xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06031961</url>
    </required_header>
    <id_info>
      <org_study_id>Melatonin in PA</org_study_id>
      <nct_id>NCT06031961</nct_id>
    </id_info>
    <brief_title>The Premedication Properties of Oral Melatonin in Pediatrics Undergoing Therapeutic Cardiac Catheterization</brief_title>
    <official_title>A Double-blind Randomized Placebo - Controlled Trial of Oral Melatonin as Premedication Agent in Pediatrics Undergoing Therapeutic Cardiac Catheterization</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Al-Azhar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Al-Azhar University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The evaluation of oral melatonin efficacy as premedicant agent in pediatrics undergoing&#xD;
        elective cardiac interventions is the primary outcomes of our trail.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        About 65 % of children whom undergoing surgery and anesthesia are suffering from keen anxiety&#xD;
        and stress especially in the preoperative holding area. This situation mostly extends to the&#xD;
        parents and this can worse the child response before surgery. The intensity of child anxiety&#xD;
        had been reported to be a powerful predictor for incidence of hallucination in the recovery&#xD;
        period and new-onset unpleasant behavioral changes such as nightmares and enuresis. In&#xD;
        general, patients' preoperative anxiety if not controlled or reduced by premeditations, it&#xD;
        can influence the surgical outcomes such as the postoperative pain, analgesic requirements,&#xD;
        length of hospitality. Many of systemic physiological changes may be associated with the&#xD;
        anxiety; such as elevated respiratory rate, elevated blood pressure, increased the heart rate&#xD;
        and developing the risky of arrhythmia; all of these can be dilemmas and obstacles in the way&#xD;
        of the anesthesiologist in choosing the appropriate method of anesthesia or the appropriate&#xD;
        drugs for the starting and continuation of anesthesia. At the beginning of the eighties of&#xD;
        the last century, the midazolam had been presented as the finest oral premedication agent&#xD;
        which used in the pre-operative period for children to reduce the anxiety, and its quickly&#xD;
        achieved wide acceptance as the preferred primer before induction of anesthesia. Rapid&#xD;
        absorption during oral administration, multiple route administration and low incidence of&#xD;
        nausea with its use when compared with other benzodiazepines, all these features helped to&#xD;
        favor the midazolam for pre-operative use as a premedication in pediatrics. Despite the&#xD;
        decent advantages that midazolam has in use before surgical interventions as a premedication&#xD;
        agent, especially for children, it has some drawbacks that may affect the results of the&#xD;
        surgical procedure and the anesthesia plan. Paradoxical reactions, interaction with opioids,&#xD;
        overdue evacuation during the recovery time and capricious bioavailability are the most&#xD;
        common drawbacks of midazolam in general. Some of these effects of midazolam had been shown&#xD;
        to vary with patient age. In the presence of such drawbacks with the use of midazolam, the&#xD;
        emergence of a suitable alternative may be widely accepted. Naturally, the&#xD;
        N-acetyl-5-methoxy-tryptamine, which is also known as the Melatonin, is a biogenic amine&#xD;
        which is firstly discovered in the middle of last century (1958) by Aaron B. Lerner in Yale&#xD;
        University. After a while, the melatonin had been reported to be synthesized in animals,&#xD;
        plants and even in unicellular organisms such as bacteria. In humans, the melatonin is mainly&#xD;
        produced by the bovine pineal glands which is a small pine-cone shaped structure and located&#xD;
        on the roof of the 3rd ventricle, deeply within the brain. In addition to production of&#xD;
        melatonin; the main function of pineal gland; the gland also secrets some substances such as&#xD;
        Oxytocin, Serotonin and Orexin in responding to influencing by neurotransmitters from neurons&#xD;
        and nerve cells. The lymphocytes, bone marrow, eyes, and the gastrointestinal tract had been&#xD;
        recently documented to a site production of melatonin hormone in human body.&#xD;
  &#xD;
        Sleep cycle, mood, memory dreaming, immune activity, learning fertility and reproduction are&#xD;
        the common physiological activities which regulated mainly by the melatonin in humans, all of&#xD;
        these functions are accomplished through direct stimulation or binding to melatonin&#xD;
        receptors.&#xD;
  &#xD;
        European Medicines Agency had licensed the synthetic melatonin in form of tablets (2 mg) and&#xD;
        (3 mg) in United Kingdom (UK) and Hungary. Also there is a licensed oral solution of 1mg/ml.&#xD;
        The unlicensed synthetic melatonin is available in different forms from Kidmel® &amp; Kidnaps®,&#xD;
        Special Products Limited in the UK in liquid formulations and capsule formulation of 2 &amp; 3&#xD;
        mg.&#xD;
  &#xD;
        Many qualities of the chemical melatonin, which is mostly produced by the pineal gland, may&#xD;
