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

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ClinicalTrials.gov Identifier: NCT03472872
Recruitment Status : Enrolling by invitation
First Posted : March 21, 2018
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
Michigan State University
Information provided by (Responsible Party):
Lakeland Health

Tracking Information
First Submitted Date  ICMJE February 26, 2018
First Posted Date  ICMJE March 21, 2018
Last Update Posted Date March 21, 2018
Actual Study Start Date  ICMJE September 5, 2017
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
Pain Improvement [ Time Frame: 60 minutes ]
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
  • pain score at 30 minutes [ Time Frame: 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)
  • pain score at 90 minutes [ Time Frame: 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)
  • need for rescue medication in the ED [ Time Frame: 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)
  • patient's desire to receive the same medication again [ Time Frame: 90 minutes ]
    prior to discharge the ED staff will ask the patient if they would like to receive the same medication again.
  • Need for rescue medication [ Time Frame: 90 minutes ]
    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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache
Official Title  ICMJE A Randomized Double-blind Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache
Brief 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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider)
Masking Description:
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).
Primary Purpose: Treatment
Condition  ICMJE Headache
Intervention  ICMJE
  • Drug: Ketorolac
    15mg ketorolac in 100mL 0.9% normal saline IVPB 1,000mg acetaminophen in a 100ml IVPB
    Other Name: Toradol
  • Drug: Acetaminophen
    1,000mg acetaminophen IVPB
    Other Name: Ofirmev
Study Arms  ICMJE
  • Experimental: 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
    Intervention: Drug: Ketorolac
  • Experimental: 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
    Intervention: Drug: Acetaminophen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: March 14, 2018)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03472872
Other Study ID Numbers  ICMJE MMMC#1569
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lakeland Health
Study Sponsor  ICMJE Lakeland Health
Collaborators  ICMJE Michigan State University
Investigators  ICMJE Not Provided
PRS Account Lakeland Health
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP