloperidolDrug
Also called Haldol
Patients receive 2.5 mg of IV haloperidol.
Normal SalineOther
All patients receive a 1-liter bolus of normal saline (NS)
DiphenhydramineDrug
Also called Benadryl
All patients receive 25 mg of intravenous (IV) diphenhydramine.
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide (Reglan) | Active comparator | Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine. Receives: Drug: Metoclopramide; Other: Normal Saline; Drug: Diphenhydramine |
| Haloperidol (Haldol) | Experimental | Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine. Receives: Drug: Haloperidol; Other: Normal Saline; Drug: Diphenhydramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score According to the Numeric Pain Intensity Scale
Numeric Pain Intensity scale is a standard rating tool for pain, ranging from 0-10, with 0=no pain and 10=worst pain imaginable.
Measured: Change from baseline (prior to treatment) to 1 hour post treatment (1 hour)
Secondary outcomes (2)
Need for Additional Medications Used in the Emergency Department (ED)
Need for additional medications in the ED will be evaluated via chart review at 48 hours post discharge
Measured: 48 hours post discharge
Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge
Occurrence of patient return to the ED or other healthcare provider for headache/migraine within 48 hours of ED discharge will be evaluated via chart review at 48 hours post discharge
Measured: 48 hours post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startFeb 2014
- Primary completion24 Apr 2017
- Study completion24 Apr 2017
Why it stopped: PI lapsed institutional training
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Lloyd, OhioHealth
- Investigators
- Christopher Lloyd, D.O., Principal investigator, Attending Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972502
- Sponsor's protocol ID
- 13-0078
- Status last verified
- Sep 2018
- First submitted
- 7 Nov 2016
- Last updated
- 23 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Using Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02972502
- Acronym / sponsor ID
- 13-0078
- Conditions
- Headache, Migraine
- Keywords
- Metoclopramide (Reglan), Haloperidol (Haldol)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI lapsed institutional training
- Enrolment
- 66 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 24 Apr 2017 (actual)
- Study completion
- 24 Apr 2017 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Posted 23 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metoclopramide (Reglan) is a common agent used for relief of headaches in the emergency department (ED).In this study the investigators seek to explore another option for treatment of headaches in the ED, one that may be more efficacious and efficient. Haloperidol (Haldol), a butyrophenone class of medication, is thought to act by affecting the dopamine 2 receptor in the brain.
By exploring haloperidol as an option for treatment, the investigators hope to discover a more efficient and effective medication for the treatment of non-traumatic headaches, thereby decreasing a patient's length of stay in the department and decreasing the rate of return visits for continued discomfort from the same headache. This study could lead to the increased usage of haloperidol as a first line agent in the treatment of prolonged headaches presenting to the ED.
Detailed description
At this time, choice of medications for the treatment of headaches in the ED is still based on personal and patient preferences because no properly constructed trials have been carried out that would allow identification of a superior agent. Metoclopramide (Reglan) is a common agent used for relief of headaches in the ED. Uncontrolled studies have shown successful relief of migraine with metoclopramide of 75%. Further studies have reported success rate of 67% with IV metoclopramide. In this study the investigators seek to explore another option for treatment of headaches in the ED, one that may be more efficacious and efficient. Haloperidol (Haldol), a butyrophenone class of medication, is thought to act by affecting the dopamine 2 receptor in the brain. These receptors are relatively abundant in the brainstem nuclei and sympathetic ganglia and nerves, through which they may regulate autonomic visceral, gastrointestinal, and hemodynamic responses frequently associated with migraine. One study, demonstrated that 4 out of 5 patients felt significant relief in pain intensity with the use of haloperidol, even when other medications had failed. Relapses were rare, and several patients reported that haloperidol interrupted the prolonged, intractable migraine spiral they had suffered for days. Furthermore, a case series of six cases of migraine treated with 5mg of haloperidol IV after a 500 to 1000ml bolus of IV fluids reported complete or substantial relief within 25 to 65 minutes and side effects were reported as minimal.
The investigators hypothesize that Haloperidol is more efficacious than metoclopramide in the treatment of an acute headache or migraine in the ED in regard to a self-reported pain rating scale (Numeric Pain Intensity Scale), need for additional medication, emergency department return rates, and resolution of symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide (Reglan) | Active comparator | Drug: Metoclopramide, Other: Normal Saline, Drug: DiphenhydraminePatients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine. |
| Haloperidol (Haldol) | Experimental | Drug: Haloperidol, Other: Normal Saline, Drug: DiphenhydraminePatients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who present with a headache or migraine with onset less than or equal to 72 hours
Key exclusion criteria (13 listed)
- Known pregnancy
- Breast-feeding women
- Known history of arrhythmias or QT prolongation (450 ms)
- Known adverse effects to haloperidol, diphenhydramine (Benadryl) or metoclopramide
- Subarachnoid hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetoclopramideAlso: ReglanPatients receive 10 mg of intravenous (IV) metoclopramide. | Drug | Metoclopramide (Reglan) |
| HaloperidolAlso: HaldolPatients receive 2.5 mg of IV haloperidol. | Drug | Haloperidol (Haldol) |
| Normal SalineAll patients receive a 1-liter bolus of normal saline (NS) | Other | Haloperidol (Haldol), Metoclopramide (Reglan) |
| DiphenhydramineAlso: BenadrylAll patients receive 25 mg of intravenous (IV) diphenhydramine. | Drug | Haloperidol (Haldol), Metoclopramide (Reglan) |
Primary outcome
Change in Pain Score According to the Numeric Pain Intensity Scale
Time frame: Change from baseline (prior to treatment) to 1 hour post treatment (1 hour)
Numeric Pain Intensity scale is a standard rating tool for pain, ranging from 0-10, with 0=no pain and 10=worst pain imaginable.
2 secondary outcomes
Need for Additional Medications Used in the Emergency Department (ED)
Time frame: 48 hours post discharge
Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge
Time frame: 48 hours post discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Lloyd, D.O. principal investigator
Attending Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoclopramide, Haloperidol and Normal Saline in people with Headache, Migraine, run by OhioHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Score According to the Numeric Pain Intensity Scale (time frame: Change from baseline (prior to treatment) to 1 hour post treatment (1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.