<?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>IRCT20100127003213N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-28</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Glossopharyngeal nerve block compared to Ropivacaine infiltration in improving tonsillectomy pain in children.</public_title>
      <acronym></acronym>
      <scientific_title>Glossopharyngeal nerve block compared to Ropivacaine infiltration as part of a multimodal analgesic regimen for post tonsillectomy pain relief in children A randomized controlled clinical study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74951</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly allocated into three groups by block randomization. In this technique, a permutation block of size 6 will be made for patients of two groups G,R &amp; C. In each block, equal numbers for three groups will be considered in alternative positions. Then 15 blocks of size 6 will be selected randomly and patients will be allocated randomly and equally into three groups according to these permutation block. block sequence will be prepare by www.sealedenvelope.com, Blinding description: In group G, the surgeon will inject 5 ml of 0.2% ropivacaine solution in the glossopharyngeal block.
In group R, the surgeon will inject 5 ml of 0.2% ropivacaine solution in the tonsil cavity and its surrounding areas.
In group C, at the end of the operation, in order to blind the study in half of the group (15 people), similar to the intervention group (G), the glossopharyngeal nerve block was performed by the surgeon using a placebo (0.9% normal saline) and in 15 people Another group, similar to group (R), is infiltration in the tonsil cavity with a placebo (0.9% normal saline solution).
In the operating room, all study drugs will be provided by the only person familiar with the study (Nurse anesthetist). The anesthesiologist, patients, and other personnel involved in the work are blinded to the drugs injected in this study. This study is double-blind.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Tonsillectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (G) : In all three groups, after the induction of anesthesia, the patients receive intravenous drugs of the studied analgesic regimen, which includes 500 μg/kg of ketamine and 150 μg/kg of dexamethasone.  All surgeries will be performed by an otolaryngologist and cold dissection with ligature method. At the end of the surgery, in group (G), the surgeon injects 5 ml of 0.2% ropivacaine solution on each side of the glossopharyngeal nerve block. (Using a size 25 spinal needle at a 45 degree angle, it is inserted into the middle part of the palatopharyngeal fold in the back mucosa tissue of the pharynx, and then with a depth of 0.5 cm in the back wall of the pharynx, after negative aspiration, the injection is performed). Intervention 2: Intervention group (R) :  At the end of surgery, in group (R), The surgeon w injects 5 ml of 0.2% Ropivacaine solution in the tonsil cavity and its surrounding areas after negative aspiration. Intervention 3: Control group (C) : After the induction of anesthesia, in addition to receiving intravenous drugs for the studied analgesic regimen, which is common in all groups, the basic analgesic regimen includes Paracetamol at the rate of 15 mg/kg and ketorolac at the rate of 470 μg/kg. receive intravenously and in order to blind the study, In group C, at the end of the operation, 15 people, similar to the intervention group (G), and another 15 people, similar to the intervention group (R), were injected using a placebo (0.9% normal saline).</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 It is against our policy.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Nemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology Department, Faghihi Hospital, Zand Street.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134844119</zip>
        <telephone>+98 71 3647 4270</telephone>
        <email>maryambestwishes@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arash Farbood</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology Department, Faghihi Hospital, Zand Street.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1564471948</zip>
        <telephone>+98 71 3647 4270</telephone>
        <email>arashfarbood@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with ASA grade I or II (American Society of Anesthesiology classification)
Patients between 4 and 10 years old
Candidate for tonsillectomy or adenotonsillectomy with diagnosis of tonsillitis
The distance between the hospital and the patient's place of residence should be a maximum of 30 minutes by car</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>10 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Allergy to the drugs used in the study
Positive history of liver, kidney, Coagulation disorders and Diseases of the digestive system
Positive history of uncontrolled diseases of the cardiovascular system
Obstructive sleep apnoea
Taking painkillers other than study drugs in 24 hours before surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J03.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute tonsillitis, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (G) : In all three groups, after the induction of anesthesia, the patients receive intravenous drugs of the studied analgesic regimen, which includes 500 μg/kg of ketamine and 150 μg/kg of dexamethasone.  All surgeries will be performed by an otolaryngologist and cold dissection with ligature method. At the end of the surgery, in group (G), the surgeon injects 5 ml of 0.2% ropivacaine solution on each side of the glossopharyngeal nerve block. (Using a size 25 spinal needle at a 45 degree angle, it is inserted into the middle part of the palatopharyngeal fold in the back mucosa tissue of the pharynx, and then with a depth of 0.5 cm in the back wall of the pharynx, after negative aspiration, the injection is performed).</i_keyword>
      <i_keyword>Intervention group (R) :  At the end of surgery, in group (R), The surgeon w injects 5 ml of 0.2% Ropivacaine solution in the tonsil cavity and its surrounding areas after negative aspiration.</i_keyword>
      <i_keyword>Control group (C) : After the induction of anesthesia, in addition to receiving intravenous drugs for the studied analgesic regimen, which is common in all groups, the basic analgesic regimen includes Paracetamol at the rate of 15 mg/kg and ketorolac at the rate of 470 μg/kg. receive intravenously and in order to blind the study, In group C, at the end of the operation, 15 people, similar to the intervention group (G), and another 15 people, similar to the intervention group (R), were injected using a placebo (0.9% normal saline).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Every 15 minutes in the recovery room and at 24, 12, 6, 4, 2 hours after surgery. Method of measurement: CHEOPS scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The quality of the patient's sleep. Timepoint: First time. Method of measurement: In respect to standardized questionnaire.</sec_outcome>
      <sec_outcome>Painless swallowing. Timepoint: First time. Method of measurement: Patient history taking.</sec_outcome>
      <sec_outcome>The level of satisfaction of the patient's parents. Timepoint: After recovery. Method of measurement: In respect to standardized questionnaire.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-27</approval_date>
        <contact_name>Ethics Committee of Shiraz Medical School</contact_name>
        <contact_address>3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
