The goal of this research is to study of comparison of addition of Fentanyl and Ketamin to 5/1% lidocaine with paracervical block in reducing of post operative pain in curettage. The method of study is randomized, double blind, placebo controlled clinical trial. Study population women candidate for curettage referred to Taleghani Hospital, Arak, Iran. Inclusion criteria: patient candidate curettage; age 20-45 years old; informed written consent for paracervical block. Exclusion criteria: prolonged procedure >20 minutes; failure of block and need to general analgesia; allergy to analgesic substances occurring of any heart diseases. 120 patients are randomly divided in 3 groups .The first group receive lidocaine 1/5% 5cc plus fentanyl 100 mg. The second group receive lidocaine 1/5% 5cc plus ketamine 50 mg .The third group receive lidocaine 1/5% 5cc plus placebo2 cc. Pain score has detected by VAS after 30 and 60 minute end of procedure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305204686N7
Registration date:2013-05-24, 1392/03/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-24, 1392/03/03
Registrant information
Name
Mehri Jamilian
Name of organization / entity
School of Medicine, Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1278 0660
Email address
mjamilian@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2013-03-11, 1391/12/21
Expected recruitment end date
2013-08-12, 1392/05/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of adition of Fentanyl and Ketamin to 5/1% lidocaine with paracervical block in reducing of post operative pain in curettage
Public title
Comparision of adition of Fentanyl and Ketamin to 5/1% lidocaine with paracervical block in reducing of post operative pain in curettage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient candidate curettage; age 20-45 years old; informed written consent for paracervical block.
Exclusion criteria: prolonged procedure >20 minutes; failure of block and need to general analgesia; allergy to analgesic substances occurring of any heart diseases.
Age
From 20 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Arak University of Medical Sciences
Street address
Basij Square
City
Arak
Postal code
3819691187
Approval date
2013-03-11, 1391/12/21
Ethics committee reference number
4-131-91
Health conditions studied
1
Description of health condition studied
local anaesthesia
ICD-10 code
X44
ICD-10 code description
agents primarily acting on smooth and skeletal muscles and the respiratory system
Primary outcomes
1
Description
Pain
Timepoint
30 and 60 minutes after intervention
Method of measurement
Clinical examination
Secondary outcomes
1
Description
Drug side effects
Timepoint
30 and 60 minutes after intervention
Method of measurement
Clinical examination
Intervention groups
1
Description
First group(40 persons) receive lidocaine 1/5% 5cc plus fentanyl 100mg
Category
Treatment - Drugs
2
Description
Second group (40 persons) receive lidocaine 1/5% 5cc plus ketamin 50mg
Category
Treatment - Drugs
3
Description
Third group (40 persons) lidocaine 1/5% 5cc plus placebo 2cc
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Street address
Basij square
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medival Sciences
Full name of responsible person
Dr.Ashtiyani
Street address
Basij Square
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medival 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
Arak University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Position
Board of Obstetric and Gynecology, Assistant Professor
Other areas of specialty/work
Street address
Taleghani Hospital
City
Arak
Postal code
3819691187
Phone
+98 86 1278 0660
Fax
+98 86 1278 8301
Email
mjamilian@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical sciences
Full name of responsible person
Mehri Jamilian
Position
Board of Obstetric and Gynecology, Assistant professor
Other areas of specialty/work
Street address
Taleghani Hospital
City
Arak
Postal code
Phone
+98 86 1278 0660
Fax
Email
mjamilian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Position
Boadr of Obstetric
Other areas of specialty/work
Street address
Taleghani Hospital
City
Arark
Postal code
Phone
+98 86 1278 0660
Fax
Email
mjamilian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)