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

Completed

Conditions: Encounter for full-term uncomplicated delivery,

Registration Number: CTRI/2022/07/044230

Lead Sponsor: Dr Priyanka Bhuvanendran

Brief Summary: the study is used for comparing which drug among paracetamol and tramadol , is better during labour for pain relief and smooth delivery of the baby without much fetal distress and economically feasible

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 220

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
If paracetamol proves to be a better and safe analgesic than tramadol.	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
it can be used regularly as a safe labour analgesic	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 Outcome Measures

Name	Time	Method
fetal outcome after the administration of injection tramadol and paracetamol as labor analgesia	Apgar score at 1 minute and 5 minute and followed by babies observation for any distress for next 4 hours

Trial Locations

Locations (1): Shri B M Patil Medical College
🇮🇳
Bijapur, KARNATAKA, India
Shri B M Patil Medical College
🇮🇳Bijapur, KARNATAKA, India
DR PRIYANKA BHUVANENDRAN
Principal investigator
9606415233
drpriyanka.jb@gmail.com