Efficacy of preoperative alprazolam on postoperative pain in patients under elective abdominal surgery in Azad University hospitals
Design
106 people who underwent elective abdominal surgery were selected randomly, of which 53 were randomized in a double-blind, 0.5-mg alprazolam, and 53 placebo
Settings and conduct
In this interventional study conducted as a randomized clinical trial, 106 patients aged 20-60 years old with ASA, one or two, under elective abdominal surgery in Islamic Azad University hospitals for participation in Satisfaction Study They are not allergic to alprazolam, are available and are randomly selected and randomly divided into one of two groups receiving 0.5 mg oral alprazolam at night before surgery or placebo. And the amount of postoperative pain in them based on VAS in three times including recovery, first four hours and first 24 hours and the amount of analgesic used in the two groups were compared.
Participants/Inclusion and exclusion criteria
Entry requirements:
1. Elective surgery
2.Requests to participate in the study
3. American Statistical Classes 1 and 2
4.Age of between 20 and 60 years
5. No allergy to alprazolam
6. No drug addiction
Non-arrival conditions:
1. Surgery for more than 3 hours
2. Non-cooperation of the patient due to delirium after surgery
3. Complicated surgery
Intervention groups
Giving Alprazolam tab to intervention group and placebo tab to control group of patients undergoing to elective intra-abdominal surgery
Main outcome variables
Study of postoperative pain in patients under elective abdominal surgery with and without taking Alprazolam tablet
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140916019198N3
Registration date:2019-03-31, 1398/01/11
Registration timing:prospective
Last update:2019-03-31, 1398/01/11
Update count:0
Registration date
2019-03-31, 1398/01/11
Registrant information
Name
farshid gholami
Name of organization / entity
Islamic azad university , tehran medical branch
Country
Iran (Islamic Republic of)
Phone
+98 21 3318 7483
Email address
fgholami@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-05-05, 1398/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Alprazolam pre medication on postoperative pain of elective abdominal surgery
Public title
Alprazolam effect`s on acute pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elective abdominal surgery
Consent letter for study
A.S.A class I and II
Age between 20 to 60
No allergy to Alprazolam
No history of opium addiction
Exclusion criteria:
Operation time more than 3 hours
Post operative delirium
Complicated surgery
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
During preoperative visit of an anesthesiologist , The first patient who scheduled for elective intra-abdominal surgery will stay on a group by lion and for the rest of patient`s in between will be in two groups .
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients won`t know which group is . Drug prescriptive staff are unaware of division . Collector`s personnel are unaware of division too .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Medical Sciences Tehran Unit
Street address
Islamic Azad University of Medical Sciences Tehran Unit.,atari moghaddam avenu , shahid khaghani avenu , shariati street
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2017-01-03, 1395/10/14
Ethics committee reference number
IR.IAU.TMU.REC.1395.255
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
intensity of pain
Timepoint
in recovery, 4 and 24 hours after surgery
Method of measurement
Visual Analogue Scale ruler
Secondary outcomes
1
Description
postoperative pain
Timepoint
in recovery, 4 and 24 hours after surgery
Method of measurement
Visual Analogue Scale ruler
Intervention groups
1
Description
Intervention group: "Elective subjects who were randomly assigned to receive alprazolam half a milligram a day before surgery"
Category
Prevention
2
Description
Control group: A number of elective abdominal patients randomly selected They received placebo before the operation