Preemptive and Preventive Use of Paracetamol for Pain Relief After Cesarean Section

March 16, 2016 updated by: Ozlem Ozmete, Baskent University

A Double Blind Randomised Controlled Trial of Preemptive and Preventive Use of Paracetamol for Pain Relief After Cesarean Section

The investigators designed a prospective randomized study to investigate the efficacy of intravenous (IV) preemptive versus preventive paracetamol on postoperative pain scores, patient satisfaction, total morphine consumption and the incidence of morphine-related side effects in patients undergoing cesarean section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 4

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

38 weeks pregnancy, elective cesarean section.

-

Exclusion Criteria:

morbid obesity, cardiac failure, depression.

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Preemptive (Group PE),
Group I: i.V. paracetamol 1 g (100 ml) was given 30 min before induction of anesthesia.
Drug: Paracetamol was given intravenously in both group at different times
Active Comparator: Group Preventive (Group PV),
Group II: i.V. paracetamol 1 g (100 ml) was given before the end of surgery.
Drug: Paracetamol was given intravenously in both group at different times

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual analog score (VAS) for pain
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Baskent University

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

May 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (Estimate)

March 21, 2016

Study Record Updates

Last Update Posted (Estimate)

March 21, 2016

Last Update Submitted That Met QC Criteria

March 16, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA15/80

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Cesarean Section; Dehiscence

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