Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain

Labor Pain Clinical Trial

Official title:

Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain in a Low Resource Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04744727
• Other study ID #: 11/2019OBSGN/27
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: May 10, 2020

Study information

• Verified date: February 2021
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• paracetamol-pethidine
100 ml containing 1000 mg paracetamol -50 mg pethidine HCL

Locations

Country	Name	City	State
Egypt	Menoufia University hospital	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	immediately after the intervention and up to 3 hours after the intervension
Secondary	duration of the active phase of the 1st stage of labor		immediately from start of active phase of the 1st stage of labor till the end of first stage
Secondary	duration of the 2nd stage of labor		immediately from start of second stage till deliver of fetus
Secondary	need for further analgesia		immediately after the intervention till the end of first stage of labour
Secondary	maternal dizziness, nausea and/or vomiting		immediately after the intervention till the end of first stage
Secondary	mode of delivery (vaginal or by caesarian		immediately after the intervention
Secondary	1- and 5-minutes Apgar scores.		immediately after delivery of the fetus
Secondary	need for neonatal resuscitation		immediately after delivery of the fetus
Secondary	need for NICU admission		immediately after delivery of the fetus
Secondary	Neonatal respiratory distress .		immediately after delivery of the fetus