NCT02289261

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 chronic-pain

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_4 chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

November 10, 2014

Last Update Submit

June 18, 2018

Conditions

Chronic Pain

Keywords

Chronic painMorphineDexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption (mg)

    cumulative morphine consumption for 24 hours

    24 hours

Secondary Outcomes (1)

  • Pain score

    24 hours

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Drug: Morphine

Morphine plus dexmedetomidine

ACTIVE COMPARATOR

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

Drug: Morphine plus dexmedetomidine

Interventions

MorphineDRUG

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

Also known as: morphine sulphate
Control
Morphine plus dexmedetomidineDRUG

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

Also known as: Morphine sulphate plus dexmedetomidine
Morphine plus dexmedetomidine

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University Faculty of Medicine Research Hospital

Adana, 01130, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 22546966BACKGROUND

  • 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.

    PMID: 18987053RESULT

MeSH Terms

Conditions

Chronic Pain

Interventions

MorphineDexmedetomidine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Selcuk Gök, M.D

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ersel Gulec

Study Record Dates

First Submitted

November 10, 2014

First Posted

November 13, 2014

Study Start

November 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 19, 2018

Record last verified: 2018-06

Locations

TU(1)