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A comparison study to understand which is better between injection paracetamol and injection tramadol as anaesthetic agent to reduce pain during delivery

A Randomised Controlled Trial To Compare The Efficacy Of Intravenous Paracetamol And Intramuscular Tramadol As Labor Analgesic

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044230
Enrollment
220
Registered
2022-07-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Control Intervention1: paracetamol and tramadol: comparison between injection paracetamol 1000mg intravenous and injection tramadol intra muscular 1 ampule 100mg stat dose after 4 cm of cervical di

Sponsors

Dr Priyanka Bhuvanendran
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: primigravida with period of gestation >37 weeks with vertex presentation in active labour with cervical dilatation of >4cm , with cervical effacement >60% with singleton pregnancy

Exclusion criteria

Exclusion criteria: women with clinical evidence of cephalopelvic disproportion , multiparous , malpresentation , multiple pregnancies , previously scarred uterus , preterm labour , induced labour , antepartum haemorrhage , preeclampsia , history of drug allergies , history of medical disorders like cardiac , renal , liver diseases , intrauterine foetal demise , history of cervical incompetence , oligohydramnios , fetal growth restrictions , congenital anomalies in the foetus , cervical dilatation > 6 cm

Design outcomes

Primary

MeasureTime frame
If paracetamol proves to be a better and safe analgesic than tramadol. it can be used regularly as a safe labour analgesicTimepoint: labour pain assessed after giving paracetamol or tramadol during labour at 0 hour , 1 hour , 3 hour , 2nd stage of labour , 1 hour after delivery

Secondary

MeasureTime frame
fetal outcome after the administration of injection tramadol and paracetamol as labor analgesiaTimepoint: Apgar score at 1 minute and 5 minute and followed by babies observation for any distress for next 4 hours

Countries

India

Contacts

Public ContactDr Neelamma Patil

SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE

neelamma.patil@bldedu.ac.in8106725928

Outcome results

None listed

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