<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20180708040381N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-17</date_registration>
      <primary_sponsor>Azad Islamic University, Najaf Abad Branch</primary_sponsor>
      <public_title>The effect of acetaminophen drip on pain after cesarean section</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of intravenous acetaminophen effect with 24-hour and routine drip on control of pain in patients undergoing cesarean section</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60749</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The women who met the inclusion criteria were randomly divided into two groups 1 and 2. In this way, the patients referred in group 1 on even days and the patients referred in group 2 on odd days, Blinding description: The patients referred to each group as well as the person who recorded the patients' details did not know how to classify.
The person taking the drip acetaminophen or acetaminophen routinely did not know which person was in group A or B. The researcher and the evaluator knew what the patient group was.</study_design>
      <phase>3</phase>
      <hc_freetext>post operative pain.</hc_freetext>
      <i_freetext>Intervention 1: After the patient was fully conscious and in recovery in the 24-hour drip group, 2 mg / kg morphine and 4000 mg of acetaminophen were poured into the PCA pump and injected into the patient within 24 hours. Patients' VAS was evaluated in recovery at 6 hours, 12 hours, 18 hours and 24 hours after surgery, respectively. The acetaminophen used in this study was the so-called Apotel brand (manufactured in Greece and distributed by Koble Drug), which was used in 1000 mg ready-to-inject vials. The onset time of analgesic effect is 5 to 10 minutes and the maximum effect time is one hour and the duration of its effect is 4-6 hours. The PCA pump used was called Starmed, made in China, with a maintenance dose setting of 4 to 6 cc per hour with a 15-minute bolus interval for 24-hour acetaminophen drip. Intervention 2: In the routine intravenous acetaminophen group, only 2 mg / kg morphine was poured into the PCA pump and 1000 mg intravenous acetaminophen was injected into the patient every 6 hours.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All content and study data will be shared after publication.

When:
Access will start from the time the article is published.

To whom:
All authors and managing director of the publication

Conditions:
To use the contents of this study in dissertations or articles,Students and researchers have access to the documents of this study.

Where to obtain:
Dr Mehdi Izadi Zaman Abadi
Address: No6. Pirooz Building. North Mejmar Ave. Manoucheri Ave.Ferdoosi Ave
Post Code: 8143834438
E-mail: mimi_izadi2@yahoo.com
Tel: 00989131043958

How to obtain:
Email or request will be read,and after consulting with other authors, the request will be reviewed and answered.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Mehdi Izadi Zaman Abadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No6.Pirooz Building, North Mejmar Ave. Manouchehri Ave. Ferdoosi Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8143834438</zip>
        <telephone>0098312724538</telephone>
        <email>mimi_izadi2@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mehdi Izadi Zaman Abadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No6. Pirooz Building. North Mejmar Ave. Manoucheri Ave.Ferdoosi Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8143834438</zip>
        <telephone>0098312724538</telephone>
        <email>mimi_izadi2@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged 16 to 40 years
Candidate for cesarean section
No smoke and opioids consumption
ASA class 1 or 2</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Allergy to any of the drugs used in study
Liver disease
History of seizure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After the patient was fully conscious and in recovery in the 24-hour drip group, 2 mg / kg morphine and 4000 mg of acetaminophen were poured into the PCA pump and injected into the patient within 24 hours. Patients' VAS was evaluated in recovery at 6 hours, 12 hours, 18 hours and 24 hours after surgery, respectively. The acetaminophen used in this study was the so-called Apotel brand (manufactured in Greece and distributed by Koble Drug), which was used in 1000 mg ready-to-inject vials. The onset time of analgesic effect is 5 to 10 minutes and the maximum effect time is one hour and the duration of its effect is 4-6 hours. The PCA pump used was called Starmed, made in China, with a maintenance dose setting of 4 to 6 cc per hour with a 15-minute bolus interval for 24-hour acetaminophen drip.</i_keyword>
      <i_keyword>In the routine intravenous acetaminophen group, only 2 mg / kg morphine was poured into the PCA pump and 1000 mg intravenous acetaminophen was injected into the patient every 6 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Score. Timepoint: First 24 hr After Surgery Every 6 hr. Method of measurement: VAS Score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Azad Islamic University, Najaf Abad Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-27</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University , Najaf Abad Branch</contact_name>
        <contact_address>Islamic Azad University, Najaf Abad Branch, University Boulevard, Najaf Abad, Isfahan Najaf Abad Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
