Objectives: Evaluation of the analgesic effects of duloxetine in burn patients Design: This study is a randomized open label clinical trial. Forty two patients from 1 center will be entered to the study. Patients will be randomly assigned to the intervention or control group based on simple block randomization.
Setting: Patients will receive a 60 mg capsule of duloxetine per day in the intervention group. In the control group patients will receive no treatment. The patients will remain in the study for 3 weeks or for entire time of the hospitalization (which is shorter than the other) Participants: Patients who require hospitalization for at least 1 week will be recruited. Patients with hepatic failure, bipolar mood disorder and creatinine clearance less than 30 ml per minute and who are receiving potent inhibitors of cytochrome P450 (CYP) 2D6 and CYP1A2, will be excluded.
Main outcome measures: Primary outcome variables: The severity and quality of the pain. These variables will be evaluated using visual analog scale and neuropathic pain scale. Secondary outcome variables: Dose of the other analgesic drugs that patients will receive during the study and adverse effects. Adverse effects will be recorded based on the patients’ reports.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051422637N4
Registration date:2017-05-31, 1396/03/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-31, 1396/03/10
Registrant information
Name
Naemeh Nikvarz
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5017
Email address
nnikvarz@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2017-01-30, 1395/11/11
Expected recruitment end date
2017-12-02, 1396/09/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the analgesic effects of duloxetine in burn patients
Public title
Evaluation of the analgesic effects of duloxetine in burn patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Burn patients requiring hospitalization for at least one week
Exclusion criteria: Bipolar mood disorder; consuming monoamine oxidase inhibitor drugs, three cyclic antidepressant drugs, tramadol, buspirone, triptan drugs, lithium, ondansetron, potent inhibitors of cytochrome P450 (CYP450) 2D6 and CYP450 1A2; creatinine clearance less than 30 ml per minute; hepatic failure; uncontrolled epilepsy; thrombocytopenia
Age
From 15 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Vice chancellor for research, Ebn-e-Sina Street
City
Kerman
Postal code
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
IR.KMU.REC.1395.680
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T20-T25
ICD-10 code description
Burns and corrosions of external body surface, specified by site
Primary outcomes
1
Description
Severity of pain
Timepoint
At baseline and every other day
Method of measurement
Visual Analog Scale
2
Description
Severity and quality of pain
Timepoint
At baseline and every other day
Method of measurement
Neuropathic Pain Scale
Secondary outcomes
1
Description
Dose of other analgesic drugs
Timepoint
At the end of the study
Method of measurement
Recording the dose of other analgesics
2
Description
Adverse effects
Timepoint
During the study
Method of measurement
Patient report
Intervention groups
1
Description
Intervention: a 60 mg oral capsule of duloxetine per day
Category
Treatment - Drugs
2
Description
Control: No treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Naemeh Nikvarz
Street address
Shafa Hospital, Kowsar Boulevard
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Vice chancellor for research, Ebn-e-sina Street
City
Kerman
Grant name
ندارد
Grant code / Reference number
95000039
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ali Najafi
Position
Pharmacy student
Other areas of specialty/work
Street address
Faculty of Pharmacy, Haft-Bagh Road
City
Kerman
Postal code
7616911319
Phone
+98 34 3132 5000
Fax
+98 34 3132 5003
Email
najafiali57@yahoo.com
Web page address
Not available
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Naemeh Nikvarz
Position
Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Faculty of Pharmacy, Haft Bagh Road
City
Kerman
Postal code
7616911319
Phone
+98 34 3132 5017
Fax
+98 34 3132 5003
Email
nnikvarz@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Naemeh Nikvarz
Position
Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Faculty of pharmacy, Haft Bagh Road
City
Kerman
Postal code
7616911319
Phone
+98 34 3132 5017
Fax
+98 34 3132 5003
Email
nnikvarz@kmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)