<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/NCT02995304</url>
  </required_header>
  <id_info>
    <org_study_id>03/IRB/2016</org_study_id>
    <nct_id>NCT02995304</nct_id>
  </id_info>
  <brief_title>Preemptive Analgesia for Post Tonsillectomy Pain With IV Morphine in Children</brief_title>
  <official_title>Preemptive Analgesia for Post Tonsillectomy Pain With IV Morphine in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Soliman Fakeeh Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dr. Soliman Fakeeh Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this double blind study, after taking an informed consent, 60 children aged between 7 and&#xD;
      12 years old assigned for tonsillectomy with or without adenoidectomy will be randomly&#xD;
      divided into three groups. The first group 30 children will receive 0.025 mg/kg midazolam IV&#xD;
      followed by 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision. In&#xD;
      the second group30 children who will receive the same dose of midazolam followed by saline&#xD;
      premedication. All groups will be compared for pain score using visual analog scale (VAS)&#xD;
      after recovery and hourly for 8 hours and during first drinking. Heart rate (HR), blood&#xD;
      pressure and peripheral oxygen saturation (SPO2) will be recorded before premedication, every&#xD;
      10 min after premedication then every 5 min during and after anesthesia. 6 point sedation&#xD;
      score and 4 points behavioral score will be monitored every 5 min after sedation. Four-point&#xD;
      wake-up score will be recorded every 5 min. Time of first analgesic requirement and total&#xD;
      morphine consumption during the first post-operative 8 hours will be recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tonsillectomy is a minor procedure but it causes sever post-operative pain. This pain is&#xD;
      difficult to be controlled with opioids because the fear from respiratory depression in&#xD;
      pediatric age group with postoperative oral bleeding. The World Heath Organization (WHO)&#xD;
      guidelines clearly state that fear and lack of knowledge regarding the use of opioids in&#xD;
      children should not be a barrier for effective analgesia (1). ). However, these procedures&#xD;
      are usually day case and the use of oral morphine at home may be risky in some groups of this&#xD;
      population (2). So decrease the analgesic requirements following these procedures will&#xD;
      increase both satisfaction and safety. The trials for the use of morphine as a preemptive&#xD;
      analgesia, in awake patient, have been limited to intramuscular (IM) or oral use which has a&#xD;
      slow onset and unpredictable absorption. The use of preoperative IV morphine is not popular&#xD;
      because of the unpleasant sensations following its administration. I will use small dose&#xD;
      midazolam 0.025 gm/kg before morphine to prevent this sensation. In this double blind study,&#xD;
      after taking an informed consent, 60 children aged between 7 and 12 years old assigned for&#xD;
      tonsillectomy with or without adenoidectomy will be randomly divided into three groups. The&#xD;
      first group 30 children will receive 0.025 mg/kg midazolam IV followed by 0.1 mg/kg morphine&#xD;
      as a premedication 20 to 30 min before surgical incision. In the second group30 children who&#xD;
      will receive the same dose of midazolam followed by saline premedication. Inhalational&#xD;
      anesthesia with sevoflurane and nitrous oxide will be used in all patients. Exclusion&#xD;
      criteria are those with bronchial asthma, obstructive sleep apnea, allergy to medications&#xD;
      used in the study and those who are unfit for surgery or anesthesia for any reason like&#xD;
      coagulopathy or chest infection.&#xD;
&#xD;
      All groups will be compared for pain score using visual analog scale (VAS) after recovery and&#xD;
      hourly for 8 hours and during first drinking. HR, blood pressure and SPO2 will be recorded&#xD;
      before premedication, every 10 min after premedication then every 5 min during and after&#xD;
      anesthesia. 6 point sedation score and 4 points behavioral score will be monitored every 5&#xD;
      min after sedation. Four-point wake-up score will be recorded every 5 min. Time of first&#xD;
      analgesic requirement and total morphine consumption during the first post-operative 8 hours&#xD;
      will be recorded. Base line oxygen saturation, incidence of postoperative hypoxia, bleeding,&#xD;
      nausea and vomiting will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <primary_completion_date type="Anticipated">March 2017</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative morphine requirement</measure>
