Back to resultsA Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache
Primary Purpose
Headache
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Acetaminophen
Sponsored by
About this trial
This is an interventional treatment trial for Headache focused on measuring acetaminophen, ketorolac, prochlorperazine, diphenhydramine
Eligibility 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
Sites / Locations
- Lakeland Regional Healthcare
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ketorolac Arm
Acetaminophen Arm
Arm Description
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
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
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
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)
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.
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)
Full Information
NCT ID
NCT03472872
First Posted
February 26, 2018
Last Updated
October 27, 2022
Sponsor
Spectrum Health - Lakeland
Collaborators
Michigan State University
1. Study Identification
Unique Protocol Identification Number
NCT03472872
Brief Title
A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache
Official Title
A Randomized Double-blind Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
no longer recruiting or studying
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
June 14, 2020 (Actual)
Study Completion Date
June 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Health - Lakeland
Collaborators
Michigan State University
4. Oversight
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
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
acetaminophen, ketorolac, prochlorperazine, diphenhydramine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare 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).
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketorolac Arm
Arm Type
Experimental
Arm Description
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
Arm Title
Acetaminophen Arm
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
15mg ketorolac in 100mL 0.9% normal saline IVPB 1,000mg acetaminophen in a 100ml IVPB
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Ofirmev
Intervention Description
1,000mg acetaminophen IVPB
Primary Outcome Measure Information:
Title
Pain Improvement
Description
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)
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
pain score at 30 minutes
Description
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)
Time Frame
30 minutes
Title
pain score at 90 minutes
Description
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)
Time Frame
90 minutes
Title
need for rescue medication in the ED
Description
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)
Time Frame
90 minutes
Title
patient's desire to receive the same medication again
Description
prior to discharge the ED staff will ask the patient if they would like to receive the same medication again.
Time Frame
90 minutes
Title
Need for rescue medication
Description
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)
Time Frame
90 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Lakeland Regional Healthcare
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
http://ofirmev.com/Safety/
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Learn more about this trial
A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache
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