Clinical trial NCT03472872: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Headache
Keywords: acetaminophen
ketorolac
prochlorperazine
diphenhydramine
Lead sponsor: Spectrum Health - Lakeland
Sponsor class: OTHER
Collaborators: name: Michigan State University
First posted: 2018-03-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Pain Improvement
timeFrame: 60 minutes
Secondary outcomes:
measure: pain score at 30 minutes
timeFrame: 30 minutes
measure: pain score at 90 minutes
timeFrame: 90 minutes
measure: need for rescue medication in the ED
timeFrame: 90 minutes
measure: patient's desire to receive the same medication again
timeFrame: 90 minutes
measure: Need for rescue medication
timeFrame: 90 minutes
Other outcomes:
Locations:
city: Saint Joseph
country: United States
facility: Lakeland Regional Healthcare
state: Michigan
Study officials:
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