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painless delivery

Comparison of intravenous Paracetamol versus intravenous Tramadol for analgesia in labour

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/014020
Enrollment
250
Registered
2018-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Pregnant women in active stage of labour

Interventions

Intervention1: Paracetamol: single dose of 100 ml of 1000 mg Paracetamol will be given intravenously over 15 min during active stage of labour Control Intervention1: Tramadol: single dose of 100 mg Tr

Sponsors

BPS Government medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Primigravid and multigravid women of age ranges from 18 to 35 years with low risk to both mother and fetus (single live fetus in cephalic presentation without any associated obstetric and medical complication) 2. Women with gestational age ranges from 37 to 42 weeks 3. Women in active stage of labour (with cervical dilatation of 3-5 cm and with moderate intensity uterine contractions of 2-3 per 10 minutes each lasting for 30-45 seconds with good inter relaxation period in between), whether spontaneous or induced labour 4. Women with reactive Non Stress Test (NST) before recruitment into study 5. Women seeking labour analgesia

Exclusion criteria

Exclusion criteria: 1. Women with high risk pregnancy like severe Intrauterine growth retardation (IUGR), multiple gestation, malpresentation, polyhydroamnios, oligohydroamnios, pre-mature rupture of membranes 2. Women with any medical disorder with pregnancy like severe anaemia, hypertensive disorders, diabetes mellitus, hypothyroidism 3. Women with scarred uterus 4. Women with obstetric indication for Lower Segment Caesarean Section before recruitment to study 5. Women in advanced stage of labour if cervical dilatation more than 5 cm 6. Women with use of any other kind of analgesia before recruitment to study 7. Women with previous history of hypersensitivity to Tramadol or Paracetamol 8. Women with deranged liver function test 9. Women not willing to participate in study

Design outcomes

Primary

MeasureTime frame
VISUAL ANALOGUE SCALE scoreTimepoint: At 0, 1/2, 1, 2 and 4 hours

Secondary

MeasureTime frame
APGAR SCORETimepoint: At 1 and 5 minutes;Demographic Profile of patientsTimepoint: At 0 hour;Duration of active phase of labourTimepoint: After delivery;Duration of labour analgesiaTimepoint: At 0, 1/2, 1, 2 and 4 hours;Effect on fetus during labourTimepoint: At 0, 1/2, 1, 2 and 4 hours;Effect on progress of labourTimepoint: At 0, 1/2, 1, 2 and 4 hours;Mode of deliveryTimepoint: After delivery

Countries

India

Contacts

Public ContactEKTA SIDHU

Bhagat Phool Singh Government Medical College for Women

siwachsunita@ymail.com9812266400

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026