The Effect of Intravenous Fluid Therapy in Acute Migraine Attacks
NCT ID: NCT04287140
Last Updated: 2020-12-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-04-01
Study Completion Date
2021-11-01
Brief Summary
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The study is a single-center, double-blind, randomized protocol comparison. The study will be conducted in Marmara University School of Medicine Pendik Training and Research Hospital, Department of Emergency Medicine between April 2020 and October 2020.
The population consists of non-pregnant, adult patients (age of 18 or more) who will be confirmed as migraine according to The International Classification of Headache Disorders 3rd edition (ICHD-3) in the emergency department (ED). After the patient was found suitable for the standard treatment protocol, they will be randomized to receive a 1000 ml bolus of normal saline for 1 hour or normal saline at 10 cc/h for 1 hour. The pain level, functional status, and side effects will be assessed before the beginning, at the 1st hour, 2nd hour and at the 24th hour.
The objective of this study is to determine the effect of an intravenous (IV) fluid bolus on migraine headache among patients treated in the ED.
The population consists of non-pregnant, adult patients (age of 18 or more) who will be confirmed as migraine according to The International Classification of Headache Disorders 3rd edition (ICHD-3) in the emergency department (ED). After the patient was found suitable for the standard treatment protocol, they will be randomized to receive a 1000 ml bolus of normal saline for 1 hour or normal saline at 10 cc/h for 1 hour. The pain level, functional status, and side effects will be assessed before the beginning, at the 1st hour, 2nd hour and at the 24th hour.
The objective of this study is to determine the effect of an intravenous (IV) fluid bolus on migraine headache among patients treated in the ED.
Detailed Description
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Introduction Headache is a common complaint that is seen in 70-80% of the population and is a common health problem in emergency services. When evaluating the patient with headache, the first step is to determine whether the headache is primary or secondary (1, 2). Primary headaches are classified according to their symptoms and clinical features. Tension-type headache, migraine, and cluster headache are the most common types of primary headaches (3). Secondary headaches can be classified as headaches due to the head and neck trauma, headaches secondary to neurovascular diseases, and headaches due to withdrawal syndromes secondary to drug abuse (4). Migraine is a primary type of headache characterized by recurrent throbbing (usually unilateral) and associated with photophobia, phonophobia, nausea, and other symptoms. Patients with migraine are usually not pleased with the treatment options due to headaches refractory to treatment (5).
The current approach to the treatment of migraine headaches consists of two components: treatment of the acute migraine attacks, and prophylactic treatment.
According to the World Health Organization (WHO), migraine attacks are the eighth cause of loss of work and performance in the attack period among all lifelong diseases (12). Therefore, effective treatment of migraine attacks is important for the patient and socioeconomic wellbeing of the community. More than 90% of the migraine patients experience acute migraine attacks despite prophylactic treatment and need pain medications (6). Common treatment options used in the ED are phenothiazines (7), serotonin receptor agonists (8), and corticosteroids (9). Headache guideline of the American Academy of Neurology published in 2000 also recommends diclofenac as an effective alternative for the treatment of acute migraine attacks (10, 11). Effective attack therapy has the potential to significantly reduce inefficiency caused by migraine attacks by shortening the duration and reducing the severity of attacks.
Although clinical evidence is uncertain, approximately 40% of patients presenting to the ED with a headache are treated with IV fluids (13). Studies with healthy volunteers showed that mild dehydration reduces the pain threshold and increases central pain-related activity in the anterior cingulate cortex, insula, and thalamus (14). Therefore, it is logical to think that dehydration may trigger acute migraine attacks (15). This led to the common approach to use IV fluids besides pain medications in the ED as a routine procedure. A clear benefit would obviously increase the satisfaction of the patient from the ED services, by increasing the pain threshold, decreasing length of stay, and need for rescue treatment. However, on the contrary, IV fluid therapy without an obvious benefit to the patient has a cost burden on the system, uses labor and time of the ED staff, and may increase the duration of the length of stay in the ED.
Therefore, the aim of this study is to evaluate the efficacy and side effects related to the addition of 1000 cc bolus NS to the standard treatment of migraine in the ED.
The current approach to the treatment of migraine headaches consists of two components: treatment of the acute migraine attacks, and prophylactic treatment.
According to the World Health Organization (WHO), migraine attacks are the eighth cause of loss of work and performance in the attack period among all lifelong diseases (12). Therefore, effective treatment of migraine attacks is important for the patient and socioeconomic wellbeing of the community. More than 90% of the migraine patients experience acute migraine attacks despite prophylactic treatment and need pain medications (6). Common treatment options used in the ED are phenothiazines (7), serotonin receptor agonists (8), and corticosteroids (9). Headache guideline of the American Academy of Neurology published in 2000 also recommends diclofenac as an effective alternative for the treatment of acute migraine attacks (10, 11). Effective attack therapy has the potential to significantly reduce inefficiency caused by migraine attacks by shortening the duration and reducing the severity of attacks.
Although clinical evidence is uncertain, approximately 40% of patients presenting to the ED with a headache are treated with IV fluids (13). Studies with healthy volunteers showed that mild dehydration reduces the pain threshold and increases central pain-related activity in the anterior cingulate cortex, insula, and thalamus (14). Therefore, it is logical to think that dehydration may trigger acute migraine attacks (15). This led to the common approach to use IV fluids besides pain medications in the ED as a routine procedure. A clear benefit would obviously increase the satisfaction of the patient from the ED services, by increasing the pain threshold, decreasing length of stay, and need for rescue treatment. However, on the contrary, IV fluid therapy without an obvious benefit to the patient has a cost burden on the system, uses labor and time of the ED staff, and may increase the duration of the length of stay in the ED.
Therefore, the aim of this study is to evaluate the efficacy and side effects related to the addition of 1000 cc bolus NS to the standard treatment of migraine in the ED.
Conditions
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Migraine Disorders
Headache
Acute Pain
Keywords
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migraine
pain
normal saline
diclofenac
emergency department
adult
acute attack
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment Secondary Purpose: Adverse Event
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
The fluid bag, intravenous pump, serum set will be concealed with opaque coaters, so that patients, doctors, and study investigators will be blinded to the treatment group. Only the nurse who sets the infusion pump will be aware of the treatment group of the patient.
Study Groups
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Saline
1000 ml of 0.9% normal saline bolus over one hour.
Group Type
EXPERIMENTAL
Bolus fluid administration
Intervention Type
OTHER
1000 ml of 0.9% normal saline bolus over one hour
No Saline
10 ml of 0.9% normal saline over one hour.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Bolus fluid administration
1000 ml of 0.9% normal saline bolus over one hour
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* age 18 years or older
* migraine with or without aura according to International Classification of Headache Disorders-3 (ICHD-3) diagnostic criteria confirmed by one-to-one physical exam in the ED
* no declaration and sign of pregnancy, or pregnancy not diagnosed during the ED evaluation before randomization,
* did not receive any IV fluid of 100 cc or more at any facility in the last 12 hours,
* intramuscular diclofenac potassium 75 mg, the standard treatment protocol, is ordered by the physician (no history of known allergic reaction to diclofenac potassium),
* severe dehydration not present as determined by the researcher (hypotension, dry mouth, tongue and eyeballs, decreased urine output)
* no other indication for fluid infusion,
* no contraindication to fluid administration (heart failure patients with diuretic use, renal failure patients with fluid restriction, hemodynamic instability),
* do not have accompanying symptoms and signs related to headaches secondary to other obvious pathologies rather than migraine,
* consent to be included in the study.
* migraine with or without aura according to International Classification of Headache Disorders-3 (ICHD-3) diagnostic criteria confirmed by one-to-one physical exam in the ED
* no declaration and sign of pregnancy, or pregnancy not diagnosed during the ED evaluation before randomization,
* did not receive any IV fluid of 100 cc or more at any facility in the last 12 hours,
* intramuscular diclofenac potassium 75 mg, the standard treatment protocol, is ordered by the physician (no history of known allergic reaction to diclofenac potassium),
* severe dehydration not present as determined by the researcher (hypotension, dry mouth, tongue and eyeballs, decreased urine output)
* no other indication for fluid infusion,
* no contraindication to fluid administration (heart failure patients with diuretic use, renal failure patients with fluid restriction, hemodynamic instability),
* do not have accompanying symptoms and signs related to headaches secondary to other obvious pathologies rather than migraine,
* consent to be included in the study.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Marmara University
OTHER
Sponsor Role
lead
Responsible Party
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Haldun Akoglu
Professor of Emergency Medicine
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Haldun Akoglu, MD., Prof.
Role: STUDY_DIRECTOR
Marmara University
Locations
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Marmara University Pendik Education and Research Hospital
Istanbul, , Turkey (Türkiye)
Site Status
RECRUITING
Countries
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Turkey (Türkiye)
Central Contacts
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Facility Contacts
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Yusuf Turan, MD
Role: primary
References
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Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
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Other Identifiers
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09.2019.497
Identifier Type: -
Identifier Source: org_study_id