Health TrialsbyHealthPanel

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

ConditionsPain ManagementBirth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorZohar Nachum

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Previous cesarean delivery

Malpresentation

Multiple pregnancies

Suspected intrauterine growth restriction < 3 percentile

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Combination of paracetamol and tramadolExperimental treatment 2 interventions
Group B: PethidineActive comparator 1 intervention

Trial outcomes

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.

Time frame
one hour after drug administration.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zohar Nachum

Lead sponsor

HaEmek Medical Center, Israel

Sponsor institution

Source ClinicalTrials.gov
Apply now