Status:
WITHDRAWN
A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache
Lead Sponsor:
Corewell Health South
Collaborating Sponsors:
Michigan State University
Conditions:
Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 treatme...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03472872
Start Date
September 5 2017
End Date
June 14 2020
Last Update
November 29 2024
Active Locations (1)
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1
Lakeland Regional Healthcare
Saint Joseph, Michigan, United States, 49085