We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Intravenous Fluid Therapy in Acute Migraine Attacks

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: NCT04287140
Recruitment Status : Unknown
Verified December 2020 by Haldun Akoglu, Marmara University.
Recruitment status was:  Recruiting
First Posted : February 27, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
Haldun Akoglu, Marmara University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Migraine Disorders Headache Acute Pain Other: Bolus fluid administration Not Applicable

Detailed Description:

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment Secondary Purpose: Adverse Event
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: The Utility of Adding 1 L Intravenous Normal Saline to Standard 75 mg Intramuscular Diclofenac Potassium Injection in Patients Presented to the Emergency Department With an Acute Migraine Attack
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Saline
1000 ml of 0.9% normal saline bolus over one hour.
 Other: Bolus fluid administration
1000 ml of 0.9% normal saline bolus over one hour
No Intervention: No Saline
10 ml of 0.9% normal saline over one hour.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. VAS(headache) [ Time Frame: at the 2nd hour ]
    The patient will be asked to place a mark between the 0 and 10 cm points indicated on a 10 cm line, the distance of the marked point to 0 will be taken as the VAS(headache) score in mm.


Secondary Outcome Measures :
  1. VAS(headache) [ Time Frame: at the 1st hour ]
    The patient will be asked to place a mark between the 0 and 10 cm points indicated on a 10 cm line, the distance of the marked point to 0 will be taken as the VAS(headache) score in mm.

  2. VAS(nausea) [ Time Frame: at the 1st hour ]
    The patient will be asked to place a mark between the 0 and 10 cm points indicated on a 10 cm line, the distance of the marked point to 0 will be taken as the VASnausea score in mm.

  3. VAS(nausea) [ Time Frame: at the 2nd hour ]
    The patient will be asked to place a mark between the 0 and 10 cm points indicated on a 10 cm line, the distance of the marked point to 0 will be taken as the VASnausea score in mm.

  4. Level of Functional Disability [ Time Frame: at the 1st hour ]
    Categorized as none, mild (makes it difficult to do daily tasks), moderate (not able to do daily tasks), severe (requires bed rest).

  5. Level of Functional Disability [ Time Frame: at the 2nd hour ]
    Categorized as none, mild (makes it difficult to do daily tasks), moderate (not able to do daily tasks), severe (requires bed rest).

  6. Level of Functional Disability [ Time Frame: at the 24th hour ]
    Categorized as none, mild (makes it difficult to do daily tasks), moderate (not able to do daily tasks), severe (requires bed rest).

  7. Adverse Events [ Time Frame: at the 1st hour ]
    The proportion of patients with the following adverse events in each group will be actively pursued during the administration of treatment at the ED: hypernatremia, fluid retention, high blood pressure, injection site reactions

  8. Adverse Events [ Time Frame: at the 2nd hour ]
    The proportion of patients with the following adverse events in each group will be actively pursued during the administration of treatment at the ED: hypernatremia, fluid retention, high blood pressure, injection site reactions

  9. Adverse Events [ Time Frame: at the 24th hour ]
    The proportion of patients with the following adverse events in each group will be actively pursued during the administration of treatment at the ED: hypernatremia, fluid retention, high blood pressure, injection site reactions

  10. Successful Treatment [ Time Frame: at the 2nd hour ]
    The proportion of patients will successful and failed treatments will be compared between study groups. Successful treatment is defined if VAS(headache) is decreased at least 50% from the highest VAS(headache) reported by the patient at any time-point without the need of additional analgesics and/or antiemetics. Failed treatment is defined if VAS(headache) is decreased not more than 10% from the highest VAS(headache) or patient's declaration that the headache is the same at the 2nd hour. All patients defined as failed treatment will be offered the rescue treatment (analgesic and/or antiemetic).

  11. Time-to-discharge [ Time Frame: 0 to 24 hours ]
    Duration between the time of admission to the emergency department and discharge up to 24 hours.

  12. The presence of headache [ Time Frame: at the 24th hour ]
    The patients will be asked to answer if their headache is still present or not, and will be requested to answer as "yes" or "no".

  13. The recurrence of headache [ Time Frame: at the 24th hour ]
    The patients will be asked to answer if their headache has recurred (may still be present or not) or not, and will be requested to answer as "yes" or "no".

  14. Ability to tolerate oral intake [ Time Frame: at the 24th hour ]
    If the patient could eat a regular meal without vomiting in the 30 minutes after intake, they will be considered as "able to eat". All other conditions will be considered a "no".


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion criteria: no patients will be excluded from the study after randomization. All patients will be evaluated for the primary outcome with an intent-to-treat approach.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04287140


Contacts
Layout table for location contacts
Contact: Yusuf Turan, MD 00902166254545 ext 8807 dryusufturan@gmail.com

Locations
Layout table for location information
Turkey
Marmara University Pendik Education and Research Hospital Recruiting
Istanbul, Turkey
Contact: Yusuf Turan, MD         
Sponsors and Collaborators
Marmara University
Investigators
Layout table for investigator information
Study Director: Haldun Akoglu, MD., Prof. Marmara University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:
Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basanez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabe E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fevre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gosselin R, Grainger R, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Ma J, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leon FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2163-96. doi: 10.1016/S0140-6736(12)61729-2. Erratum In: Lancet. 2013 Feb 23;381(9867):628. AlMazroa, Mohammad A [added]; Memish, Ziad A [added].

Layout table for additonal information
Responsible Party: Haldun Akoglu, Professor of Emergency Medicine, Marmara University
ClinicalTrials.gov Identifier: NCT04287140    
Other Study ID Numbers: 09.2019.497
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haldun Akoglu, Marmara University:
migraine
pain
normal saline
diclofenac
 emergency department
adult
acute attack
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache
Acute Pain
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations