A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache
Withdrawn before enrolling · Phase 4
Conditions studied: Headache
In brief
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.
Key facts
- Study ID
- NCT03472872
- Run by
- Corewell Health South
- People needed
- 0
- Starts
- 2017-09-05
- Expected to finish
- 2020-06-14
- Last updated by the study team
- 2024-11-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Lakeland Regional Healthcare — Saint Joseph, Michigan, United States
Full record on ClinicalTrials.gov
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