Ketamine and Morphine Versus Morphine Alone for the Treatment of Acute Pain in the Emergency Department

Our goal is to study whether giving people low dose ketamine along with morphine when they come to the Emergency Department will help their pain more than giving morphine by itself. There have been many studies showing that low dose ketamine is safe and effective for pain control. Ketamine is frequently used for pain control in ambulances and helicopters transporting injured patients to the hospital and has also been used for pain control in people who have just had surgery. The investigators would like to see if low dose ketamine would be safe and effective for patients with pain in the Emergency Department.

Patients are eligible for the study if they come to the Emergency Department and their treating physician decides to treat them with morphine (with certain exceptions such as pregnant patients and patients with eye injuries). They will be given information about participating in the study and if they agree, they will be given the study drug. The study drug will be either ketamine or salt water (saline). If patients continue to be in pain they will continue to receive doses of morphine just as they would if they were not in the study. If the treating physician feels that morphine alone is not enough, they will be free to choose another pain medication as they would normally.

Study Overview

• Status: Terminated
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Morphine; Drug: placebo; Drug: Ketamine

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Berkman, MD; Phone Number: (520) 626-5510; Email: mberkman@aemrc.arizona.edu

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Health Network University Campus 1501 North Campbell Ave

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Presenting to Emergency Department in acute pain
• age 18 and over
• determined to require morphine for pain control by treating physician

Exclusion Criteria:

• Patients presenting with headache or head injury
• Patient with eye injury or eye pain
• Nontraumatic chest Pain
• Pregnant patients or women of childbearing potential
• Patients allergic to morphine or ketamine
• Patients with known history of narcotic/alcohol abuse or presenting for narcotic medication refill
• Patients with hypertension: diastolic blood pressure > 100 OR systolic blood pressure > 180
• Patient whose pain is so severe that they are unable to give informed consent
• Patients who have had bad experiences to prior hallucinations from any origin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Morphine and placebo; Patient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy	Drug: Morphine; Dosage of morphine determined by treating physician; Drug: placebo; saline of same volume as appropriate weight based dose of ketamine
Experimental: Morphine and Ketamine; Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care	Drug: Morphine; Dosage of morphine determined by treating physician; Drug: Ketamine; 0.3mg/kg ketamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Score	Pain 0-10 with 0 being no pain and 10 being the worst pain	Baseline (zero minutes), 30 minutes and 1 hour after receiving study drug

Secondary Outcome Measures

Outcome Measure	Time Frame
Total Amount of Morphine and Other Pain Medications Administered	Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours)
Number of Participants With Adverse Events	Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours)

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: Arizona College of Emergency Physicians

Publications and helpful links

General Publications

• Berkman, M. R., Larsen, J., Smith, J., Caldwell, J., Waterbrook, A., Stolz, U., & Denninghoff, K. (2014). 369 Ketamine and Morphine versus Morphine Alone for Treatment of Acute Pain in the Emergency Department. Annals of Emergency Medicine, 64(4), S131-S132.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (Estimated): July 17, 2013

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Ketamine; Acute Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Acute Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Ketamine; Morphine
• Other Study ID Numbers: 13-0045