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Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03035045
Recruitment Status : Unknown
Verified November 2016 by Rajavithi Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Information provided by (Responsible Party):
Rajavithi Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Amniocentesis Drug: Paracetamol Drug: Placebo Oral Tablet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis: A Randomized Double Blind Placebo-controlled Trial
Actual Study Start Date : November 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03035045

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Rajavithi Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Rajavithi Hospital
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Responsible Party: Rajavithi Hospital Identifier: NCT03035045    
Other Study ID Numbers: RJPARA
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: November 2016
Additional relevant MeSH terms:
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Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs