Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Amniocentesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

Drug: Paracetamol Comparison pain score between paracetamol and placebo

Group Type EXPERIMENTAL

Paracetamol

Intervention Type DRUG

Comparator 2: Placebo oral

Drug: placebo Comparison pain score between paracetamol and placebo

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Interventions

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Paracetamol

Intervention Type DRUG

Placebo Oral Tablet

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes