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

Zohar Nachum

Status: Enrolling

Conditions: Birth; Pain Management

Treatments: Drug: Tramadol; Drug: Paracetamol 1 g; Drug: pethidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07264309

37-24

Details and patient eligibility

About

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

Enrollment: 140 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

Combination of paracetamol and tramadol

Experimental group

Description:

Women will receive intravenous infusion of 50 ml contain 1000mg paracetamol and 100ml contain 100mg tramadol over 15 min

Treatment:

Drug: Paracetamol 1 g

Drug: Tramadol

Pethidine

Active Comparator group

Description:

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

Treatment:

Drug: pethidine