Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis

Rajavithi Hospital

Status: Unknown

Conditions: Amniocentesis

Treatments: Drug: Paracetamol; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03035045

RJPARA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups, including a placebo group

Comparator1: Paracetamol 650 mg (325 mg/tablet) oral

Experimental group

Description:

Drug: Paracetamol Comparison pain score between paracetamol and placebo

Treatment:

Drug: Paracetamol

Comparator 2: Placebo oral

Placebo Comparator group

Description:

Drug: placebo Comparison pain score between paracetamol and placebo

Treatment:

Drug: Placebo Oral Tablet