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A Comparison of Two Low-Dose Regimens of Intravenous Fentanyl for Pain Relief during Labor

A Comparison of Two Low-Dose Regimens of Intravenous Fentanyl for Pain Relief during Labor: A Double Blinded, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230530005
Enrollment
100
Registered
2023-05-30
Start date
2023-06-16
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

pregnancy in active phase of first stage of labor who requested analgesia. labor pain fentanyl analgesia pain score

Interventions

o 1 ml of 50 micrograms fentanyl will be diluted in 3 ml normal saline (total volume 4 ml/50 mcg), 2 ml of drug solution will be slowly pus via intravenous for 1-2 minutes. o and additional intraveno
Active Comparator Drug,Active Comparator Drug

Sponsors

Khon Kaen hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. age 18 years or older 2. prefer not using an epidural 3. term pregnancy (37-42 weeks of gestation) 4. plan a vaginal birth 5. has a viable single fetus 6. with vertex presentation 7. no known psychological disorders 8. cervical dilatation of at 5-8 cm 9. visual analogue scale at least 4

Exclusion criteria

Exclusion criteria: 1. had received opioid such as pethidine or fentanyl within previous 24 hours 2. maternal respiratory rate less than 10 or maternal bradycardia (pulse rate less than 60) or oxygen saturation less than 95% 3. were diagnosed with conditions (a) severe bronchial asthma (b) Glaucoma (c) heart or liver problems (d) allergy or previous adverse reaction to opioids (such as fentanyl or pethidine) (e) opioid substances dependency in last year (f) taken antidepressants within the previous 14 days (g) cognitive impairments or had an intellectual disability.

Design outcomes

Primary

MeasureTime frame
pain score after 30 minutes visual analogue scales

Secondary

MeasureTime frame
pulse rate, respiratory rate, MAP, Oxygen saturation after 30 minutes vital sign monitoring,sedative score after 30 minutes sedative score,total dose after last dose count,abnormal EFM 20 minutes after medication EFM,apgar score at 5 min 5 minutes after birth count,NICU admission after birth count,difficulties in astablishing breastfeeding 2 hours after birth Infant Breastfeeding Assessment Tool,Naloxone treatment at birth count,Satisfaction-would use treatment again after give birth Questionaire

Countries

Thailand

Contacts

Public ContactVeeraphol Srinil

Khon Kaen Hospital

s.srinil88@gmail.com043009900

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026