In this study, we have to consider the role of ketamine in decreasing pain and the need for other analgesics including opioid after cesarean section on patients undergoing spinal anesthesia with bupivacaine which is routine method in our hospital.
This study is randomized clinical trials on pregnant women who are referring for elective cesarean section and to evaluate the effect of single dose intravenous ketamine in decreasing pain and the need for other analgesics after caesarean section.
Patients are divided into two random groups. All patients undergoing spinal anesthesia with bupivacaine by intrathecal injection and 5 minutes after removing the baby, first group receive ketamine 0.25 with slow intravenous injection and group II receive normal saline same amount. The complaint of pain for the first time after cesarean section and also requesting for analgesic will record.
For all patients at 1 - 2-6-12 hr postoperative, pain score is measured and ask about the side effects include nausea, vomiting, headache, hallucination, pruritus. During pain score measurement if the pain score was more than five and pain don't relieved with diclofenac suppository then 50mg pethidine intramuscularly will injected, and could repeated up to 3 doses in 24 hours after surgery, at least every 6 hours.
All observations recorded and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012100611019N1
Registration date:2013-07-09, 1392/04/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-09, 1392/04/18
Registrant information
Name
Mojgan Rahmanian
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1444 1022
Email address
rahmanian@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Financial resorces of Semnan University of Medical Sciences
Expected recruitment start date
2012-12-05, 1391/09/15
Expected recruitment end date
2013-07-05, 1392/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low dose intravenouse ketamine on post operative pain after cesarean section with spinal anesthesia
Public title
The effect of low dose intravenouse ketamine on post operative pain after cesarean section with spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included: Singleton pregnancy, semester, elective cesarean section; perform cesarean sections by Fan slices Ashtyl; not having a history of drug abuse; no history of chronic diseases such as diabetes; surgery with spinal anesthesia; no previous surgery;a level of intelligence cooperation; class ASA 1, 2
Exclusion criteria:excessive bleeding during and after surgery; Sensitivity to ketamine; psychological problems (psychotic disorder); contraindication for spinal anesthesia; Hypertension; High Icp; a history of seizures; history of ketamine use and hallucination after that.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
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
Semnan University of Medical Sciences
Street address
basij Bolvard
City
Semnan
Postal code
Approval date
2012-08-14, 1391/05/24
Ethics committee reference number
91/16/6184
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.9
ICD-10 code description
Generalized pain NOS
Primary outcomes
1
Description
Analgesia
Timepoint
ّIn the first day of study
Method of measurement
Pain Score
Secondary outcomes
empty
Intervention groups
1
Description
All patients received spinal anesthesia (BUPIVACAINE 7-12 mg intrathecally by needle No: 25 at L3-L4 space). Patients were randomly divided into two groups. First group receives Ketamin 0.25 mg/kg intravenously 5 minutes after section. The first time of pain complaint after cesarean section and request for analgesic recorded.
If the patient is requested analgesics, Diclofenac as rectal suppository 100mg prescribed and repeated at least every 6 hours up to 4 doses in 24 hours. If pain don't relieved by diclofenac suppository, pethidine 50mg intramuscularly administrated which can repeated at least every 6 hours up to 3 doses in 24 hours after surgery.
Category
Treatment - Drugs
2
Description
After spinal anesthesia as the first group, control group receives salin normal as placebo intrathecally 5 minutes after section. The first time of pain complaint after cesarean section and request for analgesic recorded. If the patient is requested analgesics, Diclofenac as rectal suppository 100mg prescribed and repeated at least every 6 hours up to 4 doses in 24 hours. If pain don't relieved by diclofenac suppository, pethidine 50mg intramuscularly administrated which can repeated at least every 6 hours up to 3 doses in 24 hours after surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al Momenin Hospital
Full name of responsible person
Mehri Leysi
Street address
Amir Al Momenin Hospital, Imam Hossein square
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohamad Reza Asgari
Street address
Basij Bolvard
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mehri Leysi
Position
Obstetrics and Gynecology resident
Other areas of specialty/work
Street address
Amiralmomenin hospital, Emam hosein Square
City
Semnan
Postal code
3519734731
Phone
+98 23 1446 3052
Fax
Email
mehrileysi @yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mojgan Rahmanian
Position
Gynecologists
Other areas of specialty/work
Street address
Amiralmomenin hospital, Emam Hosein Square
City
Semnan
Postal code
3519734731
Phone
+98 23 1446 3052
Fax
Email
rahmanian@sem-ums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research expert
Other areas of specialty/work
Street address
Fatemieh Hospital, 17th Shahrivar Boulvard
City
Semnan
Postal code
3518794431
Phone
+98 23 1332 8017
Fax
Email
mehrdadzahmatkesh@sem-ums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)