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Effects of Gabapentin on postoperative pain relife and opioid consumption after septal deviation surgery

Protocol summary

Summary
Gabapentin is an anticonvulsant drug that is increasingly used to control postoperative pain and is effective in empirical studies. The purpose of this study was to investigate the effect of gabapentin reduces postoperative pain and opioid consumption.this control trial was conducted on 62 patients, aged18-50 years with ASA class I&2 undergoing septal deviation surgery..patients were divided into treatment (n=31, 800mg oral Gabapentin) and control (n=31, Placebo) groups. Pain score at the time of 1, 4, 8, 12, 16, 20 and 24 h after surgery and Pethidine consumption in 24 hours are considered as primary outcomes and side effects such as nausea, vomiting, respiratory depression, dizziness, peripheral edema, diarrhea, headache and itching have been determined as secondary outcomes

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014051817742N1
Registration date: 2014-07-16, 1393/04/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-07-16, 1393/04/25
Registrant information
Name
Fatemeh Javaherforoosh Zadeh
Name of organization / entity
Ahvaz Joundishapoor University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1391 9315
Email address
javaherforosh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy Ahvaz Joundishapoor University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Gabapentin on postoperative pain relife and opioid consumption after septal deviation surgery
Public title
Gabapentin effect on postoperative pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA physical status class I, 2 who were scheduled nasal septum deviation surgery Ecriteria criteria: allergy to gabapentin; epilepsy; previous treatment with gabapentin; chronic pain syndrome; history of cardiovascular; respiratory, and renal or hepatic disease; psychiatric disorders; substance abuse
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Joundishapoor University of Medical Sciences
Street address
Golestan street, Ahvaz
City
Ahvaz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
p/8/20/1280

Health conditions studied

1

Description of health condition studied
Nasal septom pain
ICD-10 code
M79.6
ICD-10 code description
Pain in nose

Primary outcomes

1

Description
Pain score after surgery
Timepoint
at 1,4,8,12,16,20,24 hours after surgery
Method of measurement
VAS

Secondary outcomes

1

Description
petedin consumption
Timepoint
24 hours after surgery
Method of measurement
observation

Intervention groups

1

Description
Administration of 800 mg oral gabapentin one hour before surgery
Category
Treatment - Drugs

2

Description
Placebo one hour before surgery
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomini Hospital of Ahvaz
Full name of responsible person
Dr. Fatemeh Javaherforoosh Zadeh
Street address
Imam Khomini Hospital - Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Resurch Deputy Ahvaz Jondishapoor University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Ahvaz-Resurch Center Of Ahvaz Jondishapoor university
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Resurch Deputy Ahvaz Jondishapoor 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
Joundishapoor University Of Medical Sciences
Full name of responsible person
Dr. Fatemeh Javaherforoosh Zadeh
Position
Heart Anesthesia Felowship
Other areas of specialty/work
Street address
Imam Khomini Hospital-Ahwaz
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
Email
f_javaherforoosh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Joundishapoor University Of Medical Sciences
Full name of responsible person
Dr. Fatemeh Javaherforoosh Zadeh
Position
Heart Anesthesia Felowship
Other areas of specialty/work
Street address
Imam Khomini Hospital-Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
Email
f_javaherforoosh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Joundishapoor University Of Medical Sciences
Full name of responsible person
Dr.Fatemeh Javaherforoosh Zadeh
Position
Heart Anesthesia Felowship
Other areas of specialty/work
Street address
Imam Khomini Hospital-Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
Email
f_javaherforoosh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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