Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain

Menoufia University

Status: Completed

Conditions: Labor Pain

Treatments: Drug: paracetamol-pethidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04744727

11/2019OBSGN/27

Details and patient eligibility

About

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

Full 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

Enrollment: 96 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

paracetamol group

Active Comparator group

Description:

Included 48 pregnant women who received 1000 mg of intravenous paracetamol. The treatment was administered at the begining of the active phase of 1st stage of labor \[roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%\].

Treatment:

Drug: paracetamol-pethidine

pethidine group

Active Comparator group

Description:

Included 48 pregnant women who received 50 mg of intravenous pethidine HCL diluted in 10 ml normal saline. The treatment was administered at the beginning of the active phase of 1st stage of labor \[roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%\].

Treatment:

Drug: paracetamol-pethidine