Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| University of Iowa |
Not provided
Not provided
Not provided
lack of enrollment/drug shortages
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if droperidol is equally as effective as metoclopramide for treatment of primary headaches in the Emergency Department.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Droperidol | Experimental |
| |
| Metoclopramide + Diphenhydramine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Droperidol | Drug | Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scale (Numerical Rating Scale for Pain) | Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain | Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Participants will be followed for the duration of their emergency department visit after the initiation of treatment (Average Length of stay in minutes) | |
| 24 Hour Pain Score | 24 hour pain score (follow-up phone call) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
ED Droperidol Protocol
Droperidol must NOT be used in patients with any of the following:
Known or suspected QT prolongation, including congenital long QT syndrome
Cardiac Disease [cardiomyopathy, congestive heart failure, hypertension, ischemic heart disease, myocardial infarction, bradycardia (< 50 bpm)]
History of the following:
Advanced age (>65 yrs)
Use of the following medications: digoxin, benzodiazepine, diuretics, IV opiates, or other medications known to prolong the QTc interval.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jon Van Heukelom, MD | University of Iowa | Principal Investigator |
| Christopher Hogrefe, MD | University of Iowa | Principal Investigator |
| Brett Faine, PharmD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Droperidol | Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes |
| FG001 | Metoclopramide + Diphenhydramine | Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Droperidol | Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes |
| BG001 | Metoclopramide + Diphenhydramine | Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses. Diphenhydramine: Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion. |
| 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 | Pain Scale (Numerical Rating Scale for Pain) | Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain | Data were not collected | Posted | Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Droperidol | Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett Faine | University of Iowa Hospitals and Clinics | 3193108067 | brett-faine@uiowa.edu |
Not provided
| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| D006261 | Headache |
| D008881 | Migraine Disorders |
| D018781 | Tension-Type Headache |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004329 | Droperidol |
| D008787 | Metoclopramide |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Metoclopramide + diphenhydramine |
| Drug |
Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion. |
|
| 24 hours after discharge from ED |
| Adverse Effects | Frequency of adverse effects in each arm | From the time when the treatment is initiated until the 24 hour follow-up phone survey |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Secondary | Length of Stay | Data were not collected | Posted | Participants will be followed for the duration of their emergency department visit after the initiation of treatment (Average Length of stay in minutes) |
|
|
| Secondary | 24 Hour Pain Score | 24 hour pain score (follow-up phone call) | Data were not collected | Posted | 24 hours after discharge from ED |
|
|
| Secondary | Adverse Effects | Frequency of adverse effects in each arm | Data were not collected | Posted | From the time when the treatment is initiated until the 24 hour follow-up phone survey |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Metoclopramide | Metoclopramide: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses. Diphenhydramine: Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion. | 0 | 8 | 0 | 8 | 0 | 8 |
Not provided
Not provided
Not provided
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001549 | Benzamides |
| D000577 | Amides |
| D062366 | para-Aminobenzoates |
| 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 |
| D005021 | Ethylamines |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |