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Low Dose Ketamine Versus Morphine for Moderate to Severe Pain in the Emergency Department

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ClinicalTrials.gov Identifier: NCT01835262
Recruitment Status : Completed
First Posted : April 18, 2013
Results First Posted : August 27, 2015
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Antonios Likourezos, Maimonides Medical Center

Brief Summary:
The primary objectives of the study are to evaluate the efficacy of subdissociative dose intravenous ketamine compared with intravenous morphine in relieving acute pain in the ED. Secondary objectives will include the rate of adverse effects and need for rescue analgesia. The hypothesis is that intravenous administration of subdissociative dose ketamine at 0.3 mg/kg is superior to intravenous morphine at 0.1mg/kg in treating moderate and severe acute pain in patients presenting to the ED.

Condition or disease Intervention/treatment Phase
Pain Drug: Morphine Drug: Ketamine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Dose Ketamine Versus Morphine for Moderate to Severe Pain in the Emergency Department: A Prospective, Randomized, Double-Blind Study
Study Start Date : April 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Morphine
Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP
Drug: Morphine
Morphine: 0.1 mg /kg given as IVP

Experimental: Ketamine Group
Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP
Drug: Ketamine
Ketamine:0.3 mg/given as IVP




Primary Outcome Measures :
  1. Numeric Rating Scale of Pain [ Time Frame: 30 minutes ]

    We will compare efficacy as a difference between 2 groups in pain score at 30 minutes post-analgesic administration. The primary outcome is the difference between 2 groups in pain score at 30 minutes.

    Pain will be measured via Numeric rating scale from 0 to 10 with 0 being no pain, 5 being moderate pain, and 10 being severe pain




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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. ED patients18-55 years old presenting with moderate to severe (Numeric Pain Rating Score >5) acute (less than 7 days)
  2. abdominal, flank, back or musculoskeletal pain warranting (in the treating physician's judgment) administration of intravenous opioid pain medication.
  3. Patients must be awake, alert and oriented to time, place and person,
  4. patient must be able to demonstrate understanding of the informed consent.
  5. Patient must be able to verbalize how much pain they are having on the 10 point Numeric Rating Pain Scale,
  6. Patient mus be able to verbalize the nature of the side effects he may be experiencing from the intravenous analgesia.

Exclusion Criteria:

  1. Pregnancy or breast feeding
  2. SBP<90
  3. Weight greater than 115kg or less than 45kg,
  4. altered mental status,
  5. allergy to ketamine or morphine,
  6. history of acute head or ocular trauma
  7. presence of intracranial mass or vascular lesion, presence of psychiatric history
  8. diagnosis or treatment (as assessed by electronic chart review).
  9. history of seizure or intracranial hypertension
  10. history of chronic pain, pain syndrome or fibromyalgia
  11. presence of cardiovascular disease except controlled hypertension
  12. history of acute head or ocular trauma, drug or alcohol abuse in the preceding 6 months
  13. drugs or alcohol abuse in the preceding 6 months
  14. SBP>180
  15. HR<50
  16. HR>150
  17. RR<10
  18. RR>30
  19. administration of opiate pain medication in the past 4 hours prior to assessment (i.e. home, EMS, triage, office, etc.)
  20. presence of renal or hepatic insufficiency (as assessed by electronic chart review),

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): NCT01835262


Locations
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United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Antonios Likourezos
Investigators
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Principal Investigator: Sergey Motov, MD Maimonides Medical Center

Publications:
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Responsible Party: Antonios Likourezos, Research Manager, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT01835262     History of Changes
Other Study ID Numbers: 12/09/VA01
12-09-VA01 ( Other Identifier: Maimonides Medical Center IRB )
First Posted: April 18, 2013    Key Record Dates
Results First Posted: August 27, 2015
Last Update Posted: February 29, 2016
Last Verified: October 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Antonios Likourezos, Maimonides Medical Center:
pain
Ketamine
Emergency Medicine
morphine

Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
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