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Comparing Ketamine and Morphine in the Treatment of Acute Fracture Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02430818
Recruitment Status : Terminated (were not able to enroll patients to a satisfactory level)
First Posted : April 30, 2015
Results First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
MOCEP
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Opioid pain medications such as morphine and dilaudid are commonly used in emergency departments to treat pain in patients. Physicians are familiar with the side effects of these medications; the most concerning of which is slowing or stopping a patient's breathing, as well as dangerously lowering their blood pressure. An alternative medication is ketamine. This medication is also commonly used in the emergency department, although it is typically used to help sedate patients for uncomfortable procedures. Ketamine has also been used for pain control, but in a much lower dosage that does not sedate patients. When used for analgesia, it has typically been administered in combination with opioid pain medications. To date, there is no study that looks at the effectiveness and safety of using a low dose ketamine alone in comparison to the use of morphine. The purpose of this study is to measure how well low-dose ketamine treats pain compared to morphine and to look at how often serious side effects are seen with each medication.

Condition or disease Intervention/treatment Phase
Acute Pain Fractures Drug: ketamine Drug: morphine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing the Effectiveness of Low-dose Ketamine With Morphine to Treat Pain in Patients With Long Bone Fractures
Study Start Date : April 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Ketamine
Ketamine is a dissociative agent that is thought to modulate pain by binding to NMDA receptors. Participants assigned to the ketamine arm will be given 0.4 mg/kg IV of ketamine (40 mg maximum).
Drug: ketamine
Experimental: Morphine
Morphine is an opioid that acts on opioidergic receptors to modulate pain. Participants in the opioid arm will receive 0.1 mg/kg IV of morphine (10 mg maximum).
Drug: morphine



Primary Outcome Measures :
  1. Pain Treatment-VAS (Visual Analog Scale) [ Time Frame: At 0 minutes and 60 minutes ]
    Study outcomes involve change in participants' pain as measured by a visual analog scale. The scale is a 10 inch line from 0 to 10 inches with 10 being the most pain and 0 being no pain. There are no units on the scale; it is just a straight line from no pain (0) to the worst pain (10). We assessed at o, 15, and 60 minutes but only scored the VAS at 60 minutes.


Secondary Outcome Measures :
  1. Number of Participants With an Adverse Effects [ Time Frame: 60 minutes ]
    We will monitor for adverse effects and record for changes in vital signs including nausea and vomiting, hypotension, respiratory depression, laryngospasm, and emotional and psychological effects (emergence reactions).

  2. Would the Participant Would Consider Using the Drug Given to Them for Pain Relief in the Future [ Time Frame: 60 minutes ]
    Patients will be assessed to determine whether the participant would consider using the drug given to them for pain relief in the future. It was measured on a likert scale from 1-5 with 1 being did not like and would not use the drug again to 5 being like and would definitely receive the medication again. There are no units. The numbers below are the total number of patients that completed this answer. This was only asked on patients that received medication as if they did not receive medication the answer would not make sense. The median value is the likert value on a scale of 1-5 with the standard deviation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible Long bone fractures. This will include:
  • Humerus
  • Tibia
  • Fibula
  • Femur
  • Radius
  • Ulna

Exclusion Criteria:

  • Injuries older than 24 hours
  • Avulsion fractures
  • History of substance abuse
  • History of chronic opioid dependence
  • Pregnancy
  • Demonstrates signs of intoxication
  • Allergic to ketamine or opioids
  • Patients unable to consent
  • Hemodynamically unstable (SBP >180mmHg or <100mgHg, HR >130bpm, Respiratory rate <10, oxygen saturations <90%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430818


Locations
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United States, Missouri
Barnes Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
MOCEP
Investigators
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Principal Investigator: Nicholas Musisca, MD Physician
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:
Statistical Analysis Plan  [PDF] June 23, 2016
Study Protocol  [PDF] June 23, 2016


Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02430818    
Other Study ID Numbers: 201501068
First Posted: April 30, 2015    Key Record Dates
Results First Posted: May 22, 2019
Last Update Posted: May 22, 2019
Last Verified: April 2019
Keywords provided by Washington University School of Medicine:
ketamine
emergency medicine
orthopedics
Additional relevant MeSH terms:
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Acute Pain
Fractures, Bone
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Ketamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action