Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV fluid bolus | Experimental | Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes. |
|
| Control | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline (1000 mL) | Other |
| ||
| Control |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 120 minutes |
| Percentage of Patients Free of Pain at 2 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Report of Insertion Site Pain Score at 60 Minutes | Pain at IV insertion site (0 = No Pain, 10 = Maximum Pain) | 60 minutes |
Inclusion Criteria:
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher Jones, MD | Cooper Medical School of Rowan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper Univeristy Hospital | Camden | New Jersey | 08103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30665504 | Derived | Jones CW, Remboski LB, Freeze B, Braz VA, Gaughan JP, McLean SA. Intravenous Fluid for the Treatment of Emergency Department Patients With Migraine Headache: A Randomized Controlled Trial. Ann Emerg Med. 2019 Feb;73(2):150-156. doi: 10.1016/j.annemergmed.2018.09.004. Epub 2018 Oct 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IV Fluid Bolus | Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes. Normal saline (1000 mL) |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IV Fluid Bolus | Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes. Normal saline (1000 mL) |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 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. | Posted | Mean | 95% Confidence Interval | units on a scale (0-10) | 60 minutes |
|
48 hours
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 | IV Fluid Bolus | Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes. Normal saline (1000 mL) |
Not provided
Not provided
This was a small-scale pilot study. The wide confidence intervals we observed do not exclude the possibility of a clinically relevant treatment effect.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Jones | Cooper University Health System | 856-342-2627 | jones-christopher@cooperhealth.edu |
Not provided
| 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 | Feb 8, 2016 | Oct 17, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Percentage of patients in each group who are pain-free two hours after initiation of the study intervention. |
| 120 minutes |
| 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 | 60 minutes |
| 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?" | 48 hours |
| Percentage of Patients Who Needed Rescue Medications | Need for additional medications for pain control as determined by the treating physician. | 120 minutes |
| Length of Stay | Length of emergency department stay | 1 day |
| 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). | 48 hours |
| Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes | Patients reporting no nausea or mild nausea | 60 mins |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline Verbal Pain Score; median (IQR) | (0 = no pain, 10 = maximum pain) | Median | Inter-Quartile Range | Units on a scale |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale (0-10) | 120 minutes |
|
|
|
| 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. | Posted | Number | percentage of participants | 120 minutes |
|
|
|
| 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 | Posted | Number | percentage of participants | 60 minutes |
|
|
|
| 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?" | Posted | Number | percentage of participants | 48 hours |
|
|
|
| Secondary | Percentage of Patients Who Needed Rescue Medications | Need for additional medications for pain control as determined by the treating physician. | Posted | Number | percentage of participants | 120 minutes |
|
|
|
| Secondary | Length of Stay | Length of emergency department stay | Posted | Mean | Standard Deviation | minutes | 1 day |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale (0-10) | 48 hours |
|
|
|
| Secondary | Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes | Patients reporting no nausea or mild nausea | Posted | Number | percentage of participants | 60 mins |
|
|
|
| Other Pre-specified | Verbal Report of Insertion Site Pain Score at 60 Minutes | Pain at IV insertion site (0 = No Pain, 10 = Maximum Pain) | Posted | Mean | Standard Deviation | units on a scale (0-10) | 60 minutes |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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 | 0 | 24 | 0 | 24 | 0 | 24 |
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |