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Scientific title:To study the effect of intravenous low dose ketamin on the severity of pain and the need for analgesics in patients operated with cesarean section with spinal anesthesia in Al-Zahra hospital during2011

Protocol summary

Summary
The objective of this study is to study the effect of low dose intra venous ketamin for decreasing the need for analgesics in patients operated with cesarean section with spinal anesthesia in Al- Zahra hospital. This study will be performed on 60 term single pregnant women in Rasht Al-Zahra hospital. After written and informed consent to participate in the survey, subjects were divided by Block Randomization into two groups (A&B). Control group will be treated with 2cc Normal Saline as placebo and intervention group will be treated with 0.2mg/kg ketamin plus 2cc Normal Saline. Immediately after spinal anesthesia drug of group A or B will be prescribed by an anesthesiologist informed about the kind of drug. After the end of operation in minutes: 0,30,60,90,120,150,180 and hours: 6,12,18,24 , the patient is visited by an assistant who doesn’t know the group of patient and pain visual scale (VAS), (That was explained previously for the patient) and the need for analgesic will be evaluated. If the score is up to 5, 200 mg/day diclofenac suppository (maximum 2 dose 100 mg/day) is given and if more analgesic is necessary 50 mg intra muscular pethidine is recommended. The time of the first request of the analgesic, total analgesics used and pain score in mentioned hours is registered. Finally achieved results of relief pain in both groups will be compared by using statistical methods.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201103133485N2
Registration date: 2011-06-14, 1390/03/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-06-14, 1390/03/24
Registrant information
Name
Forozan Milani
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1722 9328
Email address
milani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Guilan university of medical sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Scientific title:To study the effect of intravenous low dose ketamin on the severity of pain and the need for analgesics in patients operated with cesarean section with spinal anesthesia in Al-Zahra hospital during2011
Public title
To study the effect of intravenous low dose ketamin on the severity of pain and the need for analgesics in patients operated with cesarean section with spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria's: 1) Pregnant women with single pregnancy, term, candidate for elective cesarean, 2) Cesarean with pfanenstail incision, 3) No history of drug abuse, 4) Absence of chronic disease such as diabetes mellitus, hypertension, preeclampsia, infection, 5) Surgery performed with the spinal anesthesia by using epinephrined lidocaine, 6) No history of surgery, 7) Having a level of intelligence for optimum cooperation, 8)ASA1 class, 9) Patient with pain score more than 5. Exclusion criteria's: 1) Bleeding after surgery, 2) Definite sensitivity to ketamin, 3) Mental and psychological problems., 4) Contraindication for spinal anesthesia, 5) Past history of hypertension, 6) Increased intracranial pressure. 7) Past history of seizure, 8) Past history of hallucination after ketamin, 9) Class ASA > 1
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethic committee Guilan University of Medical Sciences
Street address
Melat st, Namjoo Ave
City
Rasht
Postal code
Approval date
2011-03-14, 1389/12/23
Ethics committee reference number
35

Health conditions studied

1

Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
O74.8
ICD-10 code description
Other complications of anaesthesia during labour and delivery

Primary outcomes

1

Description
Determining the effect of low dose intra venous ketamin compared with intra venous Normal saline on the severity of pain and the need for analgesic in cesarean patients with spinal anesthesia.
Timepoint
0,30,60,90,120,150,180 minutes and 6,12,18,24 hours after cesarean
Method of measurement
Pain score in visual scale in 0,30,60,90,120,150,180 minutes and 6,12,18,24 hours after cesarean section, the time of the first request analgesic, total received analgesics

Secondary outcomes

1

Description
Comparing the pain score after surgery in patients with intra venous ketamin versus intra venous Normal saline group
Timepoint
0,30,60,90,120,150,180 minutes and 6,12,18,24 hours after cesarean section.
Method of measurement
Pain visual scale.

2

Description
Determining the relative frequency of hallucination in group with intravenous ketamin
Timepoint
First 24 hours after cesarean section
Method of measurement
According to patient's answers

3

Description
Determining the time point from ending cesarean section to the first dose of analgesic in patients with intra venous ketamin.
Timepoint
The first 24 hours after cesarean section
Method of measurement
Time of the first request for analgesic (suppository diclofenac)

4

Description
Determining newborn apgar score in group using intra venous Normal saline
Timepoint
First and fifth minutes after birth
Method of measurement
Including 5 sections: heart rate, breathing, effort muscular tone, reflexes, color

5

Description
Comparing the newborn mean apgar in using Normal saline versus intra venous ketamin
Timepoint
First and fifth minutes after birth
Method of measurement
Including 5 sections: heart rate, breathing, effort muscular tone, reflexes, color

