Intravenous Fluids in Benign Headaches Trial: A Randomized Single Blind Clinical Trial
| Registry | NCT03185130, acronym I-FiBH |
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| Status | Completed |
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| Phase | Phase 4 |
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| Study type | Interventional; randomized, parallel, masking: single, treatment |
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| Enrollment | 58 (Actual) |
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| Sponsor | University Medical Center of Southern Nevada (Other) |
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| Conditions | Headache |
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| Interventions | Normal Saline 5mL, Normal Saline 20mL/kg, Prochlorperazine 0.15 mg/kg up to 10 mg IV, Diphenhydramine 1 mg/kg up to 50 mg IV (Drug) |
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| Dates | start 2017-05-16, primary completion 2019-05-15, completion 2019-05-15, first posted 2017-06-14, last updated 2024-06-06 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Headache All trials of Normal Saline 5mL All trials of Normal Saline 20mL/kg
-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.
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+Detailed 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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Standard Treatment Arm | Active comparator | 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 | 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. |
| Study Arm | Experimental | 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 | 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. |
- Normal Saline 5mL (Drug), also known as NS, Saline: Control arm subjects will receive Normal Saline 5 mL IV over 1 hour
- Normal Saline 20mL/kg (Drug), also known as NS, Saline: 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 (Drug), also known as Compazine: 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 (Drug), also known as Benadryl: Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
+Outcome measures
Primary outcomes
- Reduction in Pain Scores at 60 Minutes [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.
Secondary outcomes
- Reduction in Pain Score at 30 Minutes [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.
- Admissions [1 day]: The difference between the rates of admission will be measured.
- Reduction in Nausea Score at 60 Minutes [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.
- Vomiting [60 minutes]: The difference in the percentage of patients in each group who vomit within one hour after the treatment starts.
- Rescue Medication [60 minutes]: 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.
- Percentage of Patients With Persistent Headache [24-48 hours after discharge.]: The difference between the rates of persistent headache with telephone follow up.
+Eligibility
Sex: All, ages: 10 Years to 65 Years
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
+Posted results
Participant flow
| Milestone | Standard Treatment Arm | Study Arm |
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| Started | 23 | 35 |
| Completed | 23 | 33 |
| Not completed | 0 | 2 |
Outcome results
- Reduction in Pain Scores at 60 Minutes (Primary), Mean, reduction in visual analog pain score: Standard Treatment Arm 48.7 +/- 29.3; Study Arm 48.3 +/- 31.0
- Reduction in Pain Score at 30 Minutes (Secondary), Mean, change in pain score: Standard Treatment Arm 34.8 +/- 29.6; Study Arm 31.8 +/- 27.1
- Admissions (Secondary), Count of participants, Participants: Standard Treatment Arm 0; Study Arm 2
- Reduction in Nausea Score at 60 Minutes (Secondary), Mean, reduction in nausea score: Standard Treatment Arm 31.8 +/- 33.4; Study Arm 25.2 +/- 34.2
- Vomiting (Secondary), Count of participants, Participants: Standard Treatment Arm 0; Study Arm 0
- Rescue Medication (Secondary), Count of participants, Participants: Standard Treatment Arm 3; Study Arm 7
- Percentage of Patients With Persistent Headache (Secondary), Count of participants, Participants: Standard Treatment Arm 4; Study Arm 11
Adverse events
Time frame: 48 hours
| Arm | Deaths | Serious adverse events | Other adverse events |
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| Standard Treatment Arm | 0/23 (0.0%) | 0/23 (0.0%) | 0/23 (0.0%) |
| Study Arm | 0/35 (0.0%) | 0/35 (0.0%) | 0/35 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
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| University medical Center of Southern Nevada | Las Vegas, Nevada | United States | |
+Publications
- 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
- 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
- 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
- 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
- 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
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- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Results publication: 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
+Study documents
+Investigators
- Tony Zitek, MD, Principal investigator, University Medical Center of Southern Nevada