<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03035045</url>
  </required_header>
  <id_info>
    <org_study_id>RJPARA</org_study_id>
    <nct_id>NCT03035045</nct_id>
  </id_info>
  <brief_title>Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis</brief_title>
  <official_title>Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis: A Randomized Double Blind Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rajavithi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rajavithi Hospital</source>
  <brief_summary>
    <textblock>
      This randomized controlled trial, compares perioperative and postoperative pain score by&#xD;
      using visual analog scale in pregnant women undergoing amniocentesis. The experimental group&#xD;
      will be given oral paracetamol premedication whereas the controlled group will be given oral&#xD;
      placebo premedication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Perioperative and postoperative amniocentesis are often painful which cause concerns to those&#xD;
      who has to undergo amniocentesis. Anxiety is one of the factor that may prolong operative&#xD;
      time, resulting in an increase risk of complication from the procedure. Furthermore, pregnant&#xD;
      women, in order to relief the pain, might require others drugs, which has both maternal and&#xD;
      fetal side effect. So In conclusion, this study aims to compare efficacy of oral paracetamol&#xD;
      premedication and oral placebo premedication by using visual analog scale to evaluate pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Different in pain score on visual analog scale in amniocentesis between controlled group (placebo) and experimental group (paracetamol).</measure>
    <time_frame>1 yrs</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Amniocentesis</condition>
  <arm_group>
    <arm_group_label>Comparator1: Paracetamol 650 mg (325 mg/tablet) oral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Paracetamol Comparison pain score between paracetamol and placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator 2: Placebo oral</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Drug: placebo Comparison pain score between paracetamol and placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol</intervention_name>
    <arm_group_label>Comparator1: Paracetamol 650 mg (325 mg/tablet) oral</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <arm_group_label>Comparator 2: Placebo oral</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton pregnant women undergo amniocentesis for the first time at Rajavithi&#xD;
             Hospital in 2016-2017&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women with psychiatric disorder&#xD;
&#xD;
          -  Contraindicated to paracetamol&#xD;
&#xD;
          -  Pregnant women undergoing amniocentesis due to fetal anomaly&#xD;
&#xD;
          -  Take oral paracetamol or other analgesics within 24-48 hrs before operation&#xD;
&#xD;
          -  Deny to participate the research&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rajavithi Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03035045
org study id: RJPARA
nct id: NCT03035045
lead sponsor: 
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Different in pain score on visual analog scale in amniocentesis between controlled group (placebo) and experimental group (paracetamol).
time frame: 1 yrs
arm group label: Comparator1: Paracetamol 650 mg (325 mg/tablet) oral
arm group type: Experimental
description: Drug: Paracetamol Comparison pain score between paracetamol and placebo
arm group label: Comparator 2: Placebo oral
arm group type: Placebo Comparator
description: Drug: placebo Comparison pain score between paracetamol and placebo
intervention type: Drug
intervention name: Paracetamol
arm group label: Comparator1: Paracetamol 650 mg (325 mg/tablet) oral
intervention type: Drug
intervention name: Placebo Oral Tablet
arm group label: Comparator 2: Placebo oral
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Acetaminophen