Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain

Menoufia University96 enrolled

Overview

to compare between the use of single dose of paracetamol and pethidine hydrochloride intravenously in management of labour pains

investigators conducted a randomized clinical study included including 96 primiparous women admitted to Obstetrics and Gynecology Department, Menoufia University Hospitals, starting the study from May 2019 to March 2020 to assess the use of paracetamol intravenously versus Pethidine HCL intravenously in management of intrapartum pain. After obtaining approval from the local ethics committee, women who agreed to participate gave their signed informed consent after explanation of the trial benefits and hazards

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Labor Pain

Interventions

paracetamol-pethidineDRUG

100 ml containing 1000 mg paracetamol -50 mg pethidine HCL

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Primiparous * aged 18-35 years, * Term live singleton pregnancy, * Vertex presentation, * Spontaneous onset of labor at term 37-42 weeks gestation, * In active phase of of 1st stage of labour (cervix dilatation 3- 4 cm). Exclusion Criteria: Clinical evidence of cephalopelvic disproportion * Use of any kind of analgesia prior to study * Any medical disorder during pregnancy (liver or kidney impairment) * Induction of labor, Intrauterine fetal death * Evidence of fetal distress * Antenatal diagnosis of congenital malformation * Previous history of hypersensitivity to either drug * Extremes of age (i.e. below 18 or above 35) * Multiple pregnancies * Cervical dilatation more than 6 cm.

Locations (1)

Menoufia University hospital

Shibīn al Kawm, Menoufia, Egypt

Outcomes

Primary Outcomes

change of the intensity of perceived labor pain.

Labour pain was semi-objectively assessed using the visual analogue scale (VAS). In this technique, the patient is shown a ten cm line which represent at one end no pain and the other worst pain, and the patient is asked to point on the line where her pain lies. This scale has the added advantage that the pain can be given a numerical value.

Time frame: immediately after the intervention and up to 3 hours after the intervension

Secondary Outcomes

duration of the active phase of the 1st stage of labor

Time frame: immediately from start of active phase of the 1st stage of labor till the end of first stage

duration of the 2nd stage of labor

Time frame: immediately from start of second stage till deliver of fetus

need for further analgesia

Time frame: immediately after the intervention till the end of first stage of labour

maternal dizziness, nausea and/or vomiting

Time frame: immediately after the intervention till the end of first stage

mode of delivery (vaginal or by caesarian

Time frame: immediately after the intervention

1- and 5-minutes Apgar scores.

Time frame: immediately after delivery of the fetus

need for neonatal resuscitation

Time frame: immediately after delivery of the fetus

need for NICU admission

Time frame: immediately after delivery of the fetus

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.