The Effect of a single preoperative dose of300 mg Gabapentin on Postoperative Pain in Rhinoplasty
Design
This study is double-blinded clinical trial.The study population will be included all patients refer to Imam Khomeini hospital of Kermanshah city.128 eligible patients will be selected conveniently and randomly will be assigned to intervention and control groups.
Settings and conduct
This study, which will be conducted at Imam Khomeini hospital of Kermanshah city is double- blinded one, that participants and clinical carers will be blinded to the study groups, dose of drug and the drug manufacturer.The severity of postoperative pain of both groups is recorded in a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria:No history of diabetes, kidney and liver disease; No history of drug abuse
Exclusion criteria:Patients who has used Painkiller daily or within 24 hours before surgery ;surgeon; Patients who use antidepressants, anti-epilepsy or antihypertensive drugs
Intervention groups
The intervention group will receive 300 mg of gabapentin capsules one hour before the start of the study.The control group will receive 300 mg of placebo capsules an hour before the start of the study.
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N107
Registration date:2018-12-08, 1397/09/17
Registration timing:prospective
Last update:2018-12-08, 1397/09/17
Update count:0
Registration date
2018-12-08, 1397/09/17
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-16, 1397/09/25
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of a single preoperative dose of300 mg Gabapentin on Postoperative Pain in Rhinoplasty
Public title
The Effect of a single preoperative dose of Gabapentin on Postoperative Pain in Rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No history of diabetes, kidney and liver disease
No history of drug abuse
Exclusion criteria:
Patients who has used Painkiller daily or within 24 hours before surgery
Patients who use antidepressants, anti-epilepsy or antihypertensive drugs
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Individual randomization by random number table with code receipt
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and clinical carers will be blinded to the study groups, the dosage of the drug and the manufacturer of the drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-07-19, 1396/04/28
Ethics committee reference number
ir.kums.rec.1396.186
Health conditions studied
1
Description of health condition studied
post-operative pain after rhinoplasty
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
Intensity of pain
Timepoint
Beginning of study, 2, 4, 6, 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale(VAS)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive 300 mg of gabapentin capsules one hour before the start of the study.
Category
Treatment - Drugs
2
Description
The control group will receive 300 mg of placebo capsules an hour before the start of the study.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Masomeh Foladvand
Street address
Emam Khomeini Hospital, Naghliyeh Street
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3727 9104
Email
hani63210@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Masomeh Foladvand
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry,Shariati Street,
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
hani63210@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hesamodin Nazari
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Faculty of Dentistry,Shariati Street,
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
h.nazari@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Masomeh Foladvand
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry,Shariati Street,
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
hani63210@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail