Headache, Migraine
Conditions
Keywords
Metoclopramide (Reglan), Haloperidol (Haldol)
Brief 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. 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.
Interventions
DRUGMetoclopramide
Patients receive 10 mg of intravenous (IV) metoclopramide.
DRUGHaloperidol
Patients receive 2.5 mg of IV haloperidol.
OTHERNormal Saline
All patients receive a 1-liter bolus of normal saline (NS)
DRUGDiphenhydramine
All patients receive 25 mg of intravenous (IV) diphenhydramine.
Sponsors
OhioHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who present with a headache or migraine with onset less than or equal to 72 hours
Exclusion criteria
* 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 * Congestive heart failure * Parkinson's Disease * Dementia * Pheochromocytoma * History of glaucoma * History of seizures * Non-English speaking patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score According to the Numeric Pain Intensity Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for Additional Medications Used in the Emergency Department (ED) | 48 hours post discharge | Need for additional medications in the ED will be evaluated via chart review at 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 | 48 hours post 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metoclopramide (Reglan) Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine. | 31 |
| Haloperidol (Haldol) 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.
Haloperidol: Patients receive 2.5 mg of IV haloperidol.
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine. | 29 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Metoclopramide (Reglan) | Haloperidol (Haldol) | Total |
|---|---|---|---|
| Age, Continuous | 34.5 years STANDARD_DEVIATION 9.9 | 36.9 years STANDARD_DEVIATION 10 | 35.7 years STANDARD_DEVIATION 10 |
| Baseline Pain Score | 8.13 units on a scale STANDARD_DEVIATION 1.36 | 8.54 units on a scale STANDARD_DEVIATION 1.34 | 8.35 units on a scale STANDARD_DEVIATION 1.38 |
| Race/Ethnicity, Customized Race/Ethnicity African American | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 18 Participants | 19 Participants | 37 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Somali | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 31 participants | 29 participants | 60 participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 18 Participants | 14 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 23 |
| other Total, other adverse events | 0 / 26 | 0 / 23 |
| serious Total, serious adverse events | 0 / 26 | 0 / 23 |
Outcome results
Primary
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.
Time frame: Change from baseline (prior to treatment) to 1 hour post treatment (1 hour)
Population: Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metoclopramide (Reglan) | Change in Pain Score According to the Numeric Pain Intensity Scale | -2.86 units on a scale | Standard Deviation 2.37 |
| Haloperidol (Haldol) | Change in Pain Score According to the Numeric Pain Intensity Scale | -5.13 units on a scale | Standard Deviation 2.59 |
Secondary
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
Time frame: 48 hours post discharge
Population: Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metoclopramide (Reglan) | Need for Additional Medications Used in the Emergency Department (ED) | Yes | 7 Participants |
| Metoclopramide (Reglan) | Need for Additional Medications Used in the Emergency Department (ED) | No | 4 Participants |
| Metoclopramide (Reglan) | Need for Additional Medications Used in the Emergency Department (ED) | Unknown | 15 Participants |
| Haloperidol (Haldol) | Need for Additional Medications Used in the Emergency Department (ED) | Unknown | 10 Participants |
| Haloperidol (Haldol) | Need for Additional Medications Used in the Emergency Department (ED) | Yes | 4 Participants |
| Haloperidol (Haldol) | Need for Additional Medications Used in the Emergency Department (ED) | No | 9 Participants |
Secondary
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
Time frame: 48 hours post discharge
Population: Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Metoclopramide (Reglan) | Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge | Yes | 0 Participants |
| Metoclopramide (Reglan) | Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge | No | 26 Participants |
| Haloperidol (Haldol) | Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge | Yes | 0 Participants |
| Haloperidol (Haldol) | Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge | No | 23 Participants |