Headache
Conditions
Keywords
Headache, Benign Headache
Brief summary
Migraine headache has a 1-year period prevalence in the US of 11.7% and accounts for approximately 1.2 million migraine visits to US emergency departments per year . There are numerous studies that discuss treatment for migraine and other benign headaches within the emergency department (ED), however, there are very few that discuss specifically the use of intravenous fluids (IVF) for headache treatment. Many of these studies look at various options for treating migraine and other benign headaches: treatment options include dopamine antagonists, opioids, non-steroid anti-inflammatory drugs (NSAIDs), triptans, anti-epileptics and ergot derivatives. Comparisons have been done between many of these treatment options with dopamine antagonists appearing to be the most effective, compared to other treatments The dopamine antagonist with the most evidence and availability for benign headaches is prochlorperazine. Given that IVF administration is a common part of treatment regimen for benign headache patients in the emergency department and given the lack of randomized trials in adults, the investigators aim to study the use of IVF on pain reduction in headache patients in the adult ED. There has been one randomized trial in pediatrics that shows IVF may help in patients with migraines, whereas the adult literature has no randomized control trials and a review of data shows that fluids do not help relieve pain in migraine headache patients. This study will include both adult and pediatric patients presenting to the Emergency Department with complaint of benign headache.
Detailed description
This will be a single center, prospective, single blinded randomized controlled trial on a convenience sample of patients presenting to the adult or pediatric ED with a chief complaint of headache. Subjects will only be enrolled when a physician or research assistant who is familiar with the study protocol is available to enroll patients. Written, informed consent will be obtained from each patient. Consent will include a discussion of the risks and benefits. In addition to parental informed consent in the pediatric population, age appropriate verbal assent will be obtained from pediatric subjects. After 30 minutes, the treating provider will be permitted to administer a rescue medication of their choice for further treatment. If there is an untoward event that requires the patient to know which IVF dose was administered, patient will unblinded and will not continue in the study.
Interventions
DRUGNormal Saline 5mL
Control arm subjects will receive Normal Saline 5 mL IV over 1 hour
DRUGNormal Saline 20mL/kg
Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour,
DRUGProchlorperazine 0.15 mg/kg up to 10 mg IV
Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push
DRUGDiphenhydramine 1 mg/kg up to 50 mg IV
Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
Sponsors
University Medical Center of Southern Nevada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
By necessity the subject will be blinded but the RN administering the IV fluids will need to know the rate of infusion.
Intervention model description
This will be a single center, prospective, single blinded randomized controlled trial on a convenience sample of patients presenting to the adult or pediatric ED with a chief complaint of headache.
Eligibility
Sex/Gender
ALL
Age
10 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age 10 to 65 years 2. Temperature less than 100.4 F 3. Normal neurologic exam and normal mental status
Exclusion criteria
1. Pregnant 2. Meningeal signs are present 3. Acute angle closure glaucoma is suspected 4. Head trauma within the previous two weeks 5. Lumbar puncture within the previous two weeks 6. Thunderclap onset of the headache 7. Known allergy to one of the study drugs 8. History of intracranial hypertension 9. Is a prisoner 10. Patient declined informed consent 11. Non-English speaking patient or parent/guardian for pediatric patients 12. Attending provider excludes patient 13. Severe Dehydration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Pain Scores at 60 Minutes | 60 minutes | The primary outcome measure will be the mean reduction in pain scores at 60 min. In other words the pain score at time zero minus the pain score at time 60 minutes. Pain scores are measured 0-100, with 0 being no pain and 100 being maximal pain, on a visual analog scale score. Higher numbers indicate more pain reduction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Admissions | 1 day | The difference between the rates of admission will be measured. |
| Reduction in Nausea Score at 60 Minutes | 60 minutes | The reduction in mean nausea scores will be measured. This is calculated as the nausea score at time zero minus the nausea score at time 60 minutes. Nausea is measured from 0-100 on a visual analog scale with 0 being no nausea and 100 being maximal nausea. Higher numbers indicate more reduction in nausea. |
| Reduction in Pain Score at 30 Minutes | 30 minutes | The mean reduction in pain scores at 30 minutes. This is calculated as the pain score at time zero minus the pain score at time 30 minutes. Pain scores are measured 0-100 on a visual analog scale score, with 0 being no pain and 100 being maximal pain. Higher numbers indicate more pain reduction. |
| Rescue Medication | 60 minutes | The difference between the percentage of patients requiring rescue medications for headache will be measured. Rescue medications are defined as any medication administered to the patient in the emergency department for their headache after the initial medications. |
| Percentage of Patients With Persistent Headache | 24-48 hours after discharge. | The difference between the rates of persistent headache with telephone follow up. |
| Vomiting | 60 minutes | The difference in the percentage of patients in each group who vomit within one hour after the treatment starts. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Treatment Arm Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV.
