| CTRI Number |
CTRI/2018/06/014589 [Registered on: 20/06/2018] Trial Registered Retrospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
which is more effective labour pain reliever paracetamol or tramadol |
|
Scientific Title of Study
|
Efficacy and safety of intravenous paracetamol versus intramuscular tramadol hydrochloride as intrapartum analgesic: a randomised controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rana Mondal |
| Designation |
1st year Junior resident |
| Affiliation |
N.R.S Medical college and hospital kolkata |
| Address |
Labour Room, Department of obstetrics and Gynaecology
Room No.23 NHQ Hostel, N.R.S.M.C.H
Kolkata
WEST BENGAL
700037
India |
| Phone |
8777630801 |
| Fax |
|
| Email |
mondalrana099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Picklu Chaudhuri |
| Designation |
Associate Professor |
| Affiliation |
N.R.S Medical college and hospital kolkata |
| Address |
Department of Obstetrics and Gynaecology, N R S Medical college
Kolkata
WEST BENGAL
700014
India |
| Phone |
8777630801 |
| Fax |
|
| Email |
pickluchaudhuri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rana Mondal |
| Designation |
1st year Junior resident |
| Affiliation |
N.R.S Medical college and hospital kolkata |
| Address |
Labour room, Department of Obstetrics and Gynaecology
Kolkata
WEST BENGAL
700037
India |
| Phone |
8777630801 |
| Fax |
|
| Email |
mondalrana099@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
government |
| Address |
137, AJC Bose Road Kolkata |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rana Mondal |
NRS Medical college and Hospital |
Labour room , Department of obstetrics and Gynaecology
Kolkata
WEST BENGAL |
8777630801
mondalrana099@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee,NRS Medical College, kolkata |
Approved |
| Institutional Ethical committee,NRS Medical College, kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Healthy primigravida mothers of age 18 to 35 years without any comorbidities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Efficacy and safety of intravenous paracetamol versus intramuscular tramadol hydrochloride |
total 200 cases of eligible and consenting women willing to participate in study will be randomized using computers generated random number chart and opaque sealed envelops in 1:1 ratio in 2 groups. Women in group 1 will be given paracetamol infusion intravenously and women in group 2 will receive injection tramadol (100) inmtramuscularly. The randmization, group allocation and drug administration done by labour nurse and data related to this will be kept confidential so that investigators will be blinded. Labour pain will be monitored using VAS scale . Measurment of pain relief will be done with visual analogue pain intensity scale after 1,2 and 4 hours of drug administration. Duration of labour ,mode of delivery , neonatal outcome, drug administration to delivery interval, side effects of drug in both groups will be noted. Any major complications in the mother and fetus will be recorded. |
| Comparator Agent |
Intramuscular Tramadol hydrochloride 100mg i.m. |
all the women in tramadol group will be given trmadol hydrochloride 100mg intrmuscular single dose in upper and outer quadrant of gluteal region with a 2ml syringe. |
| Comparator Agent |
Intravenous paracetamol infusion 1g i.v.
|
total 200 cases of eligible and consenting women willing to participate in study will be randomized using computers generated random number chart and opaque sealed envelops in 1:1 ratio in 2 groups. Women in group 1 will be given paracetamol infusion intravenously and women in group 2 will receive injection tramadol (100) inmtramuscularly. The randmization, group allocation and drug administration done by labour nurse and data related to this will be kept confidential so that investigators will be blinded.
all women in paracetamol group will receive 100ml of infusion containing 1000mg paracetamol single dose over 15 min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Primigravidae in spontaneous labour
2. Active phase of labour (cervical dilation of ≥4cm,in the presence of adequate uterine 3 contractions per 10 minutes and each lasting at least for 40 seconds)
3. Maternal age between 18 to 35 years
4. Singleton term pregnancy(37 - 42 weeks of gestation)
5. vertex- presenting fetus |
|
| ExclusionCriteria |
| Details |
1. clinical evidence of cephalopelvic disproportion
2. Malpresentation
3. scrred uterus , previous cesarean section, hysterotomy or myomectomy
4.medical disorders associated with pregnancy, especially severe anemia, jaundice, hypertension,diabetes, renal impairment
5. Fetal distress
6. Receiving any regional or parenteral analgesia before recuitment in the study.
7. Known hypersensitoivity to the drug family
8. induced labour |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Subjective assessment of intrapartum labour pain accordance to visual analouge scale |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. duration of labour
2. mode of delivery
3. Maternal adverse effect like nausea, vomitting, respiratory distress, post partum hemorrhage and any other specific adverse effect
4. Fetal adverse effect: APGAR score at 1 and 5 min. , number of neonate requiring admission in NICU |
February 2018 to February 2019 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 1 |
|
Date of First Enrollment (India)
|
01/02/2018 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
none yet thought for publication in any specific journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The objective of the study is to compare intravenous paracetamol and intramuscular tramadol as a intrapartum analgesic in terms of reduction of pain according to visual analogue scale ,duration of labour and mode of delivery, maternal side effects intrapartum and postpartum period, fetal APGAR score at 1 min and 5 min number of cases admitted in NICU, fetal hyperbilirubinimia, and any other specific neonatal adverse effects. We expect our study to prove intravenous paracetamol is more effective intrapartum labour analgesic with fewer maternal and fetal side effects as compared to intramuscular tramadol. |