Intravenous Fluids in Benign Headaches Trial

NCT03185130 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2017-54
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Migraine headache has a 1-year period prevalence in the US of 11.7% and accounts for approximately 1.2 million migraine visits to US emergency departments per year . There are numerous studies that discuss treatment for migraine and other benign headaches within the emergency department (ED), however, there are very few that discuss specifically the use of intravenous fluids (IVF) for headache treatment. Many of these studies look at various options for treating migraine and other benign headaches: treatment options include dopamine antagonists, opioids, non-steroid anti-inflammatory drugs (NSAIDs), triptans, anti-epileptics and ergot derivatives. Comparisons have been done between many of these treatment options with dopamine antagonists appearing to be the most effective, compared to other treatments The dopamine antagonist with the most evidence and availability for benign headaches is prochlorperazine. Given that IVF administration is a common part of treatment regimen for benign headache patients in the emergency department and given the lack of randomized trials in adults, the investigators aim to study the use of IVF on pain reduction in headache patients in the adult ED. There has been one randomized trial in pediatrics that shows IVF may help in patients with migraines, whereas the adult literature has no randomized control trials and a review of data shows that fluids do not help relieve pain in migraine headache patients. This study will include both adult and pediatric patients presenting to the Emergency Department with complaint of benign headache.

Conditions

Headache

Keywords

Headache; Benign Headache

Outcome Measures

Primary Outcomes (1)

• Reduction in Pain Scores at 60 Minutes

  The primary outcome measure will be the mean reduction in pain scores at 60 min. In other words the pain score at time zero minus the pain score at time 60 minutes. Pain scores are measured 0-100, with 0 being no pain and 100 being maximal pain, on a visual analog scale score. Higher numbers indicate more pain reduction.

  60 minutes

Secondary Outcomes (6)

• Reduction in Pain Score at 30 Minutes

  30 minutes

• Admissions

  1 day

• Reduction in Nausea Score at 60 Minutes

  60 minutes

• Vomiting

  60 minutes

• Rescue Medication

  60 minutes

Study Arms (2)

Standard Treatment Arm

ACTIVE COMPARATOR

Standard Treatment Arm will receive: normal saline at 5 ml IV given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV.

Drug: Normal Saline 5mL; Drug: Prochlorperazine 0.15 mg/kg up to 10 mg IV; Drug: Diphenhydramine 1 mg/kg up to 50 mg IV

Study Arm

EXPERIMENTAL

Study arm patients will receive: normal saline at 20 mL/kg (up to 1000 mL) given over 1 hour, prochlorperazine 0.15 mg/kg up to 10 mg IV, diphenhydramine 1mg/kg (up to 50 mg) IV.

Drug: Normal Saline 20mL/kg; Drug: Prochlorperazine 0.15 mg/kg up to 10 mg IV; Drug: Diphenhydramine 1 mg/kg up to 50 mg IV

Interventions

Normal Saline 5mL DRUG

Control arm subjects will receive Normal Saline 5 mL IV over 1 hour

Also known as: NS, Saline

Standard Treatment Arm

Normal Saline 20mL/kg DRUG

Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour,

Also known as: NS, Saline

Study Arm

Prochlorperazine 0.15 mg/kg up to 10 mg IV DRUG

Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push

Also known as: Compazine

Standard Treatment Arm; Study Arm

Diphenhydramine 1 mg/kg up to 50 mg IV DRUG

Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push

Also known as: Benadryl

Standard Treatment Arm; Study Arm

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 10 to 65 years
• Temperature less than 100.4 F
• Normal neurologic exam and normal mental status

You may not qualify if:

• Pregnant
• Meningeal signs are present
• Acute angle closure glaucoma is suspected
• Head trauma within the previous two weeks
• Lumbar puncture within the previous two weeks
• Thunderclap onset of the headache
• Known allergy to one of the study drugs
• History of intracranial hypertension
• Is a prisoner
• Patient declined informed consent
• Non-English speaking patient or parent/guardian for pediatric patients
• Attending provider excludes patient
• Severe Dehydration

Sponsors & Collaborators

• University Medical Center of Southern Nevada: lead

Study Sites (1)

University medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Related Publications (21)

• Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9. doi: 10.1212/01.wnl.0000252808.97649.21.

