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HeadachePhase 4NCT03472872

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

A Phase 4 study testing Ketorolac and Acetaminophen in people with Headache, run by Corewell Health South at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Headache
What is being tested?
Ketorolac and Acetaminophen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
5 Sep 2017to 14 Jun 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 to 65 years
  • 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)

Who cannot join

  • Age < 18 years or > 65 years
  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lakeland Regional Healthcare

    Saint Joseph, Michigan, 49085

Other trials in United States

About this study

Official title: A Randomized Double-blind Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache

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.

Read the detailed description

After initial assessment of the patient by the provider, including careful review of inclusion and exclusion criteria, informed consent will be obtained. If a patient does not wish to participate in this study, he/she will receive alternative treatment at the discretion of their ED provider.

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
Headache
Keywords
acetaminophen, ketorolac, prochlorperazine, diphenhydramine
Medical subject headings
Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetorolacDrug

    Also called Toradol

    15mg ketorolac in 100mL 0.9% normal saline IVPB 1,000mg acetaminophen in a 100ml IVPB

  • AcetaminophenDrug

    Also called Ofirmev

    1,000mg acetaminophen IVPB

Study groups in NCT03472872
Study groupRoleWhat they receive
Ketorolac ArmExperimentalThe 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
Receives: Drug: Ketorolac
Acetaminophen ArmExperimentalThe 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
Receives: Drug: Acetaminophen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Improvement

    Comparison of the improvement in pain score between baseline and 60 minutes following analgesic administration, assessed using a Numeric Pain Rating Scale ( RATE PAIN FROM 0-10, with 0 = no pain and 10 = worst possible pain)

    Measured: 60 minutes

Secondary outcomes (5)

  1. pain score at 30 minutes

    ED staff will re-assess the patient and record level of pain at time of study drug administration and at 30 minutes after study drug administration, pain assessed using a Numeric Pain Rating Scale ( RATE PAIN FROM 0-10, with 0 = no pain and 10 = worst possible pain)

    Measured: 30 minutes

  2. pain score at 90 minutes

    ED staff will re-assess the patient and record level of pain at time of study drug administration and at 90 minutes after study drug administration, pain assessed using a Numeric Pain Rating Scale ( RATE PAIN FROM 0-10, with 0 = no pain and 10 = worst possible pain)

    Measured: 90 minutes

  3. need for rescue medication in the ED

    ED staff will re-assess the patient and record level of pain at time of study drug administration and at 90 minutes after study drug administration, pain assessed using a Numeric Pain Rating Scale ( RATE PAIN FROM 0-10, with 0 = no pain and 10 = worst possible pain)

    Measured: 90 minutes

  4. patient's desire to receive the same medication again

    prior to discharge the ED staff will ask the patient if they would like to receive the same medication again.

    Measured: 90 minutes

  5. Need for rescue medication

    If a rescue medication is required, the time, pain level, and type of medication given will be recorded. pain assessed using a Numeric Pain Rating Scale ( RATE PAIN FROM 0-10, with 0 = no pain and 10 = worst possible pain)

    Measured: 90 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2018
  2. Study start5 Sep 2017
  3. Primary completion14 Jun 2020
  4. Study completion14 Jun 2020

Why it stopped: no longer recruiting or studying

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind trial comparing two parenteral adjuvant treatments for headache among patients presenting to the Lakeland Health Emergency Department in St. Joseph, MI.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03472872
Sponsor's protocol ID
MMMC#1569
Status last verified
Nov 2024
First submitted
26 Feb 2018
Last updated
29 Nov 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25600719

  • 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.

    PubMed 23633349

  • 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.

    PubMed 25944813

  • 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.

    PubMed 27623005

  • 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.

    PubMed 26320523

  • 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.

    PubMed 23567060

  • 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.

    PubMed 18006188

  • 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.

    PubMed 24948146

  • 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.

    PubMed 2915441

  • 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.

    PubMed 11112243

  • 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/

    PubMed 21735579

  • 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.

    PubMed 1114616

  • 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.

    PubMed 25197573

  • 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.

    PubMed 23814378

  • 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.

    PubMed 27300483

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketorolac and Acetaminophen in people with Headache, run by Corewell Health South at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Improvement (time frame: 60 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03472872, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.

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