A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache
NCT ID: NCT03472872
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE4
INTERVENTIONAL
2017-09-05
2020-06-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The provider will place orders in the electronic medical record for "Headache study order set". This order set includes Compazine® 10 mg IV, Benadryl® 25 mg IV, and "study drug". Pharmacy will receive the order for the study drug. The research pharmacist will randomly assign participants to group A (1000 mg Ofirmev®) or group B (15 mg ketorolac). He/she will fill medication vials and IV bags in each "study kit". The kit for group A will contain a 100mL bag containing 1000 mg acetaminophen and a placebo vial of normal saline as well as both Compazine® and Benadryl®. The kit for group B will contain 100mL 0.9% normal saline and a vial containing 15 mg ketorolac as well as Compazine® and Benadryl®. The "study kit" will be sent to the emergency department via the tube system. When the study kit arrives, he/she will give each patient Compazine® and Benadryl®, hang the IV bag, and administer the contents of the vial. Therefore, every patient will receive a "push" of the contents in the vial (ketorolac or normal saline) and an 100mL infusion (Ofirmev or normal saline).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ketorolac Arm
The patient will receive a 0.9% normal saline bolus of 1,000ml at 500ml/hr, 25mg diphenhydramine IV, 10mg prochlorperazine IV, 15mg ketorolac in 100mL 0.9% normal saline IVPB
Ketorolac
15mg ketorolac in 100mL 0.9% normal saline IVPB 1,000mg acetaminophen in a 100ml IVPB
Acetaminophen Arm
The patient will receive a 0.9% normal saline bolus of 1,000ml at 500ml/hr, 25mg diphenhydramine IV, 10mg prochlorperazine IV, 1,000mg acetaminophen in a 100ml IVPB
Acetaminophen
1,000mg acetaminophen IVPB
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ketorolac
15mg ketorolac in 100mL 0.9% normal saline IVPB 1,000mg acetaminophen in a 100ml IVPB
Acetaminophen
1,000mg acetaminophen IVPB
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Presenting chief complaint of headache, migraine, tension headache, cluster headache, or headache not otherwise specified
* Report of pain 4 using a standard 11-point numerical scale (0 to 10; 0=no pain and 10=worst possible pain)
Exclusion Criteria
* Inability to provide informed consent
* Physical or mental disability hindering adequate response to assessment of pain
* Hemodynamic instability/medical condition requiring acute life-saving medical intervention
* Documented or suspected pregnancy or currently breastfeeding
* Known brain mass, intracranial hemorrhage, skull fracture
* Known allergy, hypersensitivity, or prior adverse reaction to acetaminophen, NSAIDs, diphenhydramine, or prochlorperazine
* Known contraindications to acetaminophen use
* Severe hepatic impairment, severe active liver disease
* Known contraindications to ketorolac/NSAID use
* Active bleeding, peptic ulcer disease, bleeding dyscrasias
* Known contraindication to diphenhydramine use
* Known contraindication to prochlorperazine use
* Comatose states or in the presence of large amounts of CNS depressants
* Patients who have consumed
* \> 2600 mg acetaminophen within the past 24 hours
* \> 500 mg acetaminophen within the previous 4 hours
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Michigan State University
OTHER
Spectrum Health - Lakeland
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lakeland Regional Healthcare
Saint Joseph, Michigan, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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/
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MMMC#1569
Identifier Type: -
Identifier Source: org_study_id