Primary Headaches (Includes Migraines, Tension, Cluster Headaches)
Conditions
Keywords
Headaches, Migraines, Tension headaches, Cluster headaches
Brief summary
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.
Interventions
DRUGDroperidol
Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
DRUGMetoclopramide + diphenhydramine
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.
Sponsors
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 years old to 65 years old, diagnosis of primary headache
Exclusion criteria
* Allergy to study medications, pregnant, breast-feeding, prisoners, non-english speaking, not eligible to receive droperidol based on ED protocol (see below), patients in whom head trauma, infection, vascular disorders, and disorders of facial or cranial structures are suspected 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: * Renal failure * Cerebrovascular disease * Diabetes or hypoglycemia * Alcoholism/alcohol abuse * Pituitary insufficiency * Hypothyroidism * Hypothermia * Anorexia * Advanced age (\>65 yrs) * Use of the following medications: digoxin, benzodiazepine, diuretics, IV opiates, or other medications known to prolong the QTc interval.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scale (Numerical Rating Scale for Pain) | Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS) | Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 hours after discharge from ED | 24 hour pain score (follow-up phone call) |
| Adverse Effects | From the time when the treatment is initiated until the 24 hour follow-up phone survey | Frequency of adverse effects in each arm |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Droperidol Droperidol: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes | 11 |
| 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. | 8 |
| Total | 19 |
Baseline characteristics
| Characteristic | Droperidol | Metoclopramide + Diphenhydramine | Total |
|---|---|---|---|
| Age, Continuous | 33.6 years STANDARD_DEVIATION 9.01 | 30.6 years STANDARD_DEVIATION 5.31 | 32.6 years STANDARD_DEVIATION 7.85 |
| Region of Enrollment United States | 11 Participants | 8 Participants | 19 Participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 16 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 8 |
| other Total, other adverse events | 0 / 11 | 0 / 8 |
| serious Total, serious adverse events | 0 / 11 | 0 / 8 |
Outcome results
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
Time frame: Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS)
Population: Data were not collected
Secondary
24 Hour Pain Score
24 hour pain score (follow-up phone call)
Time frame: 24 hours after discharge from ED
Population: Data were not collected
Secondary
Adverse Effects
Frequency of adverse effects in each arm
Time frame: From the time when the treatment is initiated until the 24 hour follow-up phone survey
Population: Data were not collected
Secondary
Length of Stay
Time frame: Participants will be followed for the duration of their emergency department visit after the initiation of treatment (Average Length of stay in minutes)
Population: Data were not collected