Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis

Not Applicable

• Conditions: Amniocentesis
• Interventions: Drug: Placebo Oral Tablet; Drug: Paracetamol

• Registration Number: NCT03035045
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2017-01-26
• Last Update Submitted: 2017-01-26
• Study First Posted: 2017-01-27
• Last Update Posted: 2017-01-27
• Primary Completion: 2017-06
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Different in pain score on visual analog scale in amniocentesis between controlled group (placebo) and experimental group (paracetamol).	1 yrs

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand