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

NCT03472872 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: MMMC#1569
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache

Keywords

acetaminophen; ketorolac; prochlorperazine; diphenhydramine

Outcome Measures

Primary Outcomes (1)

• 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)

  60 minutes

Secondary Outcomes (5)

• pain score at 30 minutes

  30 minutes

• pain score at 90 minutes

  90 minutes

• need for rescue medication in the ED

  90 minutes

• patient's desire to receive the same medication again

  90 minutes

• Need for rescue medication

  90 minutes

Study Arms (2)

Ketorolac Arm

EXPERIMENTAL

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

Drug: Ketorolac

Acetaminophen Arm

EXPERIMENTAL

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

Drug: Acetaminophen

Interventions

Ketorolac DRUG

15mg ketorolac in 100mL 0.9% normal saline IVPB 1,000mg acetaminophen in a 100ml IVPB

Also known as: Toradol

Ketorolac Arm

Acetaminophen DRUG

1,000mg acetaminophen IVPB

Also known as: Ofirmev

Acetaminophen Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Corewell Health South: lead
• Michigan State University: collaborator

Study Sites (1)

Lakeland Regional Healthcare

Saint Joseph, Michigan, 49085, United States

Location

Related Publications (21)

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• Lipton RB, Baggish JS, Stewart WF, Codispoti JR, Fu M. Efficacy and safety of acetaminophen in the treatment of migraine: results of a randomized, double-blind, placebo-controlled, population-based study. Arch Intern Med. 2000 Dec 11-25;160(22):3486-92. doi: 10.1001/archinte.160.22.3486.

  PMID: 11112243 BACKGROUND

• Lucado J, Paez K, Elixhauser A. Headaches in U.S. Hospitals and Emergency Departments, 2008. 2011 May. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #111. Available from http://www.ncbi.nlm.nih.gov/books/NBK56047/

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• Shrestha M, Singh R, Moreden J, Hayes JE. Ketorolac vs chlorpromazine in the treatment of acute migraine without aura. A prospective, randomized, double-blind trial. Arch Intern Med. 1996 Aug 12-26;156(15):1725-8.

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MeSH Terms

Conditions

Headache

Interventions

Ketorolac; Ketorolac Tromethamine; Acetaminophen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind trial comparing two parenteral adjuvant treatments for headache among patients presenting to the Lakeland Health Emergency Department in St. Joseph, MI.

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 21, 2018
• Study Start: September 5, 2017
• Primary Completion: June 14, 2020
• Study Completion: June 14, 2020
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)