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RECRUITING
NCT07264309
NA

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

Sponsor: Zohar Nachum

View on ClinicalTrials.gov

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

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

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-11-01

Completion Date

2027-12

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

DRUG

pethidine

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

DRUG

Tramadol

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

DRUG

Paracetamol 1 g

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

Locations (1)

HaEmek MC

Afula, Israel