Paracetamol for Intrapartum Analgesia

October 15, 2015 updated by: Hamdy Bakry Mohye Soliman El Kinawy, Ain Shams Maternity Hospital

Efficacy of Intravenous Paracetamol as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial

The aim of this study is to assess whether paracetamol is as effective as pethidine for analgesia during the first stage of labor.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

104

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Primiparity
  • Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes)
  • Maternal age between 20-30 years
  • Singleton term pregnancy (37-42 weeks of gestation)
  • Vertex-presenting fetus

Exclusion Criteria:

  • Clinical evidence of cephalopelvic disproportion
  • Scarred uterus; previous cesarean section, hysterotomy or myomectomy
  • Medical disorders associated with pregnancy, especially gastritis, peptic ulcer, bronchial asthma or renal impairment
  • Fetal distress
  • Receiving any regional or parenteral analgesia before recruitment in the study
  • Known hypersensitivity to the drug family

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Pethidine
Slow intravenous administration of pethidine, 50 mg to be diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team.
Drug: Pethidine
EXPERIMENTAL: Paracetamol
Patients will receive paracetamol intravenously (1 g in 100 mL) over 15 minutes (single dose), as an analgesic during the first stage of labor, given by a member of the study team.
Drug: Paracetamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of intravenous paracetamol to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale.
Time Frame: 4 hours
Assessment is to be done and followed up by the investigator at ½, 1, 2, 3 and 4 hours from drug administration. Scores range from 0 [no pain] to 10 [worst possible pain].
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

March 1, 2016

Study Completion (ANTICIPATED)

March 1, 2016

Study Registration Dates

First Submitted

October 15, 2015

First Submitted That Met QC Criteria

October 15, 2015

First Posted (ESTIMATE)

October 16, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP-PCM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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