<?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>IRCT20121229011923N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-23</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effecacy of EMLA  anesthetic cream , 2% lidocaine gel and ice bag on the severity of pain caused by  venipuncture in  6-12 hospitalized  children Department of Pediatrics, Alhadi Shoushtar Hospital in 2018</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effecacy of EMLA  anesthetic cream , 2% lidocaine gel and ice bag on the severity of pain caused by  venipuncture in  6-12 hospitalized  children Department of Pediatrics, Alhadi Shoushtar Hospital in 2018</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35402</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 160 children were randomly selected using randomly selected random access criteria and blocks were randomly selected using four blocks, so that the block of 2 people will be placed in each intervention group. And will be divided into 4 groups of 40 people. The first group (using spelling anesthetic cream), the second group (using lidocaine gel 2%), the third group (using the ice bag) and the fourth group (control).</study_design>
      <phase>3</phase>
      <hc_freetext>Evaluation of pain in children during sedation.</hc_freetext>
      <i_freetext>"Intervention group 1": Use of EMLA cream, spray cream 1.5 grams at the patient's placement site, 60-45 minutes before placement, and covered with semi-permeable dressing. After 45 minutes, the dressing is removed. And the cream with cotton alcohol will be cleaned up to 70%, and the nurse will work.                                                                                   "Intervention group 2": Using an ice bag, 5 pieces of ice with dimensions of 4 × 2 × 2 cm are placed in latex gloves and placed for 3 minutes on the spot, then remove the ice bag and place With alcohol cotton, 70% is cleaned and done by the nurse.                                                              "Intervention group 3": Use 2% lidocaine gel for 5 minutes for 12 minutes in the lidocaine gel vein and apply a semi-permeable dressing. Then, with cotton alcohol, remove the 70% gel. The nurse will go through.                "control group" will be routine care..</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:
I do not know

When:
I do not know

To whom:
I do not know

Conditions:
I do not know

Where to obtain:
I do not know

How to obtain:
I do not know

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Akram Hemmatipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shoushtar University of Medical Sciences, Khatam Al Anya Hospital</address>
        <city>Shoushtar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>64519-84381</zip>
        <telephone>+98 61 3623 3891</telephone>
        <email>hematipour.a64@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akram Hemmatipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khatam Al Anbia Hospital</address>
        <city>Shoushtar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>61357-15794</zip>
        <telephone>+98 61 3623 3891</telephone>
        <email>hematipour.a64@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being alert to the child
Not having an urgent need to get pregnant
Lack of susceptibility to spelling cream (lidocaine and perlocaine)
The absence of any skin disease</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children who have already been pregnant
Have taken a sedative or pain medication
Have verbal, mental, vision, hearing and mental disorders.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group 1": Use of EMLA cream, spray cream 1.5 grams at the patient's placement site, 60-45 minutes before placement, and covered with semi-permeable dressing. After 45 minutes, the dressing is removed. And the cream with cotton alcohol will be cleaned up to 70%, and the nurse will work.                                                                                   "Intervention group 2": Using an ice bag, 5 pieces of ice with dimensions of 4 × 2 × 2 cm are placed in latex gloves and placed for 3 minutes on the spot, then remove the ice bag and place With alcohol cotton, 70% is cleaned and done by the nurse.                                                              "Intervention group 3": Use 2% lidocaine gel for 5 minutes for 12 minutes in the lidocaine gel vein and apply a semi-permeable dressing. Then, with cotton alcohol, remove the 70% gel. The nurse will go through.                "control group" will be routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Evaluation of pain in children during IV line with Angiocate. Timepoint: Sampling will take place within 3 months. Method of measurement: In order to determine the severity of pain, a numerical scale of pain (NAS) and a behavioral pain scale (FLACC) will be used.The range of Numerical Scale (NAS) is from 0 to 10, where zero indicates no pain and a score of 5 indicates moderate pain and 10 indicates the highest pain rate. After explaining about the scoring and 5 minutes after the abdomen, the child is asked to measure his pain according to the numerical scale of the pain.Another tool is the use of the Behavioral Scale of Pain (FLACC), which includes five criteria for child behavior such as facial expression, foot movements, activity level, crying and relief, which is well known by nurses who are fully aware of the pain instrument. The behavior of the child is scored during the injection of this questionnaire.So the zero score for the least pain and the two score for the most pain in each criterion is considered. The score of each section is inserted separately and then the 5 sections are combined together to calculate the total pain behavior. The zero score range is the lowest and the 10 most range of these scores.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-17</approval_date>
        <contact_name>Ethics Committee of Ahvaz Jundishapur University</contact_name>
        <contact_address>Golestan Avenue, Esfand Alley Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