Normal Saline 5mL: Control arm subjects will receive Normal Saline 5 mL IV over 1 hour
Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push
Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push | 23 |
| Study Arm Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV.
Normal Saline 20mL/kg: Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour,
Prochlorperazine 0.15 mg/kg up to 10 mg IV: Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push
Diphenhydramine 1 mg/kg up to 50 mg IV: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push | 35 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Standard Treatment Arm | Study Arm | Total |
|---|---|---|---|
| Age, Continuous | 31.7 years STANDARD_DEVIATION 14.7 | 32.3 years STANDARD_DEVIATION 14.1 | 32.0 years STANDARD_DEVIATION 14.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 12 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 23 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 23 participants | 35 participants | 58 participants |
| Sex: Female, Male Female | 17 Participants | 20 Participants | 37 Participants |
| Sex: Female, Male Male | 6 Participants | 15 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 35 |
| other Total, other adverse events | 0 / 23 | 0 / 35 |
| serious Total, serious adverse events | 0 / 23 | 0 / 35 |
Outcome results
Primary
Reduction in Pain Scores at 60 Minutes
The primary outcome measure will be the mean reduction in pain scores at 60 min. In other words the pain score at time zero minus the pain score at time 60 minutes. Pain scores are measured 0-100, with 0 being no pain and 100 being maximal pain, on a visual analog scale score. Higher numbers indicate more pain reduction.
Time frame: 60 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment Arm | Reduction in Pain Scores at 60 Minutes | 48.7 reduction in visual analog pain score | Standard Deviation 29.3 |
| Study Arm | Reduction in Pain Scores at 60 Minutes | 48.3 reduction in visual analog pain score | Standard Deviation 31 |
Secondary
Admissions
The difference between the rates of admission will be measured.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Treatment Arm | Admissions | 0 Participants |
| Study Arm | Admissions | 2 Participants |
Secondary
Percentage of Patients With Persistent Headache
The difference between the rates of persistent headache with telephone follow up.
Time frame: 24-48 hours after discharge.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Treatment Arm | Percentage of Patients With Persistent Headache | 4 Participants |
| Study Arm | Percentage of Patients With Persistent Headache | 11 Participants |
Secondary
Reduction in Nausea Score at 60 Minutes
The reduction in mean nausea scores will be measured. This is calculated as the nausea score at time zero minus the nausea score at time 60 minutes. Nausea is measured from 0-100 on a visual analog scale with 0 being no nausea and 100 being maximal nausea. Higher numbers indicate more reduction in nausea.
Time frame: 60 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment Arm | Reduction in Nausea Score at 60 Minutes | 31.8 reduction in nausea score | Standard Deviation 33.4 |
| Study Arm | Reduction in Nausea Score at 60 Minutes | 25.2 reduction in nausea score | Standard Deviation 34.2 |
Secondary
Reduction in Pain Score at 30 Minutes
The mean reduction in pain scores at 30 minutes. This is calculated as the pain score at time zero minus the pain score at time 30 minutes. Pain scores are measured 0-100 on a visual analog scale score, with 0 being no pain and 100 being maximal pain. Higher numbers indicate more pain reduction.
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment Arm | Reduction in Pain Score at 30 Minutes | 34.8 change in pain score | Standard Deviation 29.6 |
| Study Arm | Reduction in Pain Score at 30 Minutes | 31.8 change in pain score | Standard Deviation 27.1 |
Secondary
Rescue Medication
The difference between the percentage of patients requiring rescue medications for headache will be measured. Rescue medications are defined as any medication administered to the patient in the emergency department for their headache after the initial medications.
Time frame: 60 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Treatment Arm | Rescue Medication | 3 Participants |
| Study Arm | Rescue Medication | 7 Participants |
Secondary
Vomiting
The difference in the percentage of patients in each group who vomit within one hour after the treatment starts.
Time frame: 60 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Treatment Arm | Vomiting | 0 Participants |
| Study Arm | Vomiting | 0 Participants |