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A Comparison of Morphine and Morphine Plus Dexmedetomidine in Chronic Cancer 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: NCT02289261
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Ersel GULEC, Cukurova University

Brief Summary:
The purpose of this study is to determine whether dexmedetomidine added to morphine is effective in the treatment of chronic cancer pain.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Morphine Drug: Morphine plus dexmedetomidine Phase 4

Detailed Description:
We conduct the study in Cukurova University Faculty of Medicine Research Hospital after obtaining ethics committee approval and patient's informed consent. Patients with cancer pain are allocated into two group to receive Patient Controlled Analgesia with morphine or morphine plus dexmedetomidine.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Morphine and Morphine Plus Dexmedetomidine in Chronic Cancer Pain
Study Start Date : November 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: Control
Morphine, 0.02 mg/kg PCA bolus dose with 10 minutes lock-out interval
Drug: Morphine
Morphine, 0.02 mg/kg PCA bolus dose with 10 minutes lock-out interval
Other Name: morphine sulphate

Active Comparator: Morphine plus dexmedetomidine
Morphine 0.02 mg/kg plus dexmedetomidine 0.1 microgram/kg PCA bolus dose with 10 minutes lock-out interval
Drug: Morphine plus dexmedetomidine
Morphine 0.02 mg/kg plus dexmedetomidine 0.1 microgram/kg PCA bolus dose with 10 minutes lock-out interval
Other Name: Morphine sulphate plus dexmedetomidine




Primary Outcome Measures :
  1. Morphine consumption (mg) [ Time Frame: 24 hours ]
    cumulative morphine consumption for 24 hours


Secondary Outcome Measures :
  1. Pain score [ Time Frame: 24 hours ]
    visual analog scale to assess pain degree



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with chronic cancer pain
  • between 20-80 years old age

Exclusion Criteria:

  • the presence of severe systemic disease(cardiac, pulmonary, hepatic or renal)
  • psychiatric or neurologic disease
  • unable to communicate verbally
  • nausea and vomiting
  • patient's refusal

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): NCT02289261


Locations
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Turkey
Cukurova University Faculty of Medicine Research Hospital
Adana, Turkey, 01130
Sponsors and Collaborators
Cukurova University
Investigators
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Principal Investigator: Selcuk Gök, M.D Cukurova University

Publications of Results:
Other Publications:
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Responsible Party: Ersel GULEC, Ersel Gulec, Cukurova University
ClinicalTrials.gov Identifier: NCT02289261    
Other Study ID Numbers: MDICP01
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Keywords provided by Ersel GULEC, Cukurova University:
Chronic pain
Morphine
Dexmedetomidine
Additional relevant MeSH terms:
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Chronic Pain
Cancer Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Dexmedetomidine
Morphine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics