A study to comparing Intravenous Paracetamol Combined with an Electric Heating Pad versus Fentanyl for Pain Relief during the First Stage of Labor, A Randomized Controlled Trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260407002

Enrollment

Registered

2026-04-07

Start date

2025-09-15

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

Term singleton pregnancy with labor pain during cervical dilation 4 to 6 cm Labor pain Active phase Paracetamol Fentanyl Thermal pad

Interventions

Participants will receive intravenous paracetamol 1,000 mg infused over at least 15 minutes combined with an active electric heating pad applied to the lower back or abdomen at a temperature of 40 to

Experimental Drug,Active Comparator Drug

Paracetamol IV + thermal pad,Fentanyl IV + dummy pad

Eligibility

Sex/Gender

Female

Age

20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Thai singleton-pregnant women aged 20 to 40 years 2.Gestational age 37 to 42 weeks 3.Active labor with cervical dilatation of 4 to 6 cm 4.No history of previous cesarean section or uterine surgery

Exclusion criteria

Exclusion criteria: 1.History of chronic pain 2.Baseline Visual Analogue Scale (VAS) score less than 4 3.Cephalopelvic disproportion (CPD) or contracted pelvis (diagonal conjugate less than 11.5 cm or interspinous diameter less than 8 cm) 4.Contraindication to vaginal delivery or obstetric emergency requiring immediate intervention 5.Known fetal anomaly 6.Maternal body weight less than 50 kg at labor 7.Pre-pregnancy BMI less than 18.5 or more than 24.9 kg per m2 8.Contraindication or allergy to paracetamol fentanyl or electric heating pad 9.Refusal to participate in the study

Design outcomes

Primary

Measure	Time frame
Pain at 1 hour and 2 hours after intervention during the first stage of labor Visual Analogue Scale (VAS)	—

Secondary

Measure	Time frame
Change in pain score at 0, 1 and 2 hours after intervention. Difference between VAS,Maternal adverse effects (nausea, vomiting, dizziness, drowsiness, pruritus, allergic reactions) During labor and until delivery Clinical observation and medical record documentation,Neonatal condition 1 minute and 5 minutes after birth Apgar score assessment,Neonatal complications (NICU admission, respiratory distress, cyanosis) After birth until hospital discharge Clinical assessment and medical record review,Mode of delivery At delivery Clinical record (vaginal delivery or cesarean section)	—

Measure

Time frame

Change in pain score at 0, 1 and 2 hours after intervention. Difference between VAS,Maternal adverse effects (nausea, vomiting, dizziness, drowsiness, pruritus, allergic reactions) During labor and until delivery Clinical observation and medical record documentation,Neonatal condition 1 minute and 5 minutes after birth Apgar score assessment,Neonatal complications (NICU admission, respiratory distress, cyanosis) After birth until hospital discharge Clinical assessment and medical record review,Mode of delivery At delivery Clinical record (vaginal delivery or cesarean section)

—

Countries

Thailand

Contacts

Public ContactHathaipat Klomsakul

Department of Obstetrics and Gynecology, Police General Hospital, Bangkok, Thailand

hathaipat.klom@gmail.com0856338184

Outcome results

None listed

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