6

Description
Determining the relative frequency of complications (vomiting, nausea, headache) in patients using intra venous ketamin
Timepoint
First 24 hours after cesarean section
Method of measurement
Nausea and headache: according to patient’s words. Vomiting : observation expulsion of content with pressure upper gastro intestinal

7

Description
Determining the relative frequency of complications (vomiting. nausea, headache) in patient by using Normal saline
Timepoint
First 24 hours after cesarean section
Method of measurement
Nausea and headache: according to patient’s words. Vomiting: Observation expulsion of content with pressure upper gastro intestinal

8

Description
Comparing the relative frequency in group with intra venous ketmin versus intravenous Normal saline
Timepoint
First 24 hours after cesarean section
Method of measurement
Nausea and headache: according to patient’s words. Vomiting: observation expulsion of content with pressure upper gastro intestinal

9

Description
Determining newborn apgar score in group using intra venous ketamin
Timepoint
First and fifth minutes after birth
Method of measurement
Including 5 sections: heart rate, breathing, effort muscular tone, reflexes, color

10

Description
Determining the time point from ending cesarean section the first dose of analgesic in patients in Normal saline group
Timepoint
The first 24 hours after cesarean section.
Method of measurement
Time of the first request for analgesic (diclofenac suppository)

11

Description
Comparing the time point from ending cesarean section to the first analgesic in group with intra venous ketamin versus intra venous Normal Saline group
Timepoint
The first 24 hours after cesarean section
Method of measurement
Time of the first request for analgesic (Diclofenac suppository)

12

Description
Determining the pain score after surgery in patients with cesarean with spinal anesthesia using intra venous normal saline
Timepoint
,30,60,90,120,150,180 minutes and 6,12,18,24 hours after cesarean section
Method of measurement
Pain visual scale.

13

Description
Comparing the mean dose of pethidine in group with intra venous ketamin versus intra venous Normal saline group.
Timepoint
First 24 hours after cesarean section
Method of measurement
Dose of used pethidine. (mg/kg)

14

Description
Determining the pain score after surgery in patients with cesarean with spinal anesthesia using intra venous ketamin.
Timepoint
0,30,60,90,120,150,180 minutes and 6,12,18,24 hours after cesarean section
Method of measurement
Pain visual scale.

15

Description
Determining the mean dose of used pethidin in group of intra venous ketamin
Timepoint
First 24 hours after cesarean
Method of measurement
Dose of used pethidin. (mg/kg)

16

Description
Determining the mean dose of used pethidin in group of using Normal saline
Timepoint
First 24 hours after cesarean section
Method of measurement
Dose of used pethidin. (mg/kg)

17

Description
Comparing the mean dose of sodium diclofenac suppository in patient using intra venous ketamin versus Normal saline
Timepoint
First 24 hours after cesarean section
Method of measurement
Score more than 5 in pain visual scale.

18

Description
Determining mean dose used sodium diclofenac suppository in the group by using Normal saline
Timepoint
First 24 hours after cesarean
Method of measurement
Number of used suppositories

19

Description
Determining of the mean dose of sodium diclofenac suppository in group using intra venous ketamin
Timepoint
The first 24 hours after cesarean.
Method of measurement
Number of used suppository

Intervention groups

1

Description
2cc Normal saline in control group as placebo
Category
Placebo

2

Description
0.2 mg/kg intra venous ketamin+ 2 ‍cc normal saline in intervention group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra hospital, Guilan University of Medical Sciences
Full name of responsible person
Dr Forozan milani
Street address
Al-Zahra hospital, Namjo street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research, Guilan University of Medical Sciences
Full name of responsible person
Dr. Abdolrasol Sobhani
Street address
Mellat St., Namjoo Ave.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Dr Forozan Milani
Position
Obstetrics Gynecologist, Fellowship prenatalogy
Other areas of specialty/work
Street address
Reproduction Health Research Center, Al-Zahra hospital, Namjo street
City
Rasht
Postal code
Phone
+98 13 1322 5624
Fax
Email
forozanmilani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Forozan Milani
Position
Obstetrics Gynecologist, fellowship prenatalogy
Other areas of specialty/work
Street address
Reproductive health Research Center, Al-Zahra Hospital, Namjoo Avenue
City
Rasht
Postal code
Phone
+98 32 25624
Fax
Email
forozanmilani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Reproduction Health Research Center
Full name of responsible person
Seyedeh Maryam Mousavi Chahardeh
Position
Obstetrics
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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