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NCT Number: NCT07264309

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

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

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Key information

Conditions

Pain Management Agnosia Birth Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

HaEmek MC

Afula, Israel

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pethidine

Drug

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

Tramadol

Drug

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

Paracetamol 1 g

Drug

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

Primary outcomes

  1. The effect on pain relief

    Time frame: one hour after drug administration.

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

Secondary outcomes

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

    Time frame: from enrollment up to 72 hours after the birth

  2. Maternal adverse effects of the medications

    Time frame: from enrollment to 72 hours after birth

  3. First stage of labor duration (hours)

    Time frame: from enrollment to 72 hours after birth

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

    Time frame: from enrollment to 72 hours after birth

  5. Fetal and neonatal outcomes

    Time frame: from enrollment to 72 hours after birth

  6. Pregnancy outcomes

    Time frame: from birth up to 72 hours after birth

Study contacts

Contact information is provided by the study sponsor or research team.

Zohar Nachum, Prof.

CONTACT

[email protected]

+972-547696562

Sponsors and collaborators

Lead sponsor

Zohar Nachum

Other

Registry information

Official study title

Combined Intravenous Tramadol and Paracetamol Versus Intramuscular Pethidine for Pain Relief During the First Stage of Labor

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 4, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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