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

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

Study Overview

• Status: Recruiting
• Conditions: Pain Management; Birth
• Intervention / Treatment: Drug: pethidine; Drug: Tramadol; Drug: Paracetamol 1 g

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zohar Nachum, Prof.; Phone Number: +972-547696562; Email: nachum_zo@clalit.org.il

Study Locations

• Israel
  • Afula, Israel
    • Recruiting
    • HaEmek MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pethidine; 75 mg of pethidine will be given intramuscularly in the upper - outer quadrant of the	Drug: pethidine; 75 mg of pethidine will be given intramuscularly in the upper - outer quadrant of the
Experimental: Combination of paracetamol and tramadol; Women will receive intravenous infusion of 50 ml contain 1000mg paracetamol and 100ml contain 100mg tramadol over 15 min	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Pregnancy outcomes	from birth up to 72 hours after birth

Collaborators and Investigators

• Sponsor: Zohar Nachum

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lipids; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Piperidines; Alcohols; Acids, Heterocyclic; Cyclohexanols; Hexanols; Fatty Alcohols; Dimethylamines; Methylamines; Isonipecotic Acids; Acetaminophen; Meperidine; Tramadol
• Other Study ID Numbers: 37-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No