  PMID: 17261680 BACKGROUND

• Friedman BW, West J, Vinson DR, Minen MT, Restivo A, Gallagher EJ. Current management of migraine in US emergency departments: an analysis of the National Hospital Ambulatory Medical Care Survey. Cephalalgia. 2015 Apr;35(4):301-9. doi: 10.1177/0333102414539055. Epub 2014 Jun 19.

  PMID: 24948146 BACKGROUND

• Balbin JE, Nerenberg R, Baratloo A, Friedman BW. Intravenous fluids for migraine: a post hoc analysis of clinical trial data. Am J Emerg Med. 2016 Apr;34(4):713-6. doi: 10.1016/j.ajem.2015.12.080. Epub 2015 Dec 30.

  PMID: 26825817 BACKGROUND

• Cicek M, Karcioglu O, Parlak I, Ozturk V, Duman O, Serinken M, Guryay M. Prospective, randomised, double blind, controlled comparison of metoclopramide and pethidine in the emergency treatment of acute primary vascular and tension type headache episodes. Emerg Med J. 2004 May;21(3):323-6. doi: 10.1136/emj.2002.000356.

  PMID: 15107371 BACKGROUND

• Friedman BW, Adewunmi V, Campbell C, Solorzano C, Esses D, Bijur PE, Gallagher EJ. A randomized trial of intravenous ketorolac versus intravenous metoclopramide plus diphenhydramine for tension-type and all nonmigraine, noncluster recurrent headaches. Ann Emerg Med. 2013 Oct;62(4):311-318.e4. doi: 10.1016/j.annemergmed.2013.03.017. Epub 2013 Apr 6.

  PMID: 23567060 BACKGROUND

• Kostic MA, Gutierrez FJ, Rieg TS, Moore TS, Gendron RT. A prospective, randomized trial of intravenous prochlorperazine versus subcutaneous sumatriptan in acute migraine therapy in the emergency department. Ann Emerg Med. 2010 Jul;56(1):1-6. doi: 10.1016/j.annemergmed.2009.11.020. Epub 2010 Jan 4.

  PMID: 20045576 BACKGROUND

• Tanen DA, Miller S, French T, Riffenburgh RH. Intravenous sodium valproate versus prochlorperazine for the emergency department treatment of acute migraine headaches: a prospective, randomized, double-blind trial. Ann Emerg Med. 2003 Jun;41(6):847-53. doi: 10.1067/mem.2003.195.

  PMID: 12764341 BACKGROUND

• Jones J, Sklar D, Dougherty J, White W. Randomized double-blind trial of intravenous prochlorperazine for the treatment of acute headache. JAMA. 1989 Feb 24;261(8):1174-6.

  PMID: 2915441 BACKGROUND

• Friedman BW, Esses D, Solorzano C, Dua N, Greenwald P, Radulescu R, Chang E, Hochberg M, Campbell C, Aghera A, Valentin T, Paternoster J, Bijur P, Lipton RB, Gallagher EJ. A randomized controlled trial of prochlorperazine versus metoclopramide for treatment of acute migraine. Ann Emerg Med. 2008 Oct;52(4):399-406. doi: 10.1016/j.annemergmed.2007.09.027. Epub 2007 Nov 19.

  PMID: 18006188 BACKGROUND

• Callan JE, Kostic MA, Bachrach EA, Rieg TS. Prochlorperazine vs. promethazine for headache treatment in the emergency department: a randomized controlled trial. J Emerg Med. 2008 Oct;35(3):247-53. doi: 10.1016/j.jemermed.2007.09.047. Epub 2008 Jun 5.

