1.Objectives:The main objective of the study is to compare the analgesic effect of intravenous and intrathecal methods on labor pain.2. Design:Design of study is a randomized single blind. 3.Sample size:120 pregnant women admitted to Kosar Hospital are selected.4.Participants including major eligibility criteria :the inclusion criteria are candidate for natural delivery and being in active phase, and exclusion criteria is the lack of consent of the pregnant mother. 5.Intervention:The study group 1 receives 1g of intravenous acetaminophen with 0.3 mg / kg of ketamine with maintenance dose. The group study 2 undergoes spinal anesthesia by 5 micrograms of sufentanil.6.Main outcome measures:Pain evaluation will be done by using VAS at 10, 20, 30 minutes, and then every 1 hour for 4 hours. The duration of the first and second stage of labor, the fetal heart rate, side effects of the drug, and the first and fifth minutes Apgar score of neonate and respiratory depression in the neonate (if there is) will be recorded.
General information
Acronym
NO
IRCT registration information
IRCT registration number:IRCT2017082935979N1
Registration date:2017-11-14, 1396/08/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-14, 1396/08/23
Registrant information
Name
Mona Koochak Pour
Name of organization / entity
Qazvin University Of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 28 3323 6375
Email address
m.koochackpour@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
lnvestigator
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the analgesic effect of intrathecal Sufentanil with intravenous Acetaminophen in combination with low-dose ketamine onl abor pain
Public title
Comparing the analgesic effect of intrathecal Sufentanil with intravenous Acetaminophen in combination with low-dose Ketamine on labor pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are as follows:
o Pregnant women who are candidates for natural delivery and are in the active phase (Cervical dilatation of 5-3 cm);
o Pregnant women with no history of physical and psychological illness or biochemical abnormalities (ASA I class);
o Pregnant women who have written and complete consent for the study.
Exclusion criteria are as follows:
o Dissatisfaction pregnant women;
o Mother's preeclampsia and eclampsia;
o Insulin-dependent diabetes;
o Mother drug abuse history;
o Using any analgesic method before entering the study;
o History of liver disease;
o History or presence of bleeding disorder and coagulation disorders in the mother;
o using anticoagulant drugs;
o History of mental illness or using antidepressants or anticonvulsants;
o Any contraindication for spinal anesthesia;
o History of allergic reactions or intolerant to the drugs studied (Sufentanil, acetaminophen and ketamine);
o Any significant or severe systemic disease that limits usual and natural activities (such as kidney disease that require dialysis, class 2 heart failure and ….).
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Qazvin University Of Medical Sciences
Street address
Bahonar Bulvar,Qazvin
City
Qazvin
Postal code
Approval date
2017-04-08, 1396/01/19
Ethics committee reference number
IR.QUMS.REC.1396.4
Health conditions studied
1
Description of health condition studied
Analgesia in Labour
ICD-10 code
O74
ICD-10 code description
Maternal complications arising from the administration of a general or local anaesthetic, analgesic or other sedation during labour and delivery
Primary outcomes
1
Description
Pain
Timepoint
During the intervention
Method of measurement
VAS
Secondary outcomes
1
Description
Age
Timepoint
During Of Intervention
Method of measurement
Year
2
Description
Weight
Timepoint
During Of Intervention
Method of measurement
kilogram
3
Description
First stage of Labour
Timepoint
During Of Intervention
Method of measurement
Minute
4
Description
Neonate APGAR
Timepoint
During Of Intervention
Method of measurement
1to10
5
Description
Blood Pressure
Timepoint
During Of Intervention
Method of measurement
Mm Hg
6
Description
Ephedrine Amount
Timepoint
During Of Intervention
Method of measurement
mg
7
Description
Heart Beat
Timepoint
During Of Intervention
Method of measurement
Beat per minute
8
Description
Nausea and Vomiting
Timepoint
During Of Intervention
Method of measurement
Yes/NO
9
Description
Amount of Natural delivery
Timepoint
During Of Intervention
Method of measurement
Number
10
Description
Petedin Amount
Timepoint
During Of Intervention
Method of measurement
mg
11
Description
Second Stage Of Labour
Timepoint
During Of Intervention
Method of measurement
Minute
Intervention groups
1
Description
Intervention group :1000 mg of intravenous acetaminophen in 100 ml of normal saline will be injected intravenously in 15 minutes with 0.03 mg / kg of ketamine, and the maintenance dose of ketamine is dosed at a rate of 0.3 mg / kg / hour after 30 minutes from the initial dose and after completing the dilatation or in the event of sleepiness and failure to respond to the simple instructions, it's discontinued.
Category
Treatment - Drugs
2
Description
Control group: Spinal anesthesia will be performed in sitting position by needle number 25 and through inter-vertebral spaces of L3-L4 or L4-L5. 5 μg of sufentanil (1 ml) will be used for spinal anesthesia. Immediately after spinal anesthesia, the pregnant woman will be placed in the back and horizontal position, and she is in this situation for 5 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin Kosar Medical Education Center
Full name of responsible person
Dr.Mona Koochak Pour
Street address
Labour Department,kosar Hospital,Taeghani Street,Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research in Qazvin university of medical sciences
Full name of responsible person
Dr.amir peymani
Street address
Vice Chancellor for Research and Technology, Mavedeat Ave, Shahid Beheshti Bulvar, Qazvin
City
Qazvin
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 in Qazvin 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
Qazvin University Of Medical Sciense
Full name of responsible person
Mona Koochak Pour
Position
OBGYN Medical Assistant
Other areas of specialty/work
Street address
Kosar Medical Education Center,Taleghani Street,Qazvin
City
Qazvin
Postal code
Phone
+98 28 3323 6375
Fax
Email
Mon_470@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University Medical Sceinces
Full name of responsible person
Mona Koochak Pour
Position
OBGYN Medical Assistant
Other areas of specialty/work
Street address
Kosar Medical Education Center,Taleghani Street, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3323 6375
Fax
Email
mon_470@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kosar Medical Education Center
Full name of responsible person
Mona koochak Pour
Position
OBGYN Medical Assistant
Other areas of specialty/work
Street address
Kosar Medical Education Center,Taleghani Street,Qazvin
City
Qazvin
Postal code
Phone
+98 28 3323 6375
Fax
Email
Mon_470@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)