    <time_frame>8 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative nonsteroidal analgesic requirements</measure>
    <time_frame>two days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative behavior score</measure>
    <time_frame>15 to 30 minutes</time_frame>
    <description>B. Behavior scores:&#xD;
1 - Calm and cooperative 2 - Anxious but can be reassured 3 - Anxious and can not be reassured 4 - Crying, or resisting C. Wake-up behavior scores 1 - Calm and cooperative 2 - Not calm but could be easily calmed 3 - Not easily calmed, moderately agitated or restless 4 - Combative, excited, disoriented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wake-up behavior scores</measure>
    <time_frame>30 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Preoperative Sedation</condition>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Morphine and Midazolam premedication</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 children will receive 0.025 mg/kg midazolam IV followed by 0.1 mg/kg morphine 20 to 30 min before surgical incision.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Midazolam only premedication</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 children who will receive 0.025 mg/kg midazolam IV followed by saline 20 to 30 min before surgical incision.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine premedication</intervention_name>
    <description>30 children will 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision.</description>
    <arm_group_label>Morphine and Midazolam premedication</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam premedication</intervention_name>
    <description>All children who will receive 0.025 mg/kg midazolam IV as a premedication 20 to 30 min before surgical incision.</description>
    <arm_group_label>Midazolam only premedication</arm_group_label>
    <arm_group_label>Morphine and Midazolam premedication</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline premedication (placebo)</intervention_name>
    <description>30 children in midazolam only group will receive saline after midazolam</description>
    <arm_group_label>Midazolam only premedication</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Tonsillectomy procedures in&#xD;
&#xD;
          -  Children aged between 7 and 12 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Bronchial asthma, obstructive sleep apnea, allergy to medications used in the study and&#xD;
        those who are unfit for surgery or anesthesia for any reason like coagulopathy or chest&#xD;
        infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amr A Keera, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Doctor Soliman Fakeeh Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amr A Keera, MD</last_name>
    <phone>00966544639362</phone>
    <email>amrkeera@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Doctor Soliman Fakeeh Hospital</name>
      <address>
        <city>Jeddah</city>
        <zip>21461</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <contact>
      <last_name>Amr A Keera, MD</last_name>
      <phone>00966544639362</phone>
      <email>amrkeera@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dr. Soliman Fakeeh Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Amr Aly Ismail Keera</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Morphine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02995304
org study id: 03/IRB/2016
nct id: NCT02995304
lead sponsor: 
has dmc: Yes
In this double blind study, after taking an informed consent, 60 children aged between 7 and
      12 years old assigned for tonsillectomy with or without adenoidectomy will be randomly
      divided into three groups. The first group 30 children will receive 0.025 mg/kg midazolam IV
      followed by 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision. In
      the second group30 children who will receive the same dose of midazolam followed by saline
      premedication. All groups will be compared for pain score using visual analog scale (VAS)
      after recovery and hourly for 8 hours and during first drinking. Heart rate (HR), blood
      pressure and peripheral oxygen saturation (SPO2) will be recorded before premedication, every
      10 min after premedication then every 5 min during and after anesthesia. 6 point sedation
      score and 4 points behavioral score will be monitored every 5 min after sedation. Four-point
      wake-up score will be recorded every 5 min. Time of first analgesic requirement and total
      morphine consumption during the first post-operative 8 hours will be recorded.