  PMID: 18534808 BACKGROUND

• Coppola M, Yealy DM, Leibold RA. Randomized, placebo-controlled evaluation of prochlorperazine versus metoclopramide for emergency department treatment of migraine headache. Ann Emerg Med. 1995 Nov;26(5):541-6. doi: 10.1016/s0196-0644(95)70001-3.

  PMID: 7486359 BACKGROUND

• Miner JR, Fish SJ, Smith SW, Biros MH. Droperidol vs. prochlorperazine for benign headaches in the emergency department. Acad Emerg Med. 2001 Sep;8(9):873-9. doi: 10.1111/j.1553-2712.2001.tb01147.x.

  PMID: 11535479 BACKGROUND

• Dychter SS, Gold DA, Carson D, Haller M. Intravenous therapy: a review of complications and economic considerations of peripheral access. J Infus Nurs. 2012 Mar-Apr;35(2):84-91. doi: 10.1097/NAN.0b013e31824237ce.

  PMID: 22382792 BACKGROUND

• Homer LD, Holmes KR. Risks associated with 72- and 96-hour peripheral intravenous catheter dwell times. J Intraven Nurs. 1998 Sep-Oct;21(5):301-5.

  PMID: 9814284 BACKGROUND

• Gentges J, Arthur A, Stamile T, Figureido M. Peripheral Intravenous Line Placement and Utilization in an Academic Emergency Department. J Emerg Med. 2016 Feb;50(2):235-8. doi: 10.1016/j.jemermed.2015.08.006.

  PMID: 26433429 BACKGROUND

• Myburgh JA. Fluid resuscitation in acute medicine: what is the current situation? J Intern Med. 2015 Jan;277(1):58-68. doi: 10.1111/joim.12326. Epub 2014 Nov 25.

  PMID: 25352314 BACKGROUND

• Tfelt-Hansen P, Pascual J, Ramadan N, Dahlof C, D'Amico D, Diener HC, Hansen JM, Lanteri-Minet M, Loder E, McCrory D, Plancade S, Schwedt T; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: third edition. A guide for investigators. Cephalalgia. 2012 Jan;32(1):6-38. doi: 10.1177/0333102411417901. No abstract available.

  PMID: 22384463 BACKGROUND

• Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available.

  PMID: 14979299 BACKGROUND

• Patniyot IR, Gelfand AA. Acute Treatment Therapies for Pediatric Migraine: A Qualitative Systematic Review. Headache. 2016 Jan;56(1):49-70. doi: 10.1111/head.12746.

  PMID: 26790849 BACKGROUND

• Richer L, Craig W, Rowe B. Randomized controlled trial of treatment expectation and intravenous fluid in pediatric migraine. Headache. 2014 Oct;54(9):1496-505. doi: 10.1111/head.12443. Epub 2014 Aug 28.

  PMID: 25168404 BACKGROUND

• Zitek T, Sigal T, Sun G, Martin Manuel C, Tran K. I-FiBH trial: intravenous fluids in benign headaches-a randomised, single-blinded clinical trial. Emerg Med J. 2020 Aug;37(8):469-473. doi: 10.1136/emermed-2019-209389. Epub 2020 Jul 3.

  PMID: 32620543 DERIVED

MeSH Terms

Conditions

Headache

Interventions

Saline Solution; Sodium Chloride; Prochlorperazine; Diphenhydramine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethylamines; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Tony Zitek, MD
• Organization: University Medical Center of Southern Nevada

zitek10@gmail.com

7023837885

Study Officials

• Tony Zitek, MD

  University Medical Center of Southern Nevada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: By necessity the subject will be blinded but the RN administering the IV fluids will need to know the rate of infusion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: This will be a single center, prospective, single blinded randomized controlled trial on a convenience sample of patients presenting to the adult or pediatric ED with a chief complaint of headache.

Study Record Dates

• First Submitted: June 10, 2017
• First Posted: June 14, 2017
• Study Start: May 16, 2017
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: June 6, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)