<?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>IRCT20230816059169N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-11</date_registration>
      <primary_sponsor>CMH Rawalpindi</primary_sponsor>
      <public_title>LIGNOCAINE AS ANALGESIA IN BURN PATIENTS</public_title>
      <acronym></acronym>
      <scientific_title>EFFICACY OF INTRAVENOUS LIGNOCAINE AS ADJUVANT ANALGESIA IN BURN PATIENTS DURING CHANGE OF DRESSING UNDER GENERAL ANESTHESIA</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72139</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients were divided into two groups after randomization in Group L (n=45) as the intravenous lignocaine group and Group A (n=45) as the non-adjuvant group without intravenous lignocaine. The method of randomization was non-probability consecutive sampling via lottery method. All the patients were thoroughly counselled regarding the procedure and in case the patients were unable to communicate, permission was taken from the next of kin. An informed written high-risk consent was taken for surgery, Blinding description: The participants in the study were briefed about the study protocol or how the results would be analyzed. 100 ml burettes containing the pre-mixed drug dose of lignocaine and one containing only normal saline were used to prevent observer bias.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Burns.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group L (Intravenous lignocaine) Patients in Group L received intravenous lignocaine at a dose of 1.5 mg/kg infused over 5 minutes before induction whereas patient in Group A only received intravenous paracetamol and nalbuphine. Anesthesia was induced with intravenous propofol at 1.5 mg/kg, paralysis was achieved with atracurium 0.5 mg/kg and anesthesia was maintained with inhalational isoflurane at 1 MAC (minimum alveolar concentration). Intervention 2: Control group: Group A (Normal saline group) is the non-adjuvant group without intravenous lignocaine.</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:
Data collected included the Primary variables ie heart rate, systolic and diastolic blood pressure, and oxygen saturation 5 minutes post-intubation and 15 minutes into the procedure and median pain scores 1-hour post-extubation in the recovery on standardized Visual Analog Scale

When:
After approval from the primary author

To whom:
Public

Conditions:
Study purpose

Where to obtain:
the data would be available via email after contacting primary author ,email address is xaheertiwana@gmail.com

How to obtain:
An email would be sent to the primary author for data sharing request and once approved a link would be given to download the data.All this process would require around 7 days

Comments:
This study needs furher research on a large scale</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Muhammad  Zaheer ud din</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>CMH RWP</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 333 4319191</telephone>
        <email>xaheertiwana@gmail.com</email>
        <affiliation>CMH Rawalpindi</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Muhammad  Zaheer ud din</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>CMH RWP</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 333 4319191</telephone>
        <email>xaheertiwana@gmail.com</email>
        <affiliation>CMH Rawalpindi</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All ASA status patients presenting to the operating room for change of dressing under general anesthesia for full thickness burns</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient with metastatic disease, post chemotherapy
Major cardiac or respiratory disease
Patients with partial thickness burns
Those unwilling to be included in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T30.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Burn of unspecified body region, unspecified degree</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group L (Intravenous lignocaine) Patients in Group L received intravenous lignocaine at a dose of 1.5 mg/kg infused over 5 minutes before induction whereas patient in Group A only received intravenous paracetamol and nalbuphine. Anesthesia was induced with intravenous propofol at 1.5 mg/kg, paralysis was achieved with atracurium 0.5 mg/kg and anesthesia was maintained with inhalational isoflurane at 1 MAC (minimum alveolar concentration)</i_keyword>
      <i_keyword>Control group: Group A (Normal saline group) is the non-adjuvant group without intravenous lignocaine</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean heart rate, blood pressure and oxygen saturation. Timepoint: Pre-induction, 5 min and 30 minutes into procedure. Method of measurement: Standard cardiac monitor.</prim_outcome>
      <prim_outcome>Median pain scores on standardized Visual Analog Scale. Timepoint: 1-hour post-extubation in the recovery. Method of measurement: Standard Visual Analog Scale.</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>CMH Rawalpindi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-20</approval_date>
        <contact_name>ERB Combined Military Hospital Rawalpindi (CMH RWP)</contact_name>
        <contact_address>CMH RWP Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
