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Efficacy of intravenous infusion Paracetamol versus intravenous pethidine during active phase of first stage of labor : open-label randomized controlled trial

Efficacy of intravenous infusion Paracetamol versus intravenous pethidine during active phase of first stage of labor : open-label randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260612009
Enrollment
102
Registered
2026-06-12
Start date
2026-04-17
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Active phase of first stage of labor in term pregnancy Paracetamol vs Pethidine

Interventions

Paracetamol 1000 mg IV drip in 15 minutes,Pethidine 50 mg IV stat
Experimental Drug,Active Comparator Drug
Paracetamol,Pethidine

Sponsors

Phramongkutklao hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Pregnant women aged 20 years or older. 2. No contraindications for vaginal delivery. 3. Planned delivery at gestational age 37 weeks or greater. 4. Willing to participate in the study and able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. History of allergy to paracetamol. 2. History of allergy to pethidine. 3. Presence of underlying medical conditions, including asthma, severe hepatic impairment, renal failure, heart disease, or G6PD deficiency. 4. History of substance abuse. 5. Presence of psychiatric disorders or inability to cooperate with pain assessment. 6. Indication for cesarean delivery. 7. Multiple pregnancy. 8. Fetus diagnosed with congenital anomalies that may impede vaginal delivery.

Design outcomes

Primary

MeasureTime frame
pain score 0,30,60 minutes numeric rating scores

Secondary

MeasureTime frame
Dizziness 60 minutes Yes/No,APGAR 1-10 score,NICU 1 day Yes/No,neonatal death 1 day Yes/No,Nausea/Vomiting 60 minutes Yes/No,Respiratory Distress 60 minutes Yes/No

Countries

Thailand

Contacts

Public ContactTatchamon Prasartintara

Phramongkutklao hospital

tatchamonpr@gmail.com0816403068

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026