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Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02933060
Recruitment Status : Completed
First Posted : October 14, 2016
Results First Posted : June 3, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Christopher Jones, The Cooper Health System

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Migraine Headache
Interventions Other: Normal saline (1000 mL)
Other: Control
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV Fluid Bolus Control
Hide Arm/Group Description

Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.

Normal saline (1000 mL)

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

Period Title: Overall Study
Started 25 25
Completed 25 24
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title IV Fluid Bolus Control Total
Hide Arm/Group Description

Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.

Normal saline (1000 mL)

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 of all reporting groups
Overall Number of Baseline Participants 25 24 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 25 participants 24 participants 49 participants
34
(25 to 40)
37
(30 to 50)
35
(28 to 49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 49 participants
Female
19
  76.0%
22
  91.7%
41
  83.7%
Male
6
  24.0%
2
   8.3%
8
  16.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 49 participants
Hispanic or Latino
10
  40.0%
7
  29.2%
17
  34.7%
Not Hispanic or Latino
13
  52.0%
17
  70.8%
30
  61.2%
Unknown or Not Reported
2
   8.0%
0
   0.0%
2
   4.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 49 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  40.0%
8
  33.3%
18
  36.7%
White
10
  40.0%
10
  41.7%
20
  40.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
  20.0%
6
  25.0%
11
  22.4%
Baseline Verbal Pain Score; median (IQR)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 25 participants 24 participants 49 participants
8
(7 to 10)
9
(8 to 10)
9
(7.5 to 10)
[1]
Measure Description: (0 = no pain, 10 = maximum pain)
1.Primary Outcome
Title Verbal Pain Score at 60 Minutes
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Fluid Bolus Control
Hide Arm/Group Description:

Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.

Normal saline (1000 mL)

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 Number of Participants Analyzed 25 24
Mean (95% Confidence Interval)
Unit of Measure: units on a scale (0-10)
4.5
(3.7 to 5.3)
4.9
(3.5 to 6.2)
2.Secondary Outcome
Title Verbal Pain Score at 120 Minutes
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Fluid Bolus Control
Hide Arm/Group Description:

Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.

Normal saline (1000 mL)

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 Number of Participants Analyzed 24 22
Mean (95% Confidence Interval)
Unit of Measure: units on a scale (0-10)
5.9
(4.8 to 7.1)
5.5
(4.1 to 6.8)
3.Secondary Outcome
Title Percentage of Patients Free of Pain at 2 Hours
Hide Description Percentage of patients in each group who are pain-free two hours after initiation of the study intervention.
Time Frame 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Fluid Bolus Control
Hide Arm/Group Description:

Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.

Normal saline (1000 mL)

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 Number of Participants Analyzed 24 22
Measure Type: Number
Unit of Measure: percentage of participants
38 32
4.Secondary Outcome
Title Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Fluid Bolus Control
Hide Arm/Group Description:

Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.

Normal saline (1000 mL)

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 Number of Participants Analyzed 25 24
Measure Type: Number
Unit of Measure: percentage of participants
72 75
5.Secondary Outcome
Title Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Fluid Bolus Control
Hide Arm/Group Description:

Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.

Normal saline (1000 mL)

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 Number of Participants Analyzed 24 21
Measure Type: Number
Unit of Measure: percentage of participants
79 67
6.Secondary Outcome
Title Percentage of Patients Who Needed Rescue Medications
Hide Description Need for additional medications for pain control as determined by the treating physician.
Time Frame 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Fluid Bolus Control
Hide Arm/Group Description:

Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.

Normal saline (1000 mL)

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 Number of Participants Analyzed 24 22
Measure Type: Number
Unit of Measure: percentage of participants
21 32
7.Secondary Outcome
Title Length of Stay
Hide Description Length of emergency department stay
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Fluid Bolus Control
Hide Arm/Group Description:

Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.

Normal saline (1000 mL)

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 Number of Participants Analyzed 25 24
Mean (Standard Deviation)
Unit of Measure: minutes
309  (68) 316  (93)
8.Secondary Outcome
Title Verbal Pain Score at 48 Hours
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Fluid Bolus Control
Hide Arm/Group Description:

Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.

Normal saline (1000 mL)

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 Number of Participants Analyzed 24 21
Mean (Standard Deviation)
Unit of Measure: units on a scale (0-10)
2.6  (3.3) 1.9  (2.5)
9.Secondary Outcome
Title Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes
Hide Description Patients reporting no nausea or mild nausea
Time Frame 60 mins
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Fluid Bolus Control
Hide Arm/Group Description:

Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.

Normal saline (1000 mL)

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 Number of Participants Analyzed 25 24
Measure Type: Number
Unit of Measure: percentage of participants
88 96
10.Other Pre-specified Outcome
Title Verbal Report of Insertion Site Pain Score at 60 Minutes
Hide Description Pain at IV insertion site (0 = No Pain, 10 = Maximum Pain)
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Fluid Bolus Control
Hide Arm/Group Description:

Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.

Normal saline (1000 mL)

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 Number of Participants Analyzed 24 22
Mean (Standard Deviation)
Unit of Measure: units on a scale (0-10)
0.42  (0.97) 0.73  (1.32)
Time Frame 48 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Fluid Bolus Control
Hide Arm/Group Description

Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes.

Normal saline (1000 mL)

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

All-Cause Mortality
IV Fluid Bolus Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/24 (0.00%) 
Hide Serious Adverse Events
IV Fluid Bolus Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/24 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV Fluid Bolus Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/24 (0.00%) 
This was a small-scale pilot study. The wide confidence intervals we observed do not exclude the possibility of a clinically relevant treatment effect.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Christopher Jones
Organization: Cooper University Health System
Phone: 856-342-2627
EMail: jones-christopher@cooperhealth.edu
Layout table for additonal information
Responsible Party: Christopher Jones, The Cooper Health System
ClinicalTrials.gov Identifier: NCT02933060    
Other Study ID Numbers: 16-133
First Submitted: October 12, 2016
First Posted: October 14, 2016
Results First Submitted: October 17, 2018
Results First Posted: June 3, 2019
Last Update Posted: July 16, 2019