        help explain why it has cardio protective benefits. Melatonin may have receptor-mediated or&#xD;
        receptor-independent protective effects. Ischemia/reperfusion (IR) injury has been shown to&#xD;
        affect many organs, including the heart, liver, kidney, gut, testis, brain, and lung.&#xD;
        Melatonin has been shown to offer numerous protective advantages. Melatonin's potent&#xD;
        antioxidant qualities, as well as its capacity to encourage the synthesis of other&#xD;
        antioxidants such as glutathione reductase, catalase, glutathione peroxidase, and superoxide&#xD;
        dismutase, all contribute to its protective effects.&#xD;
  &#xD;
        As a result, it acts as both an indirect antioxidant and a free radical scavenger. Because&#xD;
        melatonin receptors are found in the vasculature, it is possible that melatonin has local&#xD;
        control over cardiovascular diseases. Furthermore, the amount of melatonin generated by&#xD;
        persons suffering from coronary artery disease is inversely connected to the stage of the&#xD;
        disease-the less melatonin produced, the more advanced the disease.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">August 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 15, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>preoperative anxiety</measure>
      <time_frame>30 minutes before 2nd dose of premedication, 1 hour after 2nd dose premedication, At separation from parents, 5 minutes before induction of general anesthesia.</time_frame>
      <description>Modified Yale Preoperative Anxiety Scale (mYPAS)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sedation level</measure>
      <time_frame>1 hour after 2nd dose premedication, At separation from parents, 5 minutes before induction of general anesthesia.</time_frame>
      <description>The University of Michigan Sedation Scale (UMSS)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Anesthesia</condition>
    <arm_group>
      <arm_group_label>1st group: Melatonin group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>All children in this group have to receive 0.5 mg/kg of melatonin(maximum dose 20 mg) which will be administered orally on the night before surgery ( at 12 am) and immediately before 30 minutes before entering the catheterization room.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>2nd group: Placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>All children in this group have to receive a placebo which will be administered orally on the night before surgery and immediately before 30 minutes before entering the catheterization room.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>melatonin</intervention_name>
      <description>We will premedicate the children whom involved in the 1st group with 0.5 mg/kg oral melatonin in the midnight before surgery and the dose will be repeated at morning before getting in the catheterization room</description>
      <arm_group_label>1st group: Melatonin group</arm_group_label>
      <arm_group_label>2nd group: Placebo group</arm_group_label>
      <other_name>Placebo</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 4-12 years.&#xD;
  &#xD;
            -  scheduled for elective therapeutic cardiac catheterization&#xD;
  &#xD;
            -  ASA I and II&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ASA III or more than.&#xD;
  &#xD;
            -  Drug allergy.&#xD;
  &#xD;
            -  Any of contraindication for general anesthesia.&#xD;
  &#xD;
            -  Mental and neurological diseases.&#xD;
  &#xD;
            -  disapproval or dissatisfaction&#xD;
  &#xD;
            -  Liver disease&#xD;
  &#xD;
            -  Diabetic children&#xD;
  &#xD;
            -  Thyroid storm&#xD;
  &#xD;
            -  Sleep disorders&#xD;
  &#xD;
            -  Intake of antipsychotics.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mohamed kahloul, professor</last_name>
      <role>Study Chair</role>
      <affiliation>souse university</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hussein Hussein</last_name>
      <phone>009647811593388</phone>
      <email>hussein.hussein@alayen.edu.iq</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ministry of Health</name>
        <address>
          <city>Baghdad</city>
          <state>Thi-Qar</state>
          <zip>00964</zip>
          <country>Iraq</country>
        </address>
      </facility>
      <contact>
        <last_name>Abd-Alrahman Al-Batat</last_name>
        <phone>+9647830921522</phone>
        <email>Thiqarhealth@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Iraq</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Al-Azhar University</investigator_affiliation>
      <investigator_full_name>Hussein Ali</investigator_full_name>
      <investigator_title>lecturer in anesthesiology department</investigator_title>
    </responsible_party>
    <keyword>Melatonin, premedication, preoperative anxiety</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Melatonin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06031961
  org study id: Melatonin in PA
  nct id: NCT06031961
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The evaluation of oral melatonin efficacy as premedicant agent in pediatrics undergoing
        elective cardiac interventions is the primary outcomes of our trail.
