Actively Recruiting
Combined Intravenous Tramadol and Paracetamol Versus Intramuscular Pethidine for Pain Relief During the First Stage of Labor. Compare the Efficacy and Adverse Effects
Led by Zohar Nachum · Updated on 2025-12-15
140
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this intervention study is to compare the efficacy and adverse effects of pain relief during the first stage of labor using 75 mg IM pethidine versus the combination of IV 100 mg tramadol and 1000 mg paracetamol. The investigator assume that the combination of IV tramadol and paracetamol will be more effective with less adverse effects than IM pethidine in pain relief at the first stage of labor. The investigator primary outcome is The effect on pain relief according to numeric rating scale (NTS) in the study groups Before the administration of the drugs, fetal heart rate patterns and contractions will be recorded with cardiotocography monitor for at least 20 min. The investigator will evaluate vigilance at 30 minutes following drug administration. NRS pain score (0-10) will be collected before administration and one hour after drug administration
CONDITIONS
Official Title
Combined Intravenous Tramadol and Paracetamol Versus Intramuscular Pethidine for Pain Relief During the First Stage of Labor. Compare the Efficacy and Adverse Effects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Singleton term pregnancy
- First stage of labor with at least 4 painful contractions in 30 minutes
- Cervical dilation less than or equal to 1 cm or 50% effacement
- Spontaneous or induced labor
You will not qualify if you...
- Previous cesarean delivery
- Malpresentation
- Multiple pregnancies
- Suspected intrauterine growth restriction less than 3 percentile
- Suspected placental abruption
- Allergy to paracetamol, tramadol, or pethidine
- Sleep apnea disorder
- Morbid obesity with BMI of 40 or higher
- Significant cardiac, liver, or renal diseases
- Use of anti-convulsive medication
- Use of MAO inhibitors within the last 14 days
- Non-reassuring fetal heart rate monitoring (type II or III)
- Tense use
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
HaEmek MC
Afula, Israel
Actively Recruiting
Research Team
Z
Zohar Nachum, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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