Intravenous Fluids in Benign Headaches Trial

Headache Clinical Trial

— I-FiBH  

Official title:

Intravenous Fluids in Benign Headaches Trial: A Randomized Single Blind Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185130
• Other study ID #: 2017-54
• Status: Completed
• Phase: Phase 4
• Start date: May 16, 2017
• Est. completion date: May 15, 2019

Study information

• Verified date: May 2024
• Source: University Medical Center of Southern Nevada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. Subjects will only be enrolled when a physician or research assistant who is familiar with the study protocol is available to enroll patients. Written, informed consent will be obtained from each patient. Consent will include a discussion of the risks and benefits. In addition to parental informed consent in the pediatric population, age appropriate verbal assent will be obtained from pediatric subjects. After 30 minutes, the treating provider will be permitted to administer a "rescue medication" of their choice for further treatment. If there is an untoward event that requires the patient to know which IVF dose was administered, patient will unblinded and will not continue in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 10 to 65 years

2. Temperature less than 100.4 F

3. Normal neurologic exam and normal mental status

Exclusion Criteria:

1. Pregnant

2. Meningeal signs are present

3. Acute angle closure glaucoma is suspected

4. Head trauma within the previous two weeks

5. Lumbar puncture within the previous two weeks

6. Thunderclap onset of the headache

7. Known allergy to one of the study drugs

8. History of intracranial hypertension

9. Is a prisoner

10. Patient declined informed consent

11. Non-English speaking patient or parent/guardian for pediatric patients

12. Attending provider excludes patient

13. Severe Dehydration

Related Conditions & MeSH terms

• Headache

Intervention

Drug:
• Normal Saline 5mL
Control arm subjects will receive Normal Saline 5 mL IV over 1 hour
• Normal Saline 20mL/kg
Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour,
• Prochlorperazine 0.15 mg/kg up to 10 mg IV
Standard Treatment Arm and Study Arm will receive prochlorperazine 0.15 mg/kg up to 10mg IV slow push
• Diphenhydramine 1 mg/kg up to 50 mg IV
Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push

Locations

Country	Name	City	State
United States	University medical Center of Southern Nevada	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center of Southern Nevada

Country where clinical trial is conducted

United States, 

References & Publications (20)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction in Pain Score at 30 Minutes	The mean reduction in pain scores at 30 minutes. This is calculated as the pain score at time zero minus the pain score at time 30 minutes. Pain scores are measured 0-100 on a visual analog scale score, with 0 being no pain and 100 being maximal pain. Higher numbers indicate more pain reduction.	30 minutes
Secondary	Admissions	The difference between the rates of admission will be measured.	1 day
Secondary	Reduction in Nausea Score at 60 Minutes	The reduction in mean nausea scores will be measured. This is calculated as the nausea score at time zero minus the nausea score at time 60 minutes. Nausea is measured from 0-100 on a visual analog scale with 0 being no nausea and 100 being maximal nausea. Higher numbers indicate more reduction in nausea.	60 minutes
Secondary	Vomiting	The difference in the percentage of patients in each group who vomit within one hour after the treatment starts.	60 minutes
Secondary	Rescue Medication	The difference between the percentage of patients requiring rescue medications for headache will be measured. "Rescue medications" are defined as any medication administered to the patient in the emergency department for their headache after the initial medications.	60 minutes
Secondary	Percentage of Patients With Persistent Headache	The difference between the rates of persistent headache with telephone follow up.	24-48 hours after discharge.