CTRI Number |
CTRI/2022/08/045029 [Registered on: 29/08/2022] Trial Registered Prospectively |
Last Modified On: |
28/08/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A scientific research to be conducted among women in labour to reduce labour pain using either of the two injections |
Scientific Title of Study
|
A randomized controlled trial comparing Intravenous Paracetamol infusion versus Intramuscular Tramadol as an intrapartum labour analgesic in a tertiary care hospital |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Elamathi T |
Designation |
1st year post graduate in Department of Obstetrics and Gynecology |
Affiliation |
Indira Gandhi Medical College and Research Institute |
Address |
33, Iyyanar kovil street
Thattanchavady
Kathirkamam
Puducherrry Pondicherry PONDICHERRY 605009 India |
Phone |
9003952684 |
Fax |
|
Email |
elamathiteva@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ananathi K |
Designation |
Professor in Department of Obstetrics and Gynecology |
Affiliation |
Indira Gandhi Medical College and Research Institute |
Address |
Indra Gandhi Medical college and research institute
Kathirkamam
Puducherrry Pondicherry PONDICHERRY 605009 India |
Phone |
9442882958 |
Fax |
|
Email |
ananthiray@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Elamathi T |
Designation |
1st year post graduate in Department of Obstetrics and Gynecology |
Affiliation |
Indira Gandhi Medical College and Research Institute |
Address |
33, Iyyanar kovil street
Thattanchavady
Kathirkamam
Puducherrry Pondicherry PONDICHERRY 605009 India |
Phone |
9003952684 |
Fax |
|
Email |
elamathiteva@gmail.com |
|
Source of Monetary or Material Support
|
Indira Gandhi Medical College and Research Institute Puducherry 605 009 |
|
Primary Sponsor
|
Name |
Indira Gandhi Medical college and Research Institute |
Address |
Indira Gandhi Medical college and Research Institute
Kathirkamam
Puducherry |
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 |
Elamathi T |
Indira Gandhi Medical College and Research Institute in the Department of Obg in Labour ward |
Kathirkamam
Puducherry Pondicherry PONDICHERRY |
9003952684
elamathiteva@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Pregnant women |
Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
intramuscular Tramadol 50 mg |
injection Tramadol 50 mg tramadol will be administered intramuscular, in the upper outer quadrant of the gluteal region will be administered as 1st dose if patient requires a second dose will be administered after 5 hours of 1st dose with Visual analogue score of 6 or more |
Intervention |
intravenous Paracetamol 1000 mg in 100 ml solution |
intravenous infusion of 1000 mg paracetamol in 100 ml solution over 15 min using a standard gravity‑dependent IV infusion set, in which each 16 drops give 1 ml (infusion rate about 130 drops/min) will be administered as 1st dose if patient requires a second dose will be administered after 5 hours of 1st dose with Visual analogue score of 6 or more |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
35.00 Year(s) |
Gender |
Female |
Details |
Antenatal women in labour with cervical dilatation 3cm
Term gestation
Spontaneous onset of labour
Singleton pregnancy with vertex presentation
|
|
ExclusionCriteria |
Details |
Women with cephalopelvic disproportion
Previously scarred uterus (post myomectomy, post cesarean)
History of any drug allergy
Medical disorders complicating pregnancy like severe anemia, gestational diabetes mellitus, cardiac disease, pregnancy induced hypertension, pre-existing liver disorders, seizure disorders.
Non-reassuring NST
Intrauterine growth restriction (IUGR)
Intrauterine foetal death
Patients on antidepressants (e.g. SSRI)
Patients who are not willing to participate
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Pain relief as noted in the visual analogue score |
baseline, 1 h, 3 hrs and 5 hrs drug administration |
|
Secondary Outcome
|
Outcome |
TimePoints |
Interval between drug administration and delivery |
time of delivery |
|
Target Sample Size
|
Total Sample Size="152" Sample Size from India="152"
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
|
N/A |
Date of First Enrollment (India)
|
01/09/2022 |
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
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
The study will commence after obtaining IRC & IEC approval. It is a randomized controlled trial done over a period of 18 months among 152 pregnant women in spontaneous labour in the department of Obstetrics & Gynecology at IGMC&RI. This study will compare the efficacy of intravenous Paracetamol Versus Intramuscular tramadol to alleviate labour pain in pregnant women. Details of the study will be explained to the participants and informed written consent will be obtained from them.
A simple random sampling method will be used in this study to recruit the subjects. Patients are assigned to either of the two groups by balloting. Two sets of 76 opaque envelopes containing piece of paper labelled as A or B will be prepared and mixed thoroughly and placed in a box in the labor ward. An envelope will be picked up by each consecutive patient who consented and fulfilled the inclusion criteria. Antenatal women in spontaneous labour at 3cm cervical dilatation, satisfying the inclusion criteria are recruited after obtaining consent. Visual Analogue scale (VAS) will be used to assess pain intensity. The initial pain perception is assessed at 3 cm cervical dilatation using the VAS, then patients are randomised into two groups A and B. For patients in Group A -50 mg of tramadol will be administered intramuscularly, in the upper outer quadrant of the gluteal region. For patients in Group B, an IV infusion of 1000 mg paracetamol in 100 ml solution over 15 min using a standard gravity’ dependent IV infusion set, in which each 16 drops give 1 ml (infusion rate about 130 drops/min) will be administered . The severity of labour pain will be assessed subsequently at 1 hour, 3 hours and 5 hours after drug administration, in both groups using VAS and the score is recorded in number grading scale. The progression of labour will be monitored using WHO Partogram and standard institutional protocol will be followed for conducting delivery. A second or rescue dose will be administered for patients in both the groups after 5 hours of initial drug administration, if pain relief is inadequate, that is, a numerical rating of 6 and above on VAS, and this is recorded. The expected outcome is that intravenous Paracetamol is expected to have better analgesic efficacy, shorter duration of labour and fewer side-effects, when compared to intramuscular Tramadol, during labour. Hence in low resource settings, intravenous Paracetamol maybe used to provide labour analgesia. |