<?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>IRCT20230710058733N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-26</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of pain after abdominal surgery in patients receiving ketorolac and nasocalcin spray or lidocaine and nasocalcin spray</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of pain after abdominal surgery in patients receiving ketorolac and nasocalcin spray or lidocaine and nasocalcin spray</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>59</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71195</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, a list of all patients who were willing to participate in the study was first prepared, and after matching the patients who met the inclusion criteria, we assigned a number to each patient. We considered numbers 1 to 29 as group A and 30 to 59 as group B. So, using the online random number table, the patients were divided into two groups (A group receiving intravenous nasocalcin spray and Ketorolac ampoule and B group receiving intravenous nasocalcin spray and lidocaine ampoule), Blinding description: This research is a double-blind clinical trial (in order to make this study double-blind, the drugs used for the patients at the beginning of the study are A/B by the supervisor of the surgery department so that the clinical caregiver and the participants do not know the type of drug received.</study_design>
      <phase>2</phase>
      <hc_freetext>Pain after abdominal surgery.</hc_freetext>
      <i_freetext>Intervention 1: 2 puffs of nasocalcin and Ketorolac 30 mg ampoules were received intravenously. After patients enter the operating room, patients under general anesthesia with the same drugs (propofol 2 mg per kg of patient weight or Nesdonal 5 mg per kg of patient weight, midazolam 0.01 mg per kg of patient weight, fentanyl 2 - 3 macros per kilogram of patient weight and atrocurium 0.5 mg per kilogram of patient weight for induction and for maintenance, 1-2% isoflurane and oxygen N2o (50/50) were used. For patients during surgery, 1 macro per Every kilogram of the patient's weight, fentanyl was repeated every hour, and then at the end of the surgery, the reverse muscle relaxant was performed by a mixture of neostigmine and atropine. Then, after the surgery and at 6, 12, 24 hours after the operation, the pain level of the patients was measured according to the pattern VAS was checked and in case of VAS&gt;5, pethidine 30-50mg was injected intravenously to the patients and at the end of the first day, the amount of narcotic used was recorded in the questionnaire by a trained nurse. Intervention 2: They received 2 puffs of nasocalcin spray and lidocaine ampoules intravenously, and after the patients entered the operating room, the patients were under general anesthesia with the same drugs (propofol 2 mg per kg of patient weight or Nesdonal 5 mg per kg of patient weight) , midazolam 0.01 mg per kg of patient weight, fentanyl 2-3 macros per kg of patient weight and atrocurium 0.5 mg per kg of patient weight for induction and for maintenance of isoflurane 1-2% and oxygen N2o (50/50) ) was used. For patients during surgery, 1 macro per kilogram of the patient's weight of fentanyl was repeated every hour, and then at the end of the surgery, a reverse muscle relaxant was performed by a mixture of neostigmine and atropine. Then after the surgery and at 6 hours , 12,24, after the operation, the pain level of the patients was checked based on the VAS model, and in the case of VAS&gt;5, pethidine 30-50 mg was injected intravenously to the patients, and at the end of the first day, the amount of narcotic used was recorded in a questionnaire by a trained nurse. It was registered.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mahnaz Narimani Zamanabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>At the beginning of Damāvand Street, Imam Hossein Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1676855733</zip>
        <telephone>+98 21 7719 0836</telephone>
        <email>Mahdieh.ir72@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz Narimani Zamanabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>At the beginning of Damāvand Street, Imam Hossein Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1676855733</zip>
        <telephone>+98 21 7719 0836</telephone>
        <email>mahdieh.ir72@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being 15-75 years old
Sign a personal consent form to enter the study
American Society of Anesthesiologists 1-2
Non-use of drugs and alcohol
Elective surgery</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Decreased level of consciousness
Hemodynamic disorder
Abnormal intraoperative bleeding
Length of operation more than 4 hours</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T81.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified complication of procedure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>2 puffs of nasocalcin and Ketorolac 30 mg ampoules were received intravenously. After patients enter the operating room, patients under general anesthesia with the same drugs (propofol 2 mg per kg of patient weight or Nesdonal 5 mg per kg of patient weight, midazolam 0.01 mg per kg of patient weight, fentanyl 2 - 3 macros per kilogram of patient weight and atrocurium 0.5 mg per kilogram of patient weight for induction and for maintenance, 1-2% isoflurane and oxygen N2o (50/50) were used. For patients during surgery, 1 macro per Every kilogram of the patient's weight, fentanyl was repeated every hour, and then at the end of the surgery, the reverse muscle relaxant was performed by a mixture of neostigmine and atropine. Then, after the surgery and at 6, 12, 24 hours after the operation, the pain level of the patients was measured according to the pattern VAS was checked and in case of VAS&gt;5, pethidine 30-50mg was injected intravenously to the patients and at the end of the first day, the amount of narcotic used was recorded in the questionnaire by a trained nurse.</i_keyword>
      <i_keyword>They received 2 puffs of nasocalcin spray and lidocaine ampoules intravenously, and after the patients entered the operating room, the patients were under general anesthesia with the same drugs (propofol 2 mg per kg of patient weight or Nesdonal 5 mg per kg of patient weight) , midazolam 0.01 mg per kg of patient weight, fentanyl 2-3 macros per kg of patient weight and atrocurium 0.5 mg per kg of patient weight for induction and for maintenance of isoflurane 1-2% and oxygen N2o (50/50) ) was used. For patients during surgery, 1 macro per kilogram of the patient's weight of fentanyl was repeated every hour, and then at the end of the surgery, a reverse muscle relaxant was performed by a mixture of neostigmine and atropine. Then after the surgery and at 6 hours , 12,24, after the operation, the pain level of the patients was checked based on the VAS model, and in the case of VAS&gt;5, pethidine 30-50 mg was injected intravenously to the patients, and at the end of the first day, the amount of narcotic used was recorded in a questionnaire by a trained nurse. It was registered.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 1 hour and 6, 12, 24 hours after the operation, the amount. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The amount of narcotic (pethidine) received after the operation. Timepoint: After surgery. Method of measurement: Amount of drug used.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-15</approval_date>
        <contact_name>Ethics Committee of Tehran Islamic Azad University of Medical Sciences</contact_name>
        <contact_address>Head Office of Islamic Azad University of Medical Sciences, Tehran, Ayene Boulevard, Nabsheh Giley Street, Amir Pabarja Street, Do Rahi Kolak, Dr. Shariati Street, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
