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

• Status: Unknown status
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lakeland Health; Spectrum Health - Lakeland
• Collaborator: Michigan State University
• Treatments: Acetaminophen; Diphenhydramine; Ketorolac; Ketorolac Tromethamine; Prochlorperazine; Promethazine

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