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

NCT07264309 | Recruiting

• 1 other identifier: 37-24
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The effect on pain relief

  according to numeric rating scale (NRS), which runs from 0-10, where 0 is "no pain" and 10 is the "worst pain.

  one hour after drug administration.

Secondary Outcomes (6)

• Women satisfactory rate by NRS- a scale between 1-5, where 1 is no satisfactory and 5- is excellent satisfactory

  from enrollment up to 72 hours after the birth

• Maternal adverse effects of the medications

  from enrollment to 72 hours after birth

• First stage of labor duration (hours)

  from enrollment to 72 hours after birth

• The need for additional analgesia (Epidural, pethidine IV, nitrous)

  from enrollment to 72 hours after birth

• Fetal and neonatal outcomes

  from enrollment to 72 hours after birth

Study Arms (2)

Combination of paracetamol and tramadol

EXPERIMENTAL

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

Drug: Tramadol; Drug: Paracetamol 1 g

Pethidine

ACTIVE COMPARATOR

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

Drug: pethidine

Interventions

Tramadol DRUG

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

Combination of paracetamol and tramadol

Paracetamol 1 g DRUG

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

Combination of paracetamol and tramadol

pethidine DRUG

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

Pethidine

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Zohar Nachum: lead

Study Sites (1)

HaEmek MC

Afula, Israel

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Meperidine; Tramadol; Acetaminophen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds

Central Study Contacts

Zohar Nachum, Prof.

CONTACT

+972-547696562; nachum_zo@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)