Ireland
--:--IST
Latest
Clinical Trials in Israel / NCT07264309
Recruiting Not applicable

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

NCT07264309 · tracked via the Priya Life Science Israel tracker
Sponsor
Zohar Nachum
Phase
Not applicable
Started
2025-11-01
Last updated
2025-12-15

Condition(s) studied

Pain ManagementBirth

Investigational drug(s) / intervention(s)

pethidine →Tramadol →Paracetamol 1 g →

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

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

Paracetamol 1 g: women will receive 50 ml containing 1000 mg of paracetamol IV over 15 min

Study 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
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: Singleton Term pregnancy First stage of labor including at least 4 painful contractions in 30 min with cervical dilatation less or equal to 1 cm or 50% effacement Spontaneous or induced labor - Exclusion Criteria: * Previous cesarean delivery * Malpresentation * Multiple pregnancies * Suspected intrauterine growth restriction \< 3 percentile * Suspected placental abruption * History of allergy to paracetamol, tramadol or pethidine * Women with sleep apnea disorder * Morbid obesity BMI≥40 * History of significant cardiac, liver and renal diseases * Anti-convulsive medication consumption * MAO inhibitors medication consumption within the last 14 days * Non reassuring fetal heart rate monitoring (type II or III) * Tense use

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
HaEmek MC Afula Israel Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07264309 on ClinicalTrials.gov ↗ ← All trials in Israel