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Recruiting NCT07264309

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

No phase Interventional Pain Management Birth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pethidine, Tramadol, Paracetamol 1 g.
Who it may be relevant to
Registry conditions: Pain Management, Birth. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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

Primary outcome measures

  • The effect on pain relief [Time frame: one hour after drug administration.]
Secondary outcome measures (6)
  • 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]
  • Maternal adverse effects of the medications [Time frame: from enrollment to 72 hours after birth]
  • First stage of labor duration (hours) [Time frame: from enrollment to 72 hours after birth]
  • The need for additional analgesia (Epidural, pethidine IV, nitrous) [Time frame: from enrollment to 72 hours after birth]
  • Fetal and neonatal outcomes [Time frame: from enrollment to 72 hours after birth]
  • Pregnancy outcomes [Time frame: from birth up to 72 hours after birth]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Israel · 1 center
  • HaEmek MC — Afula

Identifiers

NCT: NCT07264309 · 37-24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