Trial Outcomes & Findings for Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache (NCT NCT02933060)
NCT ID: NCT02933060
Last Updated: 2019-07-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
50 participants
Primary outcome timeframe
60 minutes
Results posted on
2019-07-16
Participant Flow
Participant milestones
| Measure |
IV Fluid Bolus
Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
Normal saline (1000 mL)
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
IV Fluid Bolus
Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
Normal saline (1000 mL)
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache
Baseline characteristics by cohort
| Measure |
IV Fluid Bolus
n=25 Participants
Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
Normal saline (1000 mL)
|
Control
n=24 Participants
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
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
n=5 Participants
|
37 years
n=7 Participants
|
35 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Baseline Verbal Pain Score; median (IQR)
|
8 Units on a scale
n=5 Participants
|
9 Units on a scale
n=7 Participants
|
9 Units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 minutesThe 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.
Outcome measures
| Measure |
IV Fluid Bolus
n=25 Participants
Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
Normal saline (1000 mL)
|
Control
n=24 Participants
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
|
|---|---|---|
|
Verbal Pain Score at 60 Minutes
|
4.5 units on a scale (0-10)
Interval 3.7 to 5.3
|
4.9 units on a scale (0-10)
Interval 3.5 to 6.2
|
SECONDARY outcome
Timeframe: 120 minutesThe 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.
Outcome measures
| Measure |
IV Fluid Bolus
n=24 Participants
Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
Normal saline (1000 mL)
|
Control
n=22 Participants
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
|
|---|---|---|
|
Verbal Pain Score at 120 Minutes
|
5.9 units on a scale (0-10)
Interval 4.8 to 7.1
|
5.5 units on a scale (0-10)
Interval 4.1 to 6.8
|
SECONDARY outcome
Timeframe: 120 minutesPercentage of patients in each group who are pain-free two hours after initiation of the study intervention.
Outcome measures
| Measure |
IV Fluid Bolus
n=24 Participants
Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
Normal saline (1000 mL)
|
Control
n=22 Participants
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
|
|---|---|---|
|
Percentage of Patients Free of Pain at 2 Hours
|
38 percentage of participants
|
32 percentage of participants
|
SECONDARY outcome
Timeframe: 60 minutesPercentage 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
Outcome measures
| Measure |
IV Fluid Bolus
n=25 Participants
Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
Normal saline (1000 mL)
|
Control
n=24 Participants
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
|
|---|---|---|
|
Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes
|
72 percentage of participants
|
75 percentage of participants
|
SECONDARY outcome
Timeframe: 48 hoursPercentage 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?"
Outcome measures
| Measure |
IV Fluid Bolus
n=24 Participants
Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
Normal saline (1000 mL)
|
Control
n=21 Participants
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
|
|---|---|---|
|
Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit
|
79 percentage of participants
|
67 percentage of participants
|
SECONDARY outcome
Timeframe: 120 minutesNeed for additional medications for pain control as determined by the treating physician.
Outcome measures
| Measure |
IV Fluid Bolus
n=24 Participants
Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
Normal saline (1000 mL)
|
Control
n=22 Participants
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
|
|---|---|---|
|
Percentage of Patients Who Needed Rescue Medications
|
21 percentage of participants
|
32 percentage of participants
|
SECONDARY outcome
Timeframe: 1 dayLength of emergency department stay
Outcome measures
| Measure |
IV Fluid Bolus
n=25 Participants
Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
Normal saline (1000 mL)
|
Control
n=24 Participants
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
|
|---|---|---|
|
Length of Stay
|
309 minutes
Standard Deviation 68
|
316 minutes
Standard Deviation 93
|
SECONDARY outcome
Timeframe: 48 hoursCurrent pain as reported by participants at 48 hour follow-up (0-10 verbal scale; 0 = No Pain, 10 = Maximum Pain).
Outcome measures
| Measure |
IV Fluid Bolus
n=24 Participants
Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
Normal saline (1000 mL)
|
Control
n=21 Participants
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
|
|---|---|---|
|
Verbal Pain Score at 48 Hours
|
2.6 units on a scale (0-10)
Standard Deviation 3.3
|
1.9 units on a scale (0-10)
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 60 minsPatients reporting no nausea or mild nausea
Outcome measures
| Measure |
IV Fluid Bolus
n=25 Participants
Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
Normal saline (1000 mL)
|
Control
n=24 Participants
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
|
|---|---|---|
|
Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes
|
88 percentage of participants
|
96 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 minutesPain at IV insertion site (0 = No Pain, 10 = Maximum Pain)
Outcome measures
| Measure |
IV Fluid Bolus
n=24 Participants
Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.
Normal saline (1000 mL)
|
Control
n=22 Participants
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
|
|---|---|---|
|
Verbal Report of Insertion Site Pain Score at 60 Minutes
|
0.42 units on a scale (0-10)
Standard Deviation 0.97
|
0.73 units on a scale (0-10)
Standard Deviation 1.32
|
Adverse Events
IV Fluid Bolus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place