Migraine Headache
Conditions
Keywords
intravenous fluid, headache
Brief summary
The purpose of this study is to determine whether patients in the emergency department with migraine headache who are administered an intravenous fluid bolus will report greater improvement in pain scores than control patients.
Detailed description
The investigators intend to perform a small-scale pilot study assessing the effectiveness of IV fluid therapy for patients presenting to the ED with migraine headache. Patients will be randomly allocated to receive a bolus of 1000 ml normal saline or no fluid bolus. Patients and outcome assessors will be blinded to the assigned study group. Research assistants will assess pain scores, nausea, and functional disability at time 0 (just prior to starting the intervention), 60 minutes, and 120 minutes. Participants will be contacted 48 hours after leaving the ED to assess symptom burden following discharge.
Interventions
OTHERNormal saline (1000 mL)
OTHERControl
Sponsors
The Cooper Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Fluent in English * Meets International Classification of Headache Disorders (3rd ed) criteria for migraine headache: A. At least five attacks fulfilling criteria B-D B. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated) C. Headache has at least two of the following four characteristics: unilateral location pulsating quality moderate or severe pain intensity aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) D. During headache at least one of the following: 1. nausea and/or vomiting 2. photophobia and phonophobia E. Not better accounted for by another ICHD-3 diagnosis.
Exclusion criteria
* Intravenous Fluids are contraindicated in the opinion of the emergency department physician caring for the patient (ex patient has an exacerbation of congestive heart failure). * Intravenous fluids are required in the opinion of the emergency department physician caring for the patient (ex patient has intractable vomiting, patient has severe dehydration). * Have already received greater than or equal to 500 ml of intravenous fluid during this emergency department visit, prior to enrollment. * Currently pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Pain Score at 60 Minutes | 60 minutes | The primary outcome will be the difference in verbal pain rating (0 = no pain, 10 = maximum pain) between the start of the study intervention and one hour later, at completion of the intervention. The minimum clinically significant difference between treatment groups on the 0-10 verbal scale is 1.3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Pain Score at 120 Minutes | 120 minutes | The difference in verbal pain rating (0 = no pain, 10 = maximum pain) between the start of the study intervention and 2 hours later. The minimum clinically significant difference between treatment groups on the 0-10 verbal scale is 1.3. |
| Percentage of Patients Free of Pain at 2 Hours | 120 minutes | Percentage of patients in each group who are pain-free two hours after initiation of the study intervention. |
| Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes | 60 minutes | Percentage of patients with functional disability due to headache rated as none or mild (able to perform all activities of daily living, but with some difficulty) at 60 minutes |
| Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit | 48 hours | Percentage of participants answering yes to the question: The next time you visit the ED with a headache, would you wish to receive the same IV fluid treatment again? |
| Length of Stay | 1 day | Length of emergency department stay |
| Verbal Pain Score at 48 Hours | 48 hours | Current pain as reported by participants at 48 hour follow-up (0-10 verbal scale; 0 = No Pain, 10 = Maximum Pain). |
| Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes | 60 mins | Patients reporting no nausea or mild nausea |
| Percentage of Patients Who Needed Rescue Medications | 120 minutes | Need for additional medications for pain control as determined by the treating physician. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Verbal Report of Insertion Site Pain Score at 60 Minutes | 60 minutes | Pain at IV insertion site (0 = No Pain, 10 = Maximum Pain) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IV Fluid Bolus Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
Normal saline (1000 mL) | 25 |
| Control Patients will have an IV catheter and will be connected to an IV bag, but will receive only 10 ml of normal saline over 60 minutes.
Control | 24 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | IV Fluid Bolus | Control | Total |
|---|---|---|---|
| Age, Continuous | 34 years | 37 years | 35 years |
| Baseline Verbal Pain Score; median (IQR) | 8 Units on a scale | 9 Units on a scale | 9 Units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 7 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 17 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 8 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 6 Participants | 11 Participants |
| Race (NIH/OMB) White | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Female | 19 Participants | 22 Participants | 41 Participants |
| Sex: Female, Male Male | 6 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 0 / 25 | 0 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 |
Outcome results
Primary
Verbal Pain Score at 60 Minutes
The primary outcome will be the difference in verbal pain rating (0 = no pain, 10 = maximum pain) between the start of the study intervention and one hour later, at completion of the intervention. The minimum clinically significant difference between treatment groups on the 0-10 verbal scale is 1.3.
Time frame: 60 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IV Fluid Bolus | Verbal Pain Score at 60 Minutes | 4.5 units on a scale (0-10) |
| Control | Verbal Pain Score at 60 Minutes | 4.9 units on a scale (0-10) |
Secondary
Length of Stay
Length of emergency department stay
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Fluid Bolus | Length of Stay | 309 minutes | Standard Deviation 68 |
| Control | Length of Stay | 316 minutes | Standard Deviation 93 |
Secondary
Percentage of Patients Free of Pain at 2 Hours
Percentage of patients in each group who are pain-free two hours after initiation of the study intervention.
Time frame: 120 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Fluid Bolus | Percentage of Patients Free of Pain at 2 Hours | 38 percentage of participants |
| Control | Percentage of Patients Free of Pain at 2 Hours | 32 percentage of participants |
Secondary
Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes
Patients reporting no nausea or mild nausea
Time frame: 60 mins
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Fluid Bolus | Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes | 88 percentage of participants |
| Control | Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes | 96 percentage of participants |
Secondary
Percentage of Patients Who Needed Rescue Medications
Need for additional medications for pain control as determined by the treating physician.
Time frame: 120 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Fluid Bolus | Percentage of Patients Who Needed Rescue Medications | 21 percentage of participants |
| Control | Percentage of Patients Who Needed Rescue Medications | 32 percentage of participants |
Secondary
Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit
Percentage of participants answering yes to the question: The next time you visit the ED with a headache, would you wish to receive the same IV fluid treatment again?
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Fluid Bolus | Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit | 79 percentage of participants |
| Control | Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit | 67 percentage of participants |
Secondary
Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes
Percentage of patients with functional disability due to headache rated as none or mild (able to perform all activities of daily living, but with some difficulty) at 60 minutes
Time frame: 60 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Fluid Bolus | Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes | 72 percentage of participants |
| Control | Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes | 75 percentage of participants |
Secondary
Verbal Pain Score at 120 Minutes
The difference in verbal pain rating (0 = no pain, 10 = maximum pain) between the start of the study intervention and 2 hours later. The minimum clinically significant difference between treatment groups on the 0-10 verbal scale is 1.3.
Time frame: 120 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IV Fluid Bolus | Verbal Pain Score at 120 Minutes | 5.9 units on a scale (0-10) |
| Control | Verbal Pain Score at 120 Minutes | 5.5 units on a scale (0-10) |
Secondary
Verbal Pain Score at 48 Hours
Current pain as reported by participants at 48 hour follow-up (0-10 verbal scale; 0 = No Pain, 10 = Maximum Pain).
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Fluid Bolus | Verbal Pain Score at 48 Hours | 2.6 units on a scale (0-10) | Standard Deviation 3.3 |
| Control | Verbal Pain Score at 48 Hours | 1.9 units on a scale (0-10) | Standard Deviation 2.5 |
Other Pre-specified
Verbal Report of Insertion Site Pain Score at 60 Minutes
Pain at IV insertion site (0 = No Pain, 10 = Maximum Pain)
Time frame: 60 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Fluid Bolus | Verbal Report of Insertion Site Pain Score at 60 Minutes | 0.42 units on a scale (0-10) | Standard Deviation 0.97 |
| Control | Verbal Report of Insertion Site Pain Score at 60 Minutes | 0.73 units on a scale (0-10) | Standard Deviation 1.32 |