<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/NCT04467177</url>
  </required_header>
  <id_info>
    <org_study_id>18122019</org_study_id>
    <nct_id>NCT04467177</nct_id>
  </id_info>
  <brief_title>Analgesic Effect of Oral Glucose in Neonates</brief_title>
  <official_title>Efficacy of Oral Glucose in Pain Alleviation Among Healthy Term Neonates Undergoing Circumcision</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makassed General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makassed General Hospital</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>
      Background: Male circumcision is one of the oldest and most common operations performed all&#xD;
      over the world. It can be performed at different ages, using different surgical techniques,&#xD;
      for different religious, cultural and medical reasons. It was thought that the newborn baby&#xD;
      does not experience pain because of incompletely developed nervous system. However, it has&#xD;
      been shown that neurological system known to be associated with pain transmission and&#xD;
      modulation, is intact and functional.&#xD;
&#xD;
      OBJECTIVE: Our objective is to determine if a 30% glucose solution would reduce pain after&#xD;
      circumcision compared with normal saline.&#xD;
&#xD;
      STUDY DESIGN: This is a randomized placebo-controlled double-blinded clinical trial.&#xD;
&#xD;
      POPULATION: We will include full term neonates, who will be recruited from the inpatient&#xD;
      nursery at Makassed General Hospital over a 1-year period.&#xD;
&#xD;
      OUTCOME MEASURE: The primary outcome is to assess efficacy of 30% glucose on pain measured&#xD;
      using the Neonatal Infant Pain Score.&#xD;
&#xD;
      Secondary outcome is to assess effect of 30% glucose oh physiologic parameters&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>Pain will be assessed 1 minute before the procedure and during the procedure</time_frame>
    <description>Pain response will be assessed utilizing the Neonatal Infant Pain Scale. The total pain score ranges from 0 to 10. Scores less than or equal to 3 indicate no pain while scores greater than 3 indicate pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>2 minutes before the procedure, during the procedure and one minute after the procedure</time_frame>
    <description>Heart rate (beats per minute) will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory rate</measure>
    <time_frame>2 minutes before the procedure, during the procedure and one minute after the procedure</time_frame>
    <description>Respiratory rate (breaths per minute) will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation</measure>
    <time_frame>2 minutes before the procedure, during the procedure and one minute after the procedure</time_frame>
    <description>Oxygen saturation (in percent) will be recorded</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Glucose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neonates will receive 30% oral glucose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Neonates will receive sterile water</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>30% glucose</intervention_name>
    <description>Male neonates will receive 2 ml of 30% glucose two minutes prior to circumcision</description>
    <arm_group_label>Glucose group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Male neonates will receive 2 ml of sterile water two minutes prior to circumcision</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Estimated gestational age: 37 weeks-42 weeks&#xD;
&#xD;
          -  Birth weight: 2500 grams-4000 grams&#xD;
&#xD;
          -  Apgar scores a minimum of 7 at 1 and 5 minutes respectively&#xD;
&#xD;
          -  Heart rate between 100 and 160 per minutes&#xD;
&#xD;
          -  Blood O2 saturation of at least 95%&#xD;
&#xD;
          -  No recognized congenital abnormalities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  They were transferred to the neonatal intensive care unit (NICU)&#xD;
&#xD;
          -  They required respiratory support&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amal Naous, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Makassed General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amal Naous, MD</last_name>
    <phone>+9611636000</phone>
    <phone_ext>6317</phone_ext>
    <email>amalnaous@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Makassed General Hospital</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amal Naous, MD</last_name>
      <phone>+9611636000</phone>
      <phone_ext>6941</phone_ext>
      <email>amalnaous@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Makassed General Hospital</investigator_affiliation>
    <investigator_full_name>Amal Naous</investigator_full_name>
    <investigator_title>Pediatrician</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04467177
org study id: 18122019
nct id: NCT04467177
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background: Male circumcision is one of the oldest and most common operations performed all
      over the world. It can be performed at different ages, using different surgical techniques,
      for different religious, cultural and medical reasons. It was thought that the newborn baby
      does not experience pain because of incompletely developed nervous system. However, it has
      been shown that neurological system known to be associated with pain transmission and
      modulation, is intact and functional.

      OBJECTIVE: Our objective is to determine if a 30% glucose solution would reduce pain after
      circumcision compared with normal saline.

      STUDY DESIGN: This is a randomized placebo-controlled double-blinded clinical trial.

      POPULATION: We will include full term neonates, who will be recruited from the inpatient
      nursery at Makassed General Hospital over a 1-year period.

      OUTCOME MEASURE: The primary outcome is to assess efficacy of 30% glucose on pain measured
      using the Neonatal Infant Pain Score.

      Secondary outcome is to assess effect of 30% glucose oh physiologic parameters
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain score
time frame: Pain will be assessed 1 minute before the procedure and during the procedure
description: Pain response will be assessed utilizing the Neonatal Infant Pain Scale. The total pain score ranges from 0 to 10. Scores less than or equal to 3 indicate no pain while scores greater than 3 indicate pain.
measure: Heart rate
time frame: 2 minutes before the procedure, during the procedure and one minute after the procedure
description: Heart rate (beats per minute) will be recorded
measure: Respiratory rate
time frame: 2 minutes before the procedure, during the procedure and one minute after the procedure
description: Respiratory rate (breaths per minute) will be recorded
measure: Oxygen saturation
time frame: 2 minutes before the procedure, during the procedure and one minute after the procedure
description: Oxygen saturation (in percent) will be recorded
arm group label: Glucose group
arm group type: Experimental
description: Neonates will receive 30% oral glucose
arm group label: Placebo group
arm group type: Placebo Comparator
description: Neonates will receive sterile water
intervention type: Other
intervention name: 30% glucose
description: Male neonates will receive 2 ml of 30% glucose two minutes prior to circumcision
arm group label: Glucose group
intervention type: Other
intervention name: Placebo
description: Male neonates will receive 2 ml of sterile water two minutes prior to circumcision
arm group label: Placebo group
criteria: 
gender: Male
minimum age: 1 Day
maximum age: 28 Days
healthy volunteers: No
last name: Amal Naous, MD
role: Principal Investigator
affiliation: Makassed General Hospital
last name: Amal Naous, MD
phone: +9611636000
phone ext: 6317
email: amalnaous@hotmail.com
facility: 
status: Recruiting
contact: 
country: Lebanon
responsible party type: Principal Investigator
investigator affiliation: Makassed General Hospital
investigator full name: Amal Naous
investigator title: Pediatrician