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CTRI Number  CTRI/2020/06/025866 [Registered on: 15/06/2020] Trial Registered Prospectively
Last Modified On: 14/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two drugs paracetamol and tramadol in providing pain relief in labor pains 
Scientific Title of Study   Paracetamol versus tramadol intravenous infusion for labor analgesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sania Jindal 
Designation  Post Graduate Junior Resident 
Affiliation  Government medical college and hospital sector 32 chandigarh 
Address  Level 4 D-block Department of Obstetrics and Gynaecology Government medical college and hospital sector 32 Chandigarh CHANDIGARH 160030 India

Chandigarh
CHANDIGARH
160030
India 
Phone  8847481411  
Fax    
Email  saniajindal2708@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Poonam Goel 
Designation  Associate Professor 
Affiliation  Government medical college and hospital sector 32 chandigarh 
Address  Level 4 D-block Department of Obstetrics and Gynaecology Government medical college and hospital sector 32 Chandigarh CHANDIGARH 160030 India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121578  
Fax    
Email  poonam1302@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Sania Jindal 
Designation  Post Graduate Junior Resident 
Affiliation  Government medical college and hospital sector 32 chandigarh 
Address  Level 4 D-block Department of Obstetrics and Gynaecology Government medical college and hospital sector 32 Chandigarh CHANDIGARH 160030 India

Chandigarh
CHANDIGARH
160030
India 
Phone  8847481411  
Fax    
Email  saniajindal2708@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College and Hospital sector 32, Chandigarh.PIN 160030,INDIA 
 
Primary Sponsor  
Name  Government Medical College and Hospital Chandigarh 
Address  Government Medical College and Hospital sector 32, Chandigarh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sania Jindal  Labor room of Government Medical College and Hospital sector 32, Chandigarh  Level 1, A block,Clean Labor room, Area 15, Government Medical College and Hospital sector 32, Chandigarh CHANDIGARH
Chandigarh
CHANDIGARH 		 8847481411

saniajindal2708@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous infusion of Paracetamol for labor analgesia  Paracetamol also known as acetaminophen mediates its action by inhibiting prostaglandin synthesis,it inhibits the COX pathway in hypothalamus and also via serotonergic pathway.It is frequently used in obstetrics for providing labor analgesia alone or as an adjunct with other drugs.Paracetamol appears to be more efficacious with less negative effects on parturients and neonates.Paracetamol group will receive paracetamol infusion @5ml/min(1g of paracetamol diluted with 0.9% NS to make a total volume of 100ml,resulting in a concentration of 10mg/ml)which is given as infusion.The dose is 1ooomg given over a period of 20 minutes, given only once, but can be repeated one time after 3 hours if no pain relief is seen. 
Comparator Agent  Intravenous infusion of Tramadol for labor analgesia  Role of intravenous infusion of Tramadol for providing labor analgesia during the active phase of labor.Intravenous infusion of the study group will be started after assessing baseline Visual analogue score, according to randomly divided two groups. Tramadol is a weak opioid analgesic which interacts with u,delta and k opioid receptors, it exhibits purely agonist action. Tramadol group will receive tramadol infusion @5ml/min (1mg/Kg of tramadol diluted with 0.9% NS to make a total volume of 100 ml, upto a maximum of 100 mg tramadol) which is given as an infusion.Maximum dose of tramadol is 100 mg given over 20 mins only once, but can be repeated after 3 hours if no effect is seen. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Patients for intented vaginal delivery in
active phase of labor with cervical
dilatation from 4-6cm
2.Gestational age (37-41 weeks)
3.Spontaneous or induced Labor
4.Age (18-35 years)
5. Primigravida / Multigravida(upto parity 1)
6.Singlenton pregnancy with viable fetus
7.Vertex presentation
8.Patients not a candidate for neuraxial
analgesia for various reasons(not
willing/presence of contraindications,etc.)
9.Non scarred uterus
 
 
ExclusionCriteria 
Details  1.Medical disorder - Pregestational Diabetes
Mellitus, Rheumatic heart disease, chronic
hypertension,Severe anaemia, Liver disease ,
Renal disease and Epilepsy
2.Preclampsia ,Eclampsia
3.Gestational diabetes mellitus on insulin
therapy.
4.Use of any other kind of analgesia before
recruitment in study.
5.Non reassuring fetal heart rate
6.Antepartum haemorrhage
7.Polyhydramnios,Intrauterine growth
restriction
8.Chorioamnionitis
9.Hypersenstivity to paracetamol
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual analogue score assessment of labor analgesia  At start of giving drug, at 1 hour and 3 hours of drug adminstration 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of active phase of first stage of labor, duration of second stage of labor, fetal bradycardia, mode of delivery,respiratory depression in baby, neonatal apgar score,NICU admissions  From start of giving drug till the time of discharge from hospital 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   20/06/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a  prospective,randomized comparative study.It will compare the effect of paracetamol intravenous infusion with tramadol intravenous infusion in providing labor analgesia and maternal and fetal side effects.
Intravenous infusion of study drug will be started after assessing baseline Visual analogue score in active phase of labor in singelton pregnancy according to randomly divided two groups.
Paracetamol infusion in few studies done have shown to be safe and more efficacious than intravenous tramadol infusion  for  labor analgesia.It has no side effects of opioids like nausea, vomiting or sedation in the parturient and also safe for neonates.Paracetamol is also easily available, , affordable and easy to administer as tramadol.So, in this study we will compare the effect of  1g paracetamol and 1mg/Kg tramadol intravenous infusion  in providing labor analgesia.
 
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