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PI lapsed institutional training
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoclopramide | Drug | Patients receive 10 mg of intravenous (IV) metoclopramide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline (prior to treatment) to 1 hour post treatment (1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Lloyd, D.O. | Attending Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OhioHealth Doctors Hospital | Columbus | Ohio | 43228 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline (prior to treatment) to 1 hour post treatment (1 hour) |
|
48 hours
Study was terminated early. Some information entered for n=49 participants. Data not collected for 11 participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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This study was terminated by the IRB due to PI lapse in required training. Outcomes data reported includes preliminary figures for n=49 patients. Data not collected from 11 patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Blessing, PhD | OhioHealth Research Institute | (513) 461-1772 | chelsea.blessing@ohiohealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2016 | Jul 19, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| D006220 | Haloperidol |
| D000077330 | Saline Solution |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
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| Haloperidol | Drug | Patients receive 2.5 mg of IV haloperidol. |
|
|
| Normal Saline | Other | All patients receive a 1-liter bolus of normal saline (NS) |
|
| Diphenhydramine | Drug | All patients receive 25 mg of intravenous (IV) diphenhydramine. |
|
|
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 |
| 48 hours post discharge |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Pain Score | Baseline Pain Score derived from Numeric Pain Intensity Scale. This scale is a patient-reported numeric measure of pain, from 0 [no pain] to 10 [worst pain imaginable.] | Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
| 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 | Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants. | Posted | Count of Participants | Participants | 48 hours post discharge |
|
|
|
| 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 | Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants. | Posted | Count of Participants | Participants | 48 hours post discharge |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | 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. | 0 | 23 | 0 | 23 | 0 | 23 |
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| D009422 | Nervous System Diseases |
| D062365 |
| Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D005021 | Ethylamines |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| Somali |
|
| Hispanic |
|
| Unknown |
|