Migraine HeadachePhase 2/3NCT02933060
Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache
A Phase 2/3 study testing Normal saline (1000 mL) in people with Migraine Headache, run by Cooper Norcross Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Headache
- What is being tested?
- Normal saline (1000 mL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 28 Sep 2017
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Fluent in English
- Meets International Classification of Headache Disorders (3rd ed) criteria for migraine headache:
- At least five attacks fulfilling criteria B-D B. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
- 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)
Show all 9Show fewer
- During headache at least one of the following:
- nausea and/or vomiting
- photophobia and phonophobia E. Not better accounted for by another ICHD-3 diagnosis.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cooper Univeristy Hospital
Camden, New Jersey, 08103
About this study
Official title: Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache: a Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Migraine Headache
- Being tested
- Normal saline (1000 mL), Control
- Keywords
- intravenous fluid, headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal saline (1000 mL)Other
ControlOther
| Study group | Role | What they receive |
|---|---|---|
| IV fluid bolus | Experimental | Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes. Receives: Other: Normal saline (1000 mL) |
| 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes
Secondary outcomes (8)
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.
Measured: 120 minutes
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.
Measured: 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
Measured: 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?"
Measured: 48 hours
Percentage of Patients Who Needed Rescue Medications
Need for additional medications for pain control as determined by the treating physician.
Measured: 120 minutes
Length of Stay
Length of emergency department stay
Measured: 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).
Measured: 48 hours
Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes
Patients reporting no nausea or mild nausea
Measured: 60 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startJan 2017
- Primary completion26 Sep 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Jones, Cooper Norcross Health
- Investigators
- Christopher Jones, MD, Principal investigator, Cooper Medical School of Rowan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933060
- Sponsor's protocol ID
- 16-133
- Status last verified
- Jul 2019
- First submitted
- 12 Oct 2016
- Last updated
- 16 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30665504
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Fluid Therapy for the Treatment of Emergency Department Patients With Migraine Headache: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02933060
- Acronym / sponsor ID
- 16-133
- Conditions
- Migraine Headache
- Keywords
- intravenous fluid, headache
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 26 Sep 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV fluid bolus | Experimental | Other: Normal saline (1000 mL)Patients will receive a 1000 ml bolus of normal saline, administered over 60 minutes. |
| Control | Sham comparator | Other: ControlPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 or older
- Fluent in English
- Meets International Classification of Headache Disorders (3rd ed) criteria for migraine headache:
- At least five attacks fulfilling criteria B-D B. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
- Headache has at least two of the following four characteristics:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal saline (1000 mL) | Other | IV fluid bolus |
| Control | Other | Control |
Primary outcome
Verbal Pain Score at 60 Minutes
Time frame: 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.
8 secondary outcomes
Verbal Pain Score at 120 Minutes
Time frame: 120 minutes
Percentage of Patients Free of Pain at 2 Hours
Time frame: 120 minutes
Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes
Time frame: 60 minutes
Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit
Time frame: 48 hours
Percentage of Patients Who Needed Rescue Medications
Time frame: 120 minutes
Length of Stay
Time frame: 1 day
Verbal Pain Score at 48 Hours
Time frame: 48 hours
Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes
Time frame: 60 mins
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30665504Jones 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Jones, MD principal investigator
Cooper Medical School of Rowan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Normal saline (1000 mL) in people with Migraine Headache, run by Cooper Norcross Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Pain Score at 60 Minutes (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02933060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.