The CHECK Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine
NCT ID: NCT02657031
Last Updated: 2017-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
54 participants
INTERVENTIONAL
2016-03-17
2017-03-21
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control Arm
This arm uses standard of care treatment of prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV plus Normal Sailine 500 cc bolus
Prochlorperazine
prochlorperazine 10 mg IV
Diphenhydramine
Diphenhydromine 25 mg IV
Normal Saline
Normal Saline 500 cc IV Bolus
Study Arm
This arm uses stud drug regime of Ketamine 0.3 mg/kg along with Ondansetron 4 mg IV plus Normal Saline 500 cc bolus.
Ketamine
Ketamine 0.3 mg/kg IV
Ondansetron
Ondansetron 4 mg IV
Normal Saline
Normal Saline 500 cc IV Bolus
Interventions
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Prochlorperazine
prochlorperazine 10 mg IV
Ketamine
Ketamine 0.3 mg/kg IV
Diphenhydramine
Diphenhydromine 25 mg IV
Ondansetron
Ondansetron 4 mg IV
Normal Saline
Normal Saline 500 cc IV Bolus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Temperature \< 100.4° F
* Diastolic Blood Pressure \<104 mm Hg
* Normal neurological exam and mormal mental status
Exclusion Criteria
* 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
* Weight more than 150 kg or less than 40 kg.
* Known allergy to one of the study drugs.
* History of schizophrenia or bipolar disorder.
* History of intracranial hypertension.
* Is a prisoner
* Patient declined informed consent
* Non-English speaking patient.
* Attending provider excludes patient
18 Years
65 Years
ALL
No
Sponsors
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University Medical Center of Southern Nevada
OTHER
Responsible Party
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Principal Investigators
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Joseph A Zitek, MD
Role: PRINCIPAL_INVESTIGATOR
Unviersity of Nevada School of Medicine
Locations
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University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Countries
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References
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Pitts SR, Niska RW, Xu J, Burt CW. National Hospital Ambulatory Medical Care Survey: 2006 emergency department summary. Natl Health Stat Report. 2008 Aug 6;(7):1-38.
Gelfand AA, Goadsby PJ. A Neurologist's Guide to Acute Migraine Therapy in the Emergency Room. Neurohospitalist. 2012 Apr 1;2(2):51-59. doi: 10.1177/1941874412439583.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Friedman BW, Hochberg ML, Esses D, Grosberg BM, Rothberg D, Bernstein B, Bijur PE, Lipton RB, Gallagher EJ. Recurrence of primary headache disorders after emergency department discharge: frequency and predictors of poor pain and functional outcomes. Ann Emerg Med. 2008 Dec;52(6):696-704. doi: 10.1016/j.annemergmed.2008.01.334. Epub 2008 Apr 3.
McCarthy LH, Cowan RP. Comparison of parenteral treatments of acute primary headache in a large academic emergency department cohort. Cephalalgia. 2015 Aug;35(9):807-15. doi: 10.1177/0333102414557703. Epub 2014 Nov 3.
Adams HA. [Mechanisms of action of ketamine]. Anaesthesiol Reanim. 1998;23(3):60-3. German.
Eghbal MH, Taregh S, Amin A, Sahmeddini MA. Ketamine improves postoperative pain and emergence agitation following adenotonsillectomy in children. A randomized clinical trial. Middle East J Anaesthesiol. 2013 Jun;22(2):155-60.
Weinbroum AA. A single small dose of postoperative ketamine provides rapid and sustained improvement in morphine analgesia in the presence of morphine-resistant pain. Anesth Analg. 2003 Mar;96(3):789-795. doi: 10.1213/01.ANE.0000048088.17761.B4.
McGuinness SK, Wasiak J, Cleland H, Symons J, Hogan L, Hucker T, Mahar PD. A systematic review of ketamine as an analgesic agent in adult burn injuries. Pain Med. 2011 Oct;12(10):1551-8. doi: 10.1111/j.1526-4637.2011.01220.x. Epub 2011 Aug 31.
Hocking G, Cousins MJ. Ketamine in chronic pain management: an evidence-based review. Anesth Analg. 2003 Dec;97(6):1730-1739. doi: 10.1213/01.ANE.0000086618.28845.9B.
Andolfatto G, Willman E, Joo D, Miller P, Wong WB, Koehn M, Dobson R, Angus E, Moadebi S. Intranasal ketamine for analgesia in the emergency department: a prospective observational series. Acad Emerg Med. 2013 Oct;20(10):1050-4. doi: 10.1111/acem.12229.
Motov S, Rockoff B, Cohen V, Pushkar I, Likourezos A, McKay C, Soleyman-Zomalan E, Homel P, Terentiev V, Fromm C. Intravenous Subdissociative-Dose Ketamine Versus Morphine for Analgesia in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2015 Sep;66(3):222-229.e1. doi: 10.1016/j.annemergmed.2015.03.004. Epub 2015 Mar 26.
Miner JR, Smith SW, Moore J, Biros M. Sumatriptan for the treatment of undifferentiated primary headaches in the ED. Am J Emerg Med. 2007 Jan;25(1):60-4. doi: 10.1016/j.ajem.2006.06.004.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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EM 2015.13
Identifier Type: -
Identifier Source: org_study_id