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

Phase 4
Recruiting
Conditions
pregnancy in active phase of first stage of labor who requested analgesia.
labor pain
fentanyl
analgesia
pain score
Registration Number
TCTR20230530005
Lead Sponsor
Khon Kaen hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Female
Target Recruitment
100
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
pain score after 30 minutes visual analogue scales
Secondary Outcome Measures
NameTimeMethod
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
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