Tonsillectomy is a minor procedure but it causes sever post-operative pain. This pain is
      difficult to be controlled with opioids because the fear from respiratory depression in
      pediatric age group with postoperative oral bleeding. The World Heath Organization (WHO)
      guidelines clearly state that fear and lack of knowledge regarding the use of opioids in
      children should not be a barrier for effective analgesia (1). ). However, these procedures
      are usually day case and the use of oral morphine at home may be risky in some groups of this
      population (2). So decrease the analgesic requirements following these procedures will
      increase both satisfaction and safety. The trials for the use of morphine as a preemptive
      analgesia, in awake patient, have been limited to intramuscular (IM) or oral use which has a
      slow onset and unpredictable absorption. The use of preoperative IV morphine is not popular
      because of the unpleasant sensations following its administration. I will use small dose
      midazolam 0.025 gm/kg before morphine to prevent this sensation. In this double blind study,
      after taking an informed consent, 60 children aged between 7 and 12 years old assigned for
      tonsillectomy with or without adenoidectomy will be randomly divided into three groups. The
      first group 30 children will receive 0.025 mg/kg midazolam IV followed by 0.1 mg/kg morphine
      as a premedication 20 to 30 min before surgical incision. In the second group30 children who
      will receive the same dose of midazolam followed by saline premedication. Inhalational
      anesthesia with sevoflurane and nitrous oxide will be used in all patients. Exclusion
      criteria are those with bronchial asthma, obstructive sleep apnea, allergy to medications
      used in the study and those who are unfit for surgery or anesthesia for any reason like
      coagulopathy or chest infection.

      All groups will be compared for pain score using visual analog scale (VAS) after recovery and
      hourly for 8 hours and during first drinking. HR, blood pressure and SPO2 will be recorded
      before premedication, every 10 min after premedication then every 5 min during and after
      anesthesia. 6 point sedation score and 4 points behavioral score will be monitored every 5
      min after sedation. Four-point wake-up score will be recorded every 5 min. Time of first
      analgesic requirement and total morphine consumption during the first post-operative 8 hours
      will be recorded. Base line oxygen saturation, incidence of postoperative hypoxia, bleeding,
      nausea and vomiting will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Postoperative morphine requirement
time frame: 8 hours
measure: Postoperative nonsteroidal analgesic requirements
time frame: two days
measure: Preoperative behavior score
time frame: 15 to 30 minutes
description: B. Behavior scores:
1 - Calm and cooperative 2 - Anxious but can be reassured 3 - Anxious and can not be reassured 4 - Crying, or resisting C. Wake-up behavior scores 1 - Calm and cooperative 2 - Not calm but could be easily calmed 3 - Not easily calmed, moderately agitated or restless 4 - Combative, excited, disoriented.
measure: Wake-up behavior scores
time frame: 30 minutes
arm group label: Morphine and Midazolam premedication
arm group type: Active Comparator
description: 30 children will receive 0.025 mg/kg midazolam IV followed by 0.1 mg/kg morphine 20 to 30 min before surgical incision.
arm group label: Midazolam only premedication
arm group type: Active Comparator
description: 30 children who will receive 0.025 mg/kg midazolam IV followed by saline 20 to 30 min before surgical incision.
intervention type: Drug
intervention name: Morphine premedication
description: 30 children will 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision.
arm group label: Morphine and Midazolam premedication
intervention type: Drug
intervention name: Midazolam premedication
description: All children who will receive 0.025 mg/kg midazolam IV as a premedication 20 to 30 min before surgical incision.
arm group label: Midazolam only premedication
arm group label: Morphine and Midazolam premedication
intervention type: Drug
intervention name: Saline premedication (placebo)
description: 30 children in midazolam only group will receive saline after midazolam
arm group label: Midazolam only premedication
criteria: 
gender: All
minimum age: 7 Years
maximum age: 12 Years
healthy volunteers: No
last name: Amr A Keera, MD
role: Principal Investigator
affiliation: Doctor Soliman Fakeeh Hospital
last name: Amr A Keera, MD
phone: 00966544639362
email: amrkeera@yahoo.com
facility: 
contact: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: Dr. Soliman Fakeeh Hospital
investigator full name: Dr. Amr Aly Ismail Keera
investigator title: Principle investigator
mesh term: Pain, Postoperative
mesh term: Midazolam
mesh term: Morphine
sharing ipd: No