| CTRI Number |
CTRI/2023/09/057683 [Registered on: 15/09/2023] Trial Registered Prospectively |
| Last Modified On: |
14/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To study the efficacy and safety of injectable paracetamol with injectable tramadol in labor |
|
Scientific Title of Study
|
Comparative Study Of Safety And Efficacy Of Intravenous Paracetamol Versus Intramuscular Tramadol As Labour Analgesic |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SONICA RAI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OG OBG
SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES
SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES GANGTOK PINCODE 737102
East
SIKKIM
737102
India |
| Phone |
8389045088 |
| Fax |
|
| Email |
DRSONICARAI@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PESONA GRACE LUCKSOM |
| Designation |
PROFESSOR |
| Affiliation |
SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES |
| Address |
SMIMS ,DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES GANTOK PINCODE 737102
East
SIKKIM
737102
India |
| Phone |
9831195957 |
| Fax |
|
| Email |
pesona.l@smims.smu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR PESONA GRACE LUCKSOM |
| Designation |
PROFESSOR |
| Affiliation |
SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES |
| Address |
SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES
Department of OBG
5TH MILE TADONG
SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES GANTOK
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY 5TH MILE TADONG
East
SIKKIM
737102
India |
| Phone |
9831195957 |
| Fax |
|
| Email |
pesona.l@smims.sum.edu.in |
|
|
Source of Monetary or Material Support
|
| SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES, 5TH MILE TADONG ,737102 EAST SIKKIM |
|
|
Primary Sponsor
|
| Name |
SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES |
| Address |
5TH MILE GANGTOK ,EAST SIKKIM |
| Type of Sponsor |
Private 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 |
| Dr Pesona grace lucksom |
Central Referral Hospital |
Department of obstetrics and gynaecology,5th mile tadong, Gangtok East Sikkim
East
SIKKIM |
9831195957
pesona.l@smims.smu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES INSTITUTION ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intramuscular tramadol |
100 ml of 1 gram inj paracetamol single dose given over 10 minutes
1)100mg of inj tramadol hydrochloride single dose IM given over 15 mins.
2)Visual Analogue scale (VAS) will be used to assess pain intensity and will be recorded in register. |
| Comparator Agent |
Intravenous paracetamol |
100 ml of 1 gram inj paracetamol single dose given over 10 minutes
1)100mg of inj tramadol hydrochloride single dose IM given over 1 mins.
2)Visual Analogue scale (VAS) will be used to assess pain intensity and will be recorded in register. |
| Intervention |
Intravenous paracetamol versus intramuscular tramadol |
100 ml of 1 gram inj paracetamol single dose given over 10 minutes
1)100mg of inj tramadol hydrochloride single dose IM given over 15 mins.
2)Visual Analogue scale (VAS) will be used to assess pain intensity and will be recorded in register. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Consenting women in early/active phase of labour at ≥37weeks gestation
Singleton pregnancy with cephalic presentation |
|
| ExclusionCriteria |
| Details |
Multiple Pregnancy and mal-presentation
Intrauterine fetal death
Women who do not consent for the study.
<37 weeks period of gestation
History of allergy to any of the study drugs |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check the efficacy of intravenous paracetamol with intramuscular tramadol when used as labor analgesics |
10 mins
30mins
1 hourly after the administration of drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check the safety of injection paracetamol with injection tramadol when used as labor analgesics |
0hrs to 24 hrs after delivery |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
23/09/2023 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All women in early/active labor after admission will be explained about the study and the type of drugs being used. Consenting pregnant women will be divided into two groups by alternate methods.
When the enrolled woman goes into active phase of labor with cervical dilatation ≥ 4cm,with cervical effacement of 60% ,she will be administered Visual Analogue Scale for pain scoring, then she will be given either one of the following study drugs: • 100 ml of 1 gram inj paracetamol single dose given over 10 minutes •100mg of inj tramadol hydrochloride single dose IM given over 15 mins. •Visual Analogue scale (VAS) will be used to assess pain intensity and will be recorded in register. •Pain in both groups will be analyzed at 10 mins, 30 mins and then hourly after drug administration. If VAS >6 at any time, additional analgesic will be added . Labor will be monitored using a WHO modified partograph and termination of pregnancy will be as per standard.
Fetal monitoring will be done using a electronic fetal monitor. Mothers will monitored for 24 hours after delivery for any side-effects and Neonatal conditions will be assessed by the use of APGAR scoring system and the need for admission into the NICU |