The aim of this study was to determine the effect of low dose (0.15 mg/kg) of ketamin on postoperative pain and analgesic consumption after cesarean section. In a randomized double blind clinical trial study, 120 women undergoing elective cesarean section in Tleghani Hospital, Arak were studied. Ketamine (0.15 mgkg-1) or an equal volume of normal saline was given intravenously immediately after initiating spinal anesthesia in the intervention and control group, respectively. Techniques of anesthesia and surgery were the same in both groups. Postoperative pain was assessed by visual analogue scale (VAS) and homodynamic signs, drowsiness of mother and Apgar scores after cesarean, analgesic consumption and first time of analgesic administration were recorded at 5 visits (the first at recovery then every 6 hours).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811173289N1
Registration date:2010-08-27, 1389/06/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-08-27, 1389/06/05
Registrant information
Name
Esmail Moshiri
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
dr_moshiri@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2009-10-05, 1388/07/13
Expected recruitment end date
2010-02-11, 1388/11/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low dose Ketamine on postoperative pain after spinal anesthesia in cesarean section
Public title
The effect of low dose Ketamine on postoperative pain after spinal anesthesia in cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having a term pregnancy, Class ASA І & Π
Exclusion Criteria: having a pregnancy problem such as hypertension or GTM in pregnancy or infant problem
Age
No age limit
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
Arak University of Medical Sciences, Sardasht, Arak
City
Arak
Postal code
Approval date
empty
Ethics committee reference number
3-64-88
Health conditions studied
1
Description of health condition studied
Delivery by caesarean section, unspecified
ICD-10 code
O82.9
ICD-10 code description
Delivery by caesarean section, unspecified
Primary outcomes
1
Description
The first time that pain killer is necessary
Timepoint
Every 30 min
Method of measurement
visual scale
2
Description
pain severity
Timepoint
Every 30 min
Method of measurement
visual scale
Secondary outcomes
1
Description
mother's pulse rate
Timepoint
Every 30 min
Method of measurement
pulse oxymetery
2
Description
mother's O2 saturation
Timepoint
Every 30 min
Method of measurement
pulse oxymetery
3
Description
mother's blood pressure
Timepoint
Every 30 min
Method of measurement
blood pressure monitor
4
Description
infant's apgar score
Timepoint
Every 30 min
Method of measurement
apgar score pattern
5
Description
mother's sedation
Timepoint
Every 30 min
Method of measurement
ramsay
Intervention groups
1
Description
Spinal anesthesiology was done by anesthesiologist in L3-L4 spaces with spinal needle number G25. In both groups anesthesia was done by xylocaine (5%) 2cc (made by ORIOM Pharm). Xylocaine prescribed 75 - 100 mg according to patient height. Immediately after spinal anesthesia, ketamine 15 / 0 mg per kg was injected intravenously. Ketamine made by ROPEX MEDICA factory, including 50 mg /cc ketamine.
Category
Prevention
2
Description
Spinal anesthesiology was done by anesthesiologist in L3-L4 spaces with spinal needle number G25. In both groups anesthesia was done by xylocaine (5%) 2cc (made by ORIOM Pharm). Xylocaine prescribed 75 - 100 mg according to patient height. Normal saline was injected as the same volume of ketamine ( 15/0 mg/ kg).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Esmail Moshiri
Street address
Vali e Asr hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Saeed Ashtyani
Street address
Arak University of Medical Sciences
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 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
Arak University of Medical Sciences
Full name of responsible person
Nafiseh Gazerani
Position
M.S. in Midwifery
Other areas of specialty/work
Street address
Arak Medical University Journal office, Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 1417 3548
Fax
+98 86 1417 3548
Email
nafis_ob_2004@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Esmail Moshiri
Position
Anesthesiologist
Other areas of specialty/work
Street address
Vali e Asr hospital
City
Arak
Postal code
Phone
+98 86 1222 2003
Fax
Email
dr_moshiri@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nafiseh Gazerani
Position
M.S. in Midwifery
Other areas of specialty/work
Street address
Arak Medical University Journal office, Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 1417 3548
Fax
Email
nafis_ob_2004@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)