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Comparison of subcutaneous fentanyl 25 micrograms versus 50 micrograms for labor pain relief: A randomized controlled trial

Comparison of subcutaneous fentanyl 25 micrograms versus 50 micrograms for labor pain relief: A randomized controlled trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251027003
Enrollment
100
Registered
2025-10-27
Start date
2025-09-19
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

Women in active labor experiencing labor pain during childbirth Labor Pain

Interventions

Fentanyl 25 mcg sc,Fentanyl 50 sc
Experimental Drug,Experimental Drug

Sponsors

Khonkaen hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1 Pregnant women aged more than 18 years 2 Gestational age between 37 and 41 weeks and 6 days 3 Planned vaginal delivery 4 Viable single fetus with cephalic presentation 5 Require labor analgesia with visual analogue scale pain score of 4 or higher out of 10 6 Cervical dilatation between 4 and 9 centimeters

Exclusion criteria

Exclusion criteria: 1 Presence of fetal anomaly 2 Received pethidine or fentanyl within the previous 24 hours 3 Presence of obstetric or medical conditions during pregnancy, including: Pre-eclampsia Severe bronchial asthma History of seizure or head injury Glaucoma Active heart disease Active liver disease Diabetes requiring medication Phaeochromocytoma 4 Known allergy or hypersensitivity to opioids, presenting as: Dyspnea Bronchospasm Hypotension Generalized urticaria Angioedema Requirement for adrenaline for resuscitation 5 Inability to understand the Thai language 6 Use of substances or antidepressant medications within the previous 14 days 7 Intellectual disability

Design outcomes

Primary

MeasureTime frame
pain score at 15 mins after fentanyl administration using the Visual Analogue Scale (VAS) 0-10 15 mins after fentanyl administration VAS

Secondary

MeasureTime frame
Maternal outcomes: pain score every hour until delivery, additional fentanyl doses, mode of delivery, adverse effects and satisfaction 60 mins after fentanyl administration and 2 hour after delivery VAS and a 5-point Likert scale ,Neonatal outcomes: intrapartum fetal monitoring, Apgar score, administration of naloxone, etc 30 mins after fentanyl administration and after delivery intrapartum fetal monitoring, Apgar score, administration of naloxone

Countries

Thailand

Contacts

Public ContactPittawat Srihawong

Khonkaen hospital

pittawat_s@kkumail.com043009900

Outcome results

None listed

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