Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis

January 26, 2017 updated by: Rajavithi Hospital

Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis: A Randomized Double Blind Placebo-controlled Trial

This randomized controlled trial, compares perioperative and postoperative pain score by using visual analog scale in pregnant women undergoing amniocentesis. The experimental group will be given oral paracetamol premedication whereas the controlled group will be given oral placebo premedication.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Perioperative and postoperative amniocentesis are often painful which cause concerns to those who has to undergo amniocentesis. Anxiety is one of the factor that may prolong operative time, resulting in an increase risk of complication from the procedure. Furthermore, pregnant women, in order to relief the pain, might require others drugs, which has both maternal and fetal side effect. So In conclusion, this study aims to compare efficacy of oral paracetamol premedication and oral placebo premedication by using visual analog scale to evaluate pain.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singleton pregnant women undergo amniocentesis for the first time at Rajavithi Hospital in 2016-2017

Exclusion Criteria:

  • Pregnant women with psychiatric disorder
  • Contraindicated to paracetamol
  • Pregnant women undergoing amniocentesis due to fetal anomaly
  • Take oral paracetamol or other analgesics within 24-48 hrs before operation
  • Deny to participate the research

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comparator1: Paracetamol 650 mg (325 mg/tablet) oral
Drug: Paracetamol Comparison pain score between paracetamol and placebo
Drug: Paracetamol
Placebo Comparator: Comparator 2: Placebo oral
Drug: placebo Comparison pain score between paracetamol and placebo
Drug: Placebo Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Different in pain score on visual analog scale in amniocentesis between controlled group (placebo) and experimental group (paracetamol).
Time Frame: 1 yrs
1 yrs

Collaborators and Investigators

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

Sponsor

Rajavithi 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 (Actual)

November 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

January 26, 2017

First Posted (Estimate)

January 27, 2017

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJPARA

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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