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

NCT ID: NCT07264309

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-12-31

Brief 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

Conditions

Pain Management; Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination of paracetamol and tramadol

Women will receive intravenous infusion of 50 ml contain 1000mg paracetamol and 100ml contain 100mg tramadol over 15 min

Group Type: EXPERIMENTAL

Tramadol

Intervention Type: DRUG

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

Paracetamol 1 g

Intervention Type: DRUG

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

Pethidine

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

Group Type: ACTIVE_COMPARATOR

pethidine

Intervention Type: DRUG

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

Interventions

pethidine

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

Intervention Type: DRUG

Tramadol

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

Intervention Type: DRUG

Paracetamol 1 g

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

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zohar Nachum

OTHER

Sponsor Role: lead

Responsible Party

Zohar Nachum

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

HaEmek MC

Afula, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Zohar Nachum, Prof.

Role: CONTACT

nachum_zo@clalit.org.il

+972-547696562

Other Identifiers

37-24

Identifier Type: -

Identifier Source: org_study_id