<?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>IRCT20260611069751N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-23</date_registration>
      <primary_sponsor>Lady Reading Hospital Medical Teaching Institution (LRH-MTI)</primary_sponsor>
      <public_title>Effect of Ketamine gargles on sore throat after surgery</public_title>
      <acronym>KGPOST</acronym>
      <scientific_title>Comparison of frequency of post operative sore throat in patients undergoing oral endotracheal  intubation with ketamine  gargles and normal saline</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-10-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>156</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90916</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Single-blind, parallel-group interventional study. Participants were blinded to treatment allocation. Patients received either ketamine gargles or normal saline gargles on alternate study days. Investigators and care providers were aware of group allocation. Postoperative sore throat was assessed after oral endotracheal intubation, Blinding description: Participants were blinded to the allocated intervention. Patients were not informed whether they received ketamine gargles or normal saline gargles. The investigators and care providers were aware of the allocated intervention. Therefore, the study was conducted as a single-blind trial with participant blinding only.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Postoperative sore throat following oral endotracheal intubation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants received ketamine gargles containing 50mg ketamine diluted in 29ml water and gargled for 40 seconds before induction of general anesthesia. Intervention 2: Control group: Participants received normal saline gargles of equal volume and gargled for 40 seconds before induction of general anesthesia.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Individual participant data will not be shared publicly to protect participant confidentiality and privacy .the study was conducted for academic purposes and no plan exists for public release of deidentified dataset.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saima Askar Bangash</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Cell, Department of Anesthesiology, Lady Reading Hospital Medical Teaching Institution(LRH-MTI),Peshawar,Pakistan</address>
        <city>Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25000</zip>
        <telephone>+92 91 9211430</telephone>
        <email>docseeme@gmail.com</email>
        <affiliation>Lady reading Hospital Medical Teaching Institution (LRH-MTI)</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saima Askar Bangash</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Cell, Lady Reading Hospital Medical Teaching Institution (LRH_MTI), Peshawar, Pakistan</address>
        <city>Peshawar</city>
        <country1>Pakistan</country1>
        <zip>25000</zip>
        <telephone>+92 91 9211430</telephone>
        <email>docseeme@gmail.com</email>
        <affiliation>Lady Reading Hospital Medical Teaching Institution(LRH-MTI)</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient gender male-female
Patient age (18-70) Years
Patients  undergoing oral endotracheal intubation as per operational definition
ASA physical status I or II
Provided written informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Known case of allergies to ketamine
Upper respiratory tract infection
Pre existing throat pathology
Refusal to participate
More than one intubation attempt
Those having ng tube already placed</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R07.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain in throat</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: Participants received ketamine gargles containing 50mg ketamine diluted in 29ml water and gargled for 40 seconds before induction of general anesthesia.</i_keyword>
      <i_keyword>Control group: Participants received normal saline gargles of equal volume and gargled for 40 seconds before induction of general anesthesia.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frequency of postoperative sore throat following oral endotracheal intubation. Timepoint: 0,2,4,8 and 24 hours after extubation. Method of measurement: Postoperative sore throat was assessed by direct patient interview and graded using a standardized postoperative sore throat grading scale 0,2,4,8 and 24hours after extubation.</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>Lady Reading Hospital Medical Teaching Institution (LRH-MTI)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-31</approval_date>
        <contact_name>Institutional Review Board (IRB),Lady Reading Hospital Medical Teaching Institution(LRH-MTI)</contact_name>
        <contact_address>Research Cell,4th floor, MedSurge Block, Lady Reading Hospital,Peshawar,Kpk,Pakistan Peshawar Khyber pakhtoonkhwa Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
