The CHECK Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine

NCT02657031 | Completed Phase 4 Results

• 1 other identifier: EM 2015.13
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares the efficacy of low dose Ketamine versus Compazine for the control of headache in patients presenting to the Emergency Department.

Conditions

Headache

Keywords

Headache, Migraine

Outcome Measures

Primary Outcomes (1)

• Headache Following Intervention

  Reduction in 100 mm Visual Analog Scale (VAS) Score. Positive values represent a reduction in headache severity. The maximum possible change in VAS score is 100 mm, representing the complete relief of a maximally severe headache. A change of 0 mm corresponds to no change in headache severity, and a negative value indicates worsening of the headache after the medication.

  0-60 minutes

Secondary Outcomes (4)

• Anxiety

  0-60 minutes

• Nausea

  0-60 minutes

• The Number of Participants Experiencing Vomiting

  0-60 minutes

• The Number of Patients Experiencing Restlessness

  0-60 minutes

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

This arm uses standard of care treatment of prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV plus Normal Sailine 500 cc bolus

Drug: Prochlorperazine; Drug: Diphenhydramine; Drug: Normal Saline

Study Arm

EXPERIMENTAL

This arm uses stud drug regime of Ketamine 0.3 mg/kg along with Ondansetron 4 mg IV plus Normal Saline 500 cc bolus.

Drug: Ketamine; Drug: Ondansetron; Drug: Normal Saline

Interventions

Prochlorperazine DRUG

prochlorperazine 10 mg IV

Also known as: Compazine

Control Arm

Ketamine DRUG

Ketamine 0.3 mg/kg IV

Also known as: Ketalar

Study Arm

Diphenhydramine DRUG

Diphenhydromine 25 mg IV

Also known as: Benadryl

Control Arm

Ondansetron DRUG

Ondansetron 4 mg IV

Also known as: Zofran

Study Arm

Normal Saline DRUG

Normal Saline 500 cc IV Bolus

Also known as: NS

Control Arm; Study Arm

Eligibility Criteria

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

You may qualify if:

• Age 18 to 65 years
• Temperature \< 100.4° F
• Diastolic Blood Pressure \<104 mm Hg
• Normal neurological exam and mormal mental status

You may not qualify if:

• Pregnant or breastfeeding.
• 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

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)

• 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.

  PMID: 18958996 RESULT

• 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.

  PMID: 23936605 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 18387702 RESULT

• 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.

  PMID: 25366551 RESULT

• Adams HA. [Mechanisms of action of ketamine]. Anaesthesiol Reanim. 1998;23(3):60-3. German.

  PMID: 9707750 RESULT

• 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.

  PMID: 24180163 RESULT

• 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.

  PMID: 12598264 RESULT

• 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.

  PMID: 21880111 RESULT

• 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.

  PMID: 14633551 RESULT

• 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.

  PMID: 24127709 RESULT

• 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.

  PMID: 25817884 RESULT

• 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.

  PMID: 17157685 RESULT

MeSH Terms

Conditions

Headache; Migraine Disorders

Interventions

Prochlorperazine; Ketamine; Diphenhydramine; Ondansetron; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Ethylamines; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Tony Zitek
• Organization: University Medical Center Emergency Department

zitek10@gmail.com

7022247124

Study Officials

• Joseph A Zitek, MD

  Unviersity of Nevada School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-Blind Randomized Clinical Control Trial

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 15, 2016
• Study Start: March 17, 2016
• Primary Completion: March 21, 2017
• Study Completion: March 21, 2017
• Last Updated: December 11, 2017
• Results First Posted: December 11, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)