Back to resultsA Comparison of Morphine and Morphine Plus Dexmedetomidine in Chronic Cancer Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Morphine
Morphine plus dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic pain, Morphine, Dexmedetomidine
Eligibility 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
Sites / Locations
- Cukurova University Faculty of Medicine Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control
Morphine plus dexmedetomidine
Arm Description
Morphine, 0.02 mg/kg PCA bolus dose with 10 minutes lock-out interval
Morphine 0.02 mg/kg plus dexmedetomidine 0.1 microgram/kg PCA bolus dose with 10 minutes lock-out interval
Outcomes
Primary Outcome Measures
Morphine consumption (mg)
cumulative morphine consumption for 24 hours
Secondary Outcome Measures
Pain score
visual analog scale to assess pain degree
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02289261
Brief Title
A Comparison of Morphine and Morphine Plus Dexmedetomidine in Chronic Cancer Pain
Official Title
A Comparison of Morphine and Morphine Plus Dexmedetomidine in Chronic Cancer Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether dexmedetomidine added to morphine is effective in the treatment of chronic cancer pain.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic pain, Morphine, Dexmedetomidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Morphine, 0.02 mg/kg PCA bolus dose with 10 minutes lock-out interval
Arm Title
Morphine plus dexmedetomidine
Arm Type
Active Comparator
Arm Description
Morphine 0.02 mg/kg plus dexmedetomidine 0.1 microgram/kg PCA bolus dose with 10 minutes lock-out interval
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
morphine sulphate
Intervention Description
Morphine, 0.02 mg/kg PCA bolus dose with 10 minutes lock-out interval
Intervention Type
Drug
Intervention Name(s)
Morphine plus dexmedetomidine
Other Intervention Name(s)
Morphine sulphate plus dexmedetomidine
Intervention Description
Morphine 0.02 mg/kg plus dexmedetomidine 0.1 microgram/kg PCA bolus dose with 10 minutes lock-out interval
Primary Outcome Measure Information:
Title
Morphine consumption (mg)
Description
cumulative morphine consumption for 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain score
Description
visual analog scale to assess pain degree
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selcuk Gök, M.D
Organizational Affiliation
Cukurova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cukurova University Faculty of Medicine Research Hospital
City
Adana
ZIP/Postal Code
01130
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
22546966
Citation
Blaudszun G, Lysakowski C, Elia N, Tramer MR. Effect of perioperative systemic alpha2 agonists on postoperative morphine consumption and pain intensity: systematic review and meta-analysis of randomized controlled trials. Anesthesiology. 2012 Jun;116(6):1312-22. doi: 10.1097/ALN.0b013e31825681cb.
Results Reference
background
PubMed Identifier
18987053
Citation
Lin TF, Yeh YC, Lin FS, Wang YP, Lin CJ, Sun WZ, Fan SZ. Effect of combining dexmedetomidine and morphine for intravenous patient-controlled analgesia. Br J Anaesth. 2009 Jan;102(1):117-22. doi: 10.1093/bja/aen320. Epub 2008 Nov 5.
Results Reference
result
Learn more about this trial
A Comparison of Morphine and Morphine Plus Dexmedetomidine in Chronic Cancer Pain
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