A Comparison of Morphine and Morphine Plus Dexmedetomidine in Chronic Cancer Pain

NCT ID: NCT02289261

Last Updated: 2018-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

Morphine, 0.02 mg/kg PCA bolus dose with 10 minutes lock-out interval

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Morphine, 0.02 mg/kg PCA bolus dose with 10 minutes lock-out interval

Morphine plus dexmedetomidine

Morphine 0.02 mg/kg plus dexmedetomidine 0.1 microgram/kg PCA bolus dose with 10 minutes lock-out interval

Group Type ACTIVE_COMPARATOR

Morphine plus dexmedetomidine

Intervention Type DRUG

Morphine 0.02 mg/kg plus dexmedetomidine 0.1 microgram/kg PCA bolus dose with 10 minutes lock-out interval

Interventions

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Morphine

Morphine, 0.02 mg/kg PCA bolus dose with 10 minutes lock-out interval

Intervention Type DRUG

Morphine plus dexmedetomidine

Morphine 0.02 mg/kg plus dexmedetomidine 0.1 microgram/kg PCA bolus dose with 10 minutes lock-out interval

Intervention Type DRUG

Other Intervention Names

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morphine sulphate Morphine sulphate plus dexmedetomidine

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Ersel GULEC

Ersel Gulec

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Selcuk Gök, M.D

Role: PRINCIPAL_INVESTIGATOR

Cukurova University

Locations

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Cukurova University Faculty of Medicine Research Hospital

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 22546966 (View on PubMed)

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.

Reference Type RESULT
PMID: 18987053 (View on PubMed)

Other Identifiers

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MDICP01

Identifier Type: -

Identifier Source: org_study_id

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