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Trial record 49 of 1877 for:    Acetaminophen

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):
Spectrum Health - Lakeland

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.

Condition or disease Intervention/treatment Phase
Headache Drug: Ketorolac Drug: Acetaminophen Phase 4

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
Official Title: A Randomized Double-blind Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
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
Drug: Ketorolac
15mg ketorolac in 100mL 0.9% normal saline IVPB 1,000mg acetaminophen in a 100ml IVPB
Other Name: Toradol

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
Drug: Acetaminophen
1,000mg acetaminophen IVPB
Other Name: Ofirmev




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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.

  5. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472872


Locations
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United States, Michigan
Lakeland Regional Healthcare
Saint Joseph, Michigan, United States, 49085
Sponsors and Collaborators
Spectrum Health - Lakeland
Michigan State University

Additional Information:
Publications:

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Responsible Party: Spectrum Health - Lakeland
ClinicalTrials.gov Identifier: NCT03472872     History of Changes
Other Study ID Numbers: MMMC#1569
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Spectrum Health - Lakeland:
acetaminophen
ketorolac
prochlorperazine
diphenhydramine
Additional relevant MeSH terms:
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Acetaminophen
Emergencies
Headache
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Diphenhydramine
Promethazine
Ketorolac
Ketorolac Tromethamine
Prochlorperazine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Local
Anesthetics