  About 65 % of children whom undergoing surgery and anesthesia are suffering from keen anxiety
        and stress especially in the preoperative holding area. This situation mostly extends to the
        parents and this can worse the child response before surgery. The intensity of child anxiety
        had been reported to be a powerful predictor for incidence of hallucination in the recovery
        period and new-onset unpleasant behavioral changes such as nightmares and enuresis. In
        general, patients' preoperative anxiety if not controlled or reduced by premeditations, it
        can influence the surgical outcomes such as the postoperative pain, analgesic requirements,
        length of hospitality. Many of systemic physiological changes may be associated with the
        anxiety; such as elevated respiratory rate, elevated blood pressure, increased the heart rate
        and developing the risky of arrhythmia; all of these can be dilemmas and obstacles in the way
        of the anesthesiologist in choosing the appropriate method of anesthesia or the appropriate
        drugs for the starting and continuation of anesthesia. At the beginning of the eighties of
        the last century, the midazolam had been presented as the finest oral premedication agent
        which used in the pre-operative period for children to reduce the anxiety, and its quickly
        achieved wide acceptance as the preferred primer before induction of anesthesia. Rapid
        absorption during oral administration, multiple route administration and low incidence of
        nausea with its use when compared with other benzodiazepines, all these features helped to
        favor the midazolam for pre-operative use as a premedication in pediatrics. Despite the
        decent advantages that midazolam has in use before surgical interventions as a premedication
        agent, especially for children, it has some drawbacks that may affect the results of the
        surgical procedure and the anesthesia plan. Paradoxical reactions, interaction with opioids,
        overdue evacuation during the recovery time and capricious bioavailability are the most
        common drawbacks of midazolam in general. Some of these effects of midazolam had been shown
        to vary with patient age. In the presence of such drawbacks with the use of midazolam, the
        emergence of a suitable alternative may be widely accepted. Naturally, the
        N-acetyl-5-methoxy-tryptamine, which is also known as the Melatonin, is a biogenic amine
        which is firstly discovered in the middle of last century (1958) by Aaron B. Lerner in Yale
        University. After a while, the melatonin had been reported to be synthesized in animals,
        plants and even in unicellular organisms such as bacteria. In humans, the melatonin is mainly
        produced by the bovine pineal glands which is a small pine-cone shaped structure and located
        on the roof of the 3rd ventricle, deeply within the brain. In addition to production of
        melatonin; the main function of pineal gland; the gland also secrets some substances such as
        Oxytocin, Serotonin and Orexin in responding to influencing by neurotransmitters from neurons
        and nerve cells. The lymphocytes, bone marrow, eyes, and the gastrointestinal tract had been
        recently documented to a site production of melatonin hormone in human body.
  
        Sleep cycle, mood, memory dreaming, immune activity, learning fertility and reproduction are
        the common physiological activities which regulated mainly by the melatonin in humans, all of
        these functions are accomplished through direct stimulation or binding to melatonin
        receptors.
  
        European Medicines Agency had licensed the synthetic melatonin in form of tablets (2 mg) and
        (3 mg) in United Kingdom (UK) and Hungary. Also there is a licensed oral solution of 1mg/ml.
        The unlicensed synthetic melatonin is available in different forms from Kidmel® & Kidnaps®,
        Special Products Limited in the UK in liquid formulations and capsule formulation of 2 & 3
        mg.
  
        Many qualities of the chemical melatonin, which is mostly produced by the pineal gland, may
        help explain why it has cardio protective benefits. Melatonin may have receptor-mediated or
        receptor-independent protective effects. Ischemia/reperfusion (IR) injury has been shown to
        affect many organs, including the heart, liver, kidney, gut, testis, brain, and lung.
        Melatonin has been shown to offer numerous protective advantages. Melatonin's potent
        antioxidant qualities, as well as its capacity to encourage the synthesis of other
        antioxidants such as glutathione reductase, catalase, glutathione peroxidase, and superoxide
        dismutase, all contribute to its protective effects.
  
        As a result, it acts as both an indirect antioxidant and a free radical scavenger. Because
        melatonin receptors are found in the vasculature, it is possible that melatonin has local
        control over cardiovascular diseases. Furthermore, the amount of melatonin generated by
        persons suffering from coronary artery disease is inversely connected to the stage of the
        disease-the less melatonin produced, the more advanced the disease.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: preoperative anxiety
  time frame: 30 minutes before 2nd dose of premedication, 1 hour after 2nd dose premedication, At separation from parents, 5 minutes before induction of general anesthesia.
  description: Modified Yale Preoperative Anxiety Scale (mYPAS)
  measure: Sedation level
  time frame: 1 hour after 2nd dose premedication, At separation from parents, 5 minutes before induction of general anesthesia.
  description: The University of Michigan Sedation Scale (UMSS)
  arm group label: 1st group: Melatonin group
  arm group type: Active Comparator
  description: All children in this group have to receive 0.5 mg/kg of melatonin(maximum dose 20 mg) which will be administered orally on the night before surgery ( at 12 am) and immediately before 30 minutes before entering the catheterization room.
  arm group label: 2nd group: Placebo group
  arm group type: Placebo Comparator
  description: All children in this group have to receive a placebo which will be administered orally on the night before surgery and immediately before 30 minutes before entering the catheterization room.
  intervention type: Drug
  intervention name: melatonin
  description: We will premedicate the children whom involved in the 1st group with 0.5 mg/kg oral melatonin in the midnight before surgery and the dose will be repeated at morning before getting in the catheterization room
  arm group label: 1st group: Melatonin group
  arm group label: 2nd group: Placebo group
  other name: Placebo
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 12 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mohamed kahloul, professor
  role: Study Chair
  affiliation: souse university
  last name: Hussein Hussein
  phone: 009647811593388
  email: hussein.hussein@alayen.edu.iq
  facility: 
  contact: 
  country: Iraq
  responsible party type: Principal Investigator
  investigator affiliation: Al-Azhar University
  investigator full name: Hussein Ali
  investigator title: lecturer in anesthesiology department
  mesh term: Melatonin
  sharing ipd: No