<?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>IRCT201311168768N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-12-20</date_registration>
      <primary_sponsor>Vice chancellor for Research and Technology, Hamadan University Of Medical Sciences</primary_sponsor>
      <public_title>Comparison of diclofenac and acetaminophen in the managment of pain after back surgery.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of diclofenac  and  acetaminophen combined with patient controlled analgesia, in the managment of pain after laminectomy surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9258</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>acute postoperative pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Diclofenac suupp 100mg immediately before induction of anesthesia and 12 hours after surgery, infusion of 100 cc normal saline 15 minutes before the end of the surgery and 12 hours after surgery.&#13;
In recovery an intravenous patient controlled analgesia (IV PCA) pump containing 100 cc normal saline and 20 cc fentanyl (1000µg) will be connected. The pump characteristics: 2 cc continous  flow and bolus of 0.5 cc with lockout interval of 15 minutes.   &#13;
In the case of sedation score above 3,  IV PCA will be hold and patient will be monitored. In the case of pain score above 4, morphin four miligrams IV will be injected and  recorded in  the questionare. Intervention 2: Control group: will recieve placebo suppository immediately before induction of anesthesia and 12 hours after surgery, infusion of 1 gram intravenous acetaminophen in  100 cc normal saline  15 minutes before the end of the surgery and 12 hours after surgery.&#13;
In recovery an intravenous patient controlled analgesia( IV PCA) pump containing 100 cc normal saline and 20 cc fentanyl (1000µg) will be connected. The pump characteristics: 2 cc continous  flow and bolus of 0.5 cc with lockout interval of 15 minutes.  &#13;
In the case of sedation score above 3 IV PCA will be hold and patient will be monitored. In the case of pain score above 4, morphin 4 miligrams IV  will be injected and  recorded in  the questionare.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahshid Nkooseresht M.D</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiolgy Department, Besat hospital, ,Shahid Motahari Blvd, Resalat Square, Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6514845471</zip>
        <telephone>+98 81 1264 0049</telephone>
        <email>nikooseresht@umsha.ac.ir</email>
        <affiliation>Hamadan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahshid Nikooseresht  M.D</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiolgy Department, Besat Hospital, Shahid Motahari Blvd, Resalat Square, Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6514845471</zip>
        <telephone>+98 81 1264 0049</telephone>
        <email>nikooseresht@umsha.ac.ir</email>
        <affiliation>Hamadan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria:  Patients candidate for laminectomy with American Society of Anesthesiologists ( ASA  ) class  I, II &#13;
Exclusion criteria: Patients with Coagulation disorders, seizure, Asthma, renal or hepatic disease, addiction to opioids or alchohol, sensitivity to NSAIDS or acetaminophen, peptic ulcer disease, opium or NSAIDs use in recent 24 hr, surgery time more than 150 minutes and patient refusal</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.0A</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pain</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>Intervention group: Diclofenac suupp 100mg immediately before induction of anesthesia and 12 hours after surgery, infusion of 100 cc normal saline 15 minutes before the end of the surgery and 12 hours after surgery.&#13;
In recovery an intravenous patient controlled analgesia (IV PCA) pump containing 100 cc normal saline and 20 cc fentanyl (1000µg) will be connected. The pump characteristics: 2 cc continous  flow and bolus of 0.5 cc with lockout interval of 15 minutes.   &#13;
In the case of sedation score above 3,  IV PCA will be hold and patient will be monitored. In the case of pain score above 4, morphin four miligrams IV will be injected and  recorded in  the questionare.</i_keyword>
      <i_keyword>Control group: will recieve placebo suppository immediately before induction of anesthesia and 12 hours after surgery, infusion of 1 gram intravenous acetaminophen in  100 cc normal saline  15 minutes before the end of the surgery and 12 hours after surgery.&#13;
In recovery an intravenous patient controlled analgesia( IV PCA) pump containing 100 cc normal saline and 20 cc fentanyl (1000µg) will be connected. The pump characteristics: 2 cc continous  flow and bolus of 0.5 cc with lockout interval of 15 minutes.  &#13;
In the case of sedation score above 3 IV PCA will be hold and patient will be monitored. In the case of pain score above 4, morphin 4 miligrams IV  will be injected and  recorded in  the questionare.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score. Timepoint: In recovery, 6 hours after surgery, 12 hours after surgery, 24 hours after surgery. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Total dose of narcotic used in patient controlled analgesia. Timepoint: 24 hours after surgery. Method of measurement: Observation of PCA  pomp and calculating the used narcotic by microgram.</prim_outcome>
      <prim_outcome>Patient satisfaction. Timepoint: 24 hours after surgery. Method of measurement: Questionare.</prim_outcome>
      <prim_outcome>Total dose of Adjuvant analgesic. Timepoint: 24 hours after surgery. Method of measurement: With questionare and by miligram.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nausea and vomiting. Timepoint: In recovery, 6 hours after surgery, 12 hours after surgery, 24 hours after surgery. Method of measurement: Questionare.</sec_outcome>
      <sec_outcome>Sedation score. Timepoint: At the end of the surgery, after 24 hours. Method of measurement: By using Ramsy sedation scale.</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>Vice chancellor for Research and Technology, Hamadan University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-10-21</approval_date>
        <contact_name>Committee of Ethics in Research,  Hamadan University of Medical Sciences</contact_name>
        <contact_address>Hamadan University of Medical Science, Shahid Fahmideh Street, Hamadan Hamadan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
