In this double blind randomized clinical trail, 80 patinets 18-60 ASA1-2 who scaduled for Dacryo Cysto Rhinostomy in Rasul–e–Akram hospital were enrolled and assigned in two pregabalin and placebo groups randomly. Patients in pregabalin group had taken oral pregabalin (300) mg one hour pre surgical procedure, the others received placebo. Pain level and incidence of nausea and vomiting were compared between two groups at 4, 8, 12, 16, 20 and 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102185857N1
Registration date:2012-01-21, 1390/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-21, 1390/11/01
Registrant information
Name
Mahzad Alimian
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 0158
Email address
m-alimian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2010-03-11, 1388/12/20
Expected recruitment end date
2011-07-11, 1390/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the analgesic effect of Pregabalin in post Dacryo Cysto Rhinostomy (DCR) Pain Management
Public title
Evaluation of the analgesic effect of Pregabalin in post surgery patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-age between 18-60 2-candidated for surgery 3-signing informed consent to enter to this study. Exclusion criteria: 1-history of Hypertension- Diabet Mellitus- Ischemic heart disease- Renal and hepatic disease 2-Addiction 3-ASA or NSAIDS users for a long time
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Hemat high way, Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2010-02-21, 1388/12/02
Ethics committee reference number
پ989
Health conditions studied
1
Description of health condition studied
General anesthesia
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Pain mesaured by VAS
Timepoint
At recovery, then 30 min, 2, 4, 12, 24 hours after the surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Nausia and vomiting rate
Timepoint
in the recovery 30 min- 2-4-12-24 hours after the surgery
Method of measurement
asking from the patient
Intervention groups
1
Description
Patients in pregabalin group had taken oral pregabalin (300) mg one hour before surgery
Category
Treatment - Drugs
2
Description
Placebo group received placebo capsules filled with vitamine C