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

Headache Clinical Trial

Official title:

The Check Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine. A Multi-Center, Randomized Double-Blind, Clinical Control Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657031
• Other study ID #: EM 2015.13
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2016
• Last updated: December 7, 2017
• Start date: March 17, 2016
• Est. completion date: March 21, 2017

Study information

• Verified date: December 2017
• Source: University Medical Center of Southern Nevada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

After enrollment, each patient will randomized either to the standard treatment arm to receive prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV, OR to the study arm to receive Ketamine 0.3 mg/kg along with ondansetron 4 mg IV. The diphenhydramine or ondansetron will be administered first, and immediately afterward the prochlorperazine or Ketamine will be administered. The prochlorperazine or Ketamine will be diluted in saline so that the total volume is 5 mL, and will be administered over 2 minutes. The diphenhydramine will be diluted in saline so that it is 2 mL (the same volume as the ondansetron). Both groups will also receive a 500 mL normal saline bolus after the study medications are administered. The ED pharmacist will be responsible for preparing the medications, using a double-blind protocol. He or she will record which arm the patient was randomized to. Only the pharmacist will have access to the randomization records and will not reveal the randomization until the end of the study. Emergency providers will be instructed not to administer any rescue medications for at least 30 minutes. The electronic medical record order will read "randomized study medication" (for the Ketamine or prochlorperazine) and "randomized add-on medication" (for the ondansetron or diphenhydramine).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 21, 2017
• Est. primary completion date: March 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18 to 65 years

• Temperature < 100.4° F

• Diastolic Blood Pressure <104 mm Hg

• Normal neurological exam and mormal mental status

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Headache

Intervention

Drug:
• 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

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 (21)

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

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. — 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. — 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. — View Citation

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. — 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 — 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 treatme — View Citation

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 E — View Citation

Gelfand AA, Goadsby PJ. A Neurologist's Guide to Acute Migraine Therapy in the Emergency Room. Neurohospitalist. 2012 Apr 1;2(2):51-59. — View Citation

Hocking G, Cousins MJ. Ketamine in chronic pain management: an evidence-based review. Anesth Analg. 2003 Dec;97(6):1730-9. Review. — 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/ — View Citation

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. — View Citation

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. Review. — 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. — View Citation

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. — View Citation

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 — View Citation

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. — 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. — View Citation

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):789-95, table of contents. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anxiety	Reduction in 100 mm Visual Analog Scale (VAS) Score. The maximum possible change in VAS score is 100 mm, representing the complete relief of maximum anxiety. A change of 0 mm corresponds to no change in anxiety level, and a negative value indicates worsening of the anxiety after the medication.	0-60 minutes
Secondary	Nausea	Reduction in 100 mm Visual Analog Scale (VAS) Score. The maximum possible change in VAS score is 100 mm, representing the complete relief of maximum nausea. A change of 0 mm corresponds to no change in nausea level, and a negative value indicates worsening of the nausea after the medication.	0-60 minutes
Secondary	The Number of Participants Experiencing Vomiting	Yes/No	0-60 minutes
Secondary	The Number of Patients Experiencing Restlessness	Yes/No	0-60 minutes