Reduction of postoperative pain and restlessness following cataract surgery.
Design
62/5000
Clinical trial with community-based control and randomized control group
Settings and conduct
Shahrood Imam Hosein hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male or female, 18 – 70 years old ASA class 1&2&3(, risk of anesthesia)
Exclusion criteria: A history of drug abuse, antihypertensive therapy, antidepressant, anticonvulsive, beta blocker, Fluvoxamine, digoxin, dextromethorphan and every complication during surgery or anesthesia
Intervention groups
Patients are randomly divided into two equal treatment groups: placebo(control) or group A and clonidine or group B with simple randomized method.
Main outcome variables
postoperative pain & agitation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170213032560N2
Registration date:2018-07-30, 1397/05/08
Registration timing:registered_while_recruiting
Last update:2018-07-30, 1397/05/08
Update count:0
Registration date
2018-07-30, 1397/05/08
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 935 621 4141
Email address
kalantari@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-10-11, 1395/07/20
Expected recruitment end date
2018-08-04, 1397/05/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of oral clonidine premedication on postoperative pain and agitation following cataract surgery under general anesthesia
Public title
Assessment of oral clonidine premedication on postoperative pain and agitation following cataract surgery under general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18-85 years
ASA class 1& 2 & 3
Exclusion criteria:
Exclusion criteria: A history of drug abuse, antihypertensive therapy, antidepressant, anticonvulsive, beta blocker, Fluvoxamine, digoxin, dextromethorphan and every complication during surgery or anesthesia
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
According to randomized quadruple blocks, researcher gives a predetermined series of 70 A and B cards to the ophtalomology ward nurse who is responsible for blinding of trial. Based on this pattern participants will assign in to either intervention (A) and take clonidine or control (B) group that take placebo one hour before operation.
Blinding (investigator's opinion)
Double blinded
Blinding description
Questionnaire has two parts with identical cod. Ophthalmology ward nurse, who is responsible for randomization and blinding of research, enclose the second part of questionnaire (post operative pain chart) to the patient medical record file.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Deputy of research, Shahroud University of Medical Sciences
Street address
Deputy of research, Shahroud University of Medical Sciences, 7th of Tir square, Shahroud, Iran Shahroud
Researcher uses 0-10 numeric pain rating scale for assessment of postoperative pain.
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, participant takes oral clonidine (Tablet 0.2 mg manufactured by Tolidaru corporation) with 30ml water one hour before operation. Ophthalmology ward nurse who is responsible for randomization supervises this procedure.
Category
Treatment - Drugs
2
Description
Control group: In controll group the patiens take 30 ml water with placebo one hour before operation. Ophthalmology ward nurse who is responsible for randomization supervises this procedure.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital, End of Ayatollah Towhidi avenue, Shahroud, Iran
Full name of responsible person
mahsa kalantari
Street address
Deputy Dean for research, Shahroud University of Medical Sciences, 7th of Tir square, Shahroud, Iran
City
shahroud
Province
Semnan
Postal code
4571984315
Phone
+98 23 3239 5054
Email
mahsa.kalantari92@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
mohammad hasan emamian
Street address
Seventh Tir Square - Shahrood University of Science and Technology - Vice Chancellor for Research
City
shahrood
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
emamian@shmu.ac.ir
Web page address
http://shmu.ac.ir/research/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
mahsa kalantari
Position
medical intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Seventh Tir Square - Shahrood University of Science and Technology - Vice Chancellor for Research
City
shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
mahsa.kalantari92@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
mahsa kalantari
Position
medical intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Seventh Tir Square - Shahrood University of Science and Technology - Vice Chancellor for Research
City
shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
mahsa.kalantari92@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
mahsa kalantari
Position
medical intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Seventh Tir Square - Shahrood University of Science and Technology - Vice Chancellor for Research
City
shahrood
Province
Semnan
Postal code
45719-84315
Phone
+98 24 3552 5589
Email
mahsa.kalantari92@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD