Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis

Amniocentesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03035045
• Other study ID #: RJPARA
• Status: Active, not recruiting
• Phase: N/A
• First received: November 16, 2016
• Last updated: January 26, 2017
• Start date: November 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2016
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Amniocentesis

Intervention

Drug:
• Paracetamol

• Placebo Oral Tablet

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Different in pain score on visual analog scale in amniocentesis between controlled group (placebo) and experimental group (paracetamol).		1 yrs