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

NCT07264309 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-12-15

No results posted yet for this 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

Conditions

  • Pain Management
  • Birth

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

Sponsors & Collaborators

  • Zohar Nachum

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07264309 on ClinicalTrials.gov