A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache

Summary

This randomized, double-blind trial will compare the clinical efficacy of IV acetaminophen to that of IV ketorolac as adjuncts to standard therapy (prochlorperazine and diphenhydramine) in the treatment of patients presenting to the emergency department with chief complaint of "headache" or variants thereof.

Timeline

Start

2017-09-05

Primary completion

2020-06-14

Completion

2020-06-14

Publications

• Background Burch RC, Loder S, Loder E, Smitherman TA. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. Headache. 2015 Jan;55(1):21-34. doi: 10.1111/head.12482.
• Background Derry S, Moore RA. Paracetamol (acetaminophen) with or without an antiemetic for acute migraine headaches in adults. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD008040. doi: 10.1002/14651858.CD008040.pub3.
• Background Gungor F, Akyol KC, Kesapli M, Celik A, Karaca A, Bozdemir MN, Eken C. Intravenous dexketoprofen vs placebo for migraine attack in the emergency department: A randomized, placebo-controlled trial. Cephalalgia. 2016 Feb;36(2):179-84. doi: 10.1177/0333102415584604. Epub 2015 May 5.
• Background Florence CS, Zhou C, Luo F, Xu L. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. Med Care. 2016 Oct;54(10):901-6. doi: 10.1097/MLR.0000000000000625.
• Background Friedman BW, Cabral L, Adewunmi V, Solorzano C, Esses D, Bijur PE, Gallagher EJ. Diphenhydramine as Adjuvant Therapy for Acute Migraine: An Emergency Department-Based Randomized Clinical Trial. Ann Emerg Med. 2016 Jan;67(1):32-39.e3. doi: 10.1016/j.annemergmed.2015.07.495. Epub 2015 Aug 29.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background Lipton RB, Baggish JS, Stewart WF, Codispoti JR, Fu M. Efficacy and safety of acetaminophen in the treatment of migraine: results of a randomized, double-blind, placebo-controlled, population-based study. Arch Intern Med. 2000 Dec 11-25;160(22):3486-92. doi: 10.1001/archinte.160.22.3486.
• Background Lucado J, Paez K, Elixhauser A. Headaches in U.S. Hospitals and Emergency Departments, 2008. 2011 May. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #111. Available from http://www.ncbi.nlm.nih.gov/books/NBK56047/
• Background Bukharin OV, Tolstov IuP, Anikin IA. [Indices of natural nonspecific immunity in chronic tonsillitis]. Vestn Otorinolaringol. 1975 Jan-Feb;(1):61-4. No abstract available. Russian.
• Background Masoumi K, Forouzan A, Asgari Darian A, Feli M, Barzegari H, Khavanin A. Comparison of clinical efficacy of intravenous acetaminophen with intravenous morphine in acute renal colic: a randomized, double-blind, controlled trial. Emerg Med Int. 2014;2014:571326. doi: 10.1155/2014/571326. Epub 2014 Aug 13.
• Background Needleman SM. Safety of rapid intravenous of infusion acetaminophen. Proc (Bayl Univ Med Cent). 2013 Jul;26(3):235-8. doi: 10.1080/08998280.2013.11928969.
• Background Orr SL, Friedman BW, Christie S, Minen MT, Bamford C, Kelley NE, Tepper D. Management of Adults With Acute Migraine in the Emergency Department: The American Headache Society Evidence Assessment of Parenteral Pharmacotherapies. Headache. 2016 Jun;56(6):911-40. doi: 10.1111/head.12835.
• Background Pardutz A, Schoenen J. NSAIDs in the Acute Treatment of Migraine: A Review of Clinical and Experimental Data. Pharmaceuticals (Basel). 2010 Jun 17;3(6):1966-1987. doi: 10.3390/ph3061966.
• Background Shrestha M, Singh R, Moreden J, Hayes JE. Ketorolac vs chlorpromazine in the treatment of acute migraine without aura. A prospective, randomized, double-blind trial. Arch Intern Med. 1996 Aug 12-26;156(15):1725-8.
• Background Taggart E, Doran S, Kokotillo A, Campbell S, Villa-Roel C, Rowe BH. Ketorolac in the treatment of acute migraine: a systematic review. Headache. 2013 Feb;53(2):277-87. doi: 10.1111/head.12009. Epub 2013 Jan 8.
• Background Turkcuer I, Serinken M, Eken C, Yilmaz A, Akdag O, Uyan E, Kiray C, Elicabuk H. Intravenous paracetamol versus dexketoprofen in acute migraine attack in the emergency department: a randomised clinical trial. Emerg Med J. 2014 Mar;31(3):182-5. doi: 10.1136/emermed-2013-203044. Epub 2014 Jan 6.
• Background Vinson DR, Drotts DL. Diphenhydramine for the prevention of akathisia induced by prochlorperazine: a randomized, controlled trial. Ann Emerg Med. 2001 Feb;37(2):125-31. doi: 10.1067/mem.2001.113032.
• Background Vinson DR, Hurtado TR, Vandenberg JT, Banwart L. Variations among emergency departments in the treatment of benign headache. Ann Emerg Med. 2003 Jan;41(1):90-7. doi: 10.1067/mem.2003.24.

Drugs

Indications