Actively Recruiting
Combined Intravenous Tramadol and Paracetamol Versus Intramuscular Pethidine for Pain Relief During the First Stage of Labor
Led by Zohar Nachum · Updated on 2025-12-15
140
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two methods of pain relief during the first stage of labor in women with singleton pregnancies. The study evaluates the effectiveness and side effects of 75 mg intramuscular pethidine versus a combination of intravenous 100 mg tramadol and 1000 mg paracetamol. The aim is to see if the tramadol and paracetamol combination provides better pain relief with fewer adverse effects. Pain intensity will be measured using a numeric rating scale before and one hour after drug administration. Fetal heart rate patterns and contractions will be monitored using cardiotocography before treatment, and maternal alertness will be checked 30 minutes after drug administration. Participants will be randomly assigned to receive either an intravenous infusion of tramadol and paracetamol over 15 minutes or a single intramuscular injection of pethidine. The tramadol dose is 100 mg in 100 ml, and paracetamol is 1000 mg in 50 ml. The study does not involve blinding and compares these two active treatments directly. Follow-up assessments will continue up to 72 hours after birth to evaluate additional outcomes such as maternal satisfaction, adverse effects, duration of labor, need for extra pain relief, and fetal and neonatal health. During the study, women will have their pain ratings recorded before and after treatment, and fetal monitoring will be done prior to drug administration. Additional data will be collected throughout labor and for 72 hours postpartum to track safety and effectiveness measures. Researchers will assess maternal satisfaction with pain relief using a numeric rating scale from 1 to 5, monitor any side effects, and evaluate pregnancy outcomes. The total participation time extends from enrollment through the first three days after delivery.
CONDITIONS
Brief 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...
- Female with singleton term pregnancy
- In 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
- Labor may be spontaneous or induced
You will not qualify if you...
- Previous cesarean delivery
- Malpresentation of the fetus
- Multiple pregnancies
- Suspected intrauterine growth restriction below 3 percentile
- Suspected placental abruption
- Allergy to paracetamol, tramadol, or pethidine
- Sleep apnea disorder
- Morbid obesity with BMI 40 or higher
- Significant heart, liver, or kidney diseases
- Use of anti-convulsive medications
- 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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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - During the first stage of labor
Participants receive either a combined intravenous infusion of tramadol and paracetamol or an intramuscular injection of pethidine for pain relief during the first stage of labor.
1 treatment visit (in-person)
Duration - Up to 72 hours after birth
Participants are monitored for up to 72 hours after birth to assess pain relief satisfaction, adverse effects, labor duration, additional analgesia needs, and pregnancy and neonatal outcomes.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
HaEmek MC
Afula, Israel
Actively Recruiting
Research Team
Z
Zohar Nachum, Prof.
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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