RecruitingNot ApplicableNCT07264309

Combined Intravenous Tramadol and Paracetamol Versus Intramuscular Pethidine for Pain Relief During the First Stage of Labor. Compare the Efficacy and Adverse Effects

Combined Intravenous Tramadol and Paracetamol Versus Intramuscular Pethidine for Pain Relief During the First Stage of Labor


Sponsor

Zohar Nachum

Enrollment

140 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Paracetamol 1 g, a drug called Tramadol, and others for people with birth and pain management. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGpethidine

75 mg of pethidine will be given intramuscularly in the upper - outer quadrant of the

DRUGTramadol

Women will receive intravenous infusion of 100 ml containing 100 mg of tramadol over 15 min

DRUGParacetamol 1 g

women will receive 50 ml containing 1000 mg of paracetamol IV over 15 min


Locations(1)

HaEmek MC

Afula, Israel

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NCT07264309


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