Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain

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

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

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Drug: paracetamol-pethidine

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt, 11111
      • Menoufia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: paracetamol group; 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%].	Drug: paracetamol-pethidine; 100 ml containing 1000 mg paracetamol -50 mg pethidine HCL
Active Comparator: pethidine group; 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%].	Drug: paracetamol-pethidine; 100 ml containing 1000 mg paracetamol -50 mg pethidine HCL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
duration of the 2nd stage of labor	immediately from start of second stage till deliver of fetus
need for further analgesia	immediately after the intervention till the end of first stage of labour
maternal dizziness, nausea and/or vomiting	immediately after the intervention till the end of first stage
mode of delivery (vaginal or by caesarian	immediately after the intervention
1- and 5-minutes Apgar scores.	immediately after delivery of the fetus
need for neonatal resuscitation	immediately after delivery of the fetus
need for NICU admission	immediately after delivery of the fetus
Neonatal respiratory distress .	immediately after delivery of the fetus

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Study Director: Mohamed Anter, Faculty of medicine-Menoufia university-shebin elkom -egypt

Publications and helpful links

General Publications

• Anter ME, Abdel Attey Saleh S, Shawkey Allam S, Mohamed Nofal A. Efficacy and safety of intravenous paracetamol in management of labour pains in a low resource setting: a randomized clinical trial. J Matern Fetal Neonatal Med. 2022 Dec;35(25):6320-6328. doi: 10.1080/14767058.2021.1911995. Epub 2021 Apr 26.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): May 10, 2020

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Acetaminophen; Meperidine
• Other Study ID Numbers: 11/2019OBSGN/27

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No