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/NCT05990686</url>
    </required_header>
    <id_info>
      <org_study_id>9702/19-10-2022</org_study_id>
      <nct_id>NCT05990686</nct_id>
    </id_info>
    <brief_title>Paracetamol Plus Tramadol Versus Fentanyl in Day Case Surgeries</brief_title>
    <official_title>Preemptive Intravenous Paracetamol Plus Tramadol Versus Preemptive Intravenous Fentanyl in Day Case Surgeries</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zagazig University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zagazig University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Postoperative pain is an important problem, especially for day case surgeries. It has&#xD;
        negative effects on patient's hemodynamics and can cause delayed ambulation resulting in&#xD;
        prolonged duration of hospital stay and poor patient satisfaction.&#xD;
  &#xD;
        Multiple analgesic strategies have been proposed including NSAID, opioids, epidural&#xD;
        analgesia. Each of them has its limitations.&#xD;
  &#xD;
        In this study the investigators will compare between the effect of preemptive use of&#xD;
        paracetamol plus tramadol versus preemptive intravenous fentanyl in controlling postoperative&#xD;
        pain&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After routine pre-operative evaluation, standard monitors will be connected to the patients:&#xD;
        pulse oximetery, non invasive blood pressure and electrocardiogram and baseline parameter&#xD;
        will be recorded (heart rate, mean arterial pressure and peripheral oxygen saturation).&#xD;
        Intravenous (IV) line will be inserted for all patients, and IV fluid will be started.&#xD;
  &#xD;
        Patients will be allocated into two equal groups;&#xD;
  &#xD;
        Group (T) (n=66):&#xD;
  &#xD;
        Intravenous infusion of 15mg/kg paracetamol together with 1mg/kg tramadol will be started and&#xD;
        to be finished before starting of induction of anesthesia (induction agent will be Propofol&#xD;
        2mg/kg)&#xD;
  &#xD;
        Group ( F ) (n=66):&#xD;
  &#xD;
        Intravenous injection of 1microgram/kg fentanyl will be given to the patient followed by&#xD;
        induction agents ( Propofol 2mg/kg).&#xD;
  &#xD;
        In both groups intraoperative monitoring of heart rate (beat/min) and mean arterial blood&#xD;
        pressure (mm gh) will be documented.&#xD;
  &#xD;
        Postoperatively:&#xD;
  &#xD;
        In the recovery room and in the surgical ward patient's mean blood pressure and heart rate&#xD;
        will be measured and recorded at 1, 2, 4, 6, and 12 hours postoperatively. Also the&#xD;
        postoperative pain assessment for all patients will be done by an anesthesiologist&#xD;
        (independent observer) at 1, 2, 4, 6 and 12 hours after surgery based on visual analog scale&#xD;
        (VAS) ( a 10-cm line labeled with &quot;worst pain imaginable&quot; on the right border and &quot;no pain&quot;&#xD;
        on the left border). The patient is instructed to make a mark along the line to represent the&#xD;
        intensity of pain currently being experienced.&#xD;
  &#xD;
        Standard postoperative analgesia consisted of paracetamol 1gm i.v. after 6 hours. A rescue&#xD;
        analgesic diclofenac 75mg IV infusion will be applied to patients if their VAS score was ≥ 3&#xD;
        and if paracetamol had been administered less than 6 hours before. Time of first required&#xD;
        dose of rescue analgesic and total rescue analgesic consumption over the 24-h study period&#xD;
        will be documented.&#xD;
  &#xD;
        Rescue antiemetics will be given to any patient complaining of nausea and vomiting,&#xD;
        occurrence of other side effects including bradycardia or hypotension will be recorded and&#xD;
        managed (hypotension defined as a decrease in mean arterial pressure (MAP) of more than 20%&#xD;
        of baseline value and planned to be treated with crystalloid infusion and 5 mg bolus of&#xD;
        ephedrine, Bradycardia is considered if the heart rate (HR) went below 50 b/min and planned&#xD;
        to be managed with atropine 0.2-0.5 mg). Patient satisfaction and length of postoperative&#xD;
        hospital stay will also be recorded.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 10, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>postoperative analgesia</measure>
      <time_frame>immediately postoperative (0 hour), 1 hour, 2 hours , 4 hours, 6 hours and 12 hours</time_frame>
      <description>Assess quality of postoperative analgesia in both groups analogue score (VAS) scale where zero means no pain and ten means worst pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>mean arterial Blood pressure</measure>
      <time_frame>5 minutes after start of surgery (intraoperative) , immediately after surgery (0 hour) , 1 hour, 2 hours , 4 hours , 6 hours and 12 hours after surgery</time_frame>
      <description>Compare mean arterial blood pressure in (mm hg) between patients in both groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>rescue analgesic</measure>
      <time_frame>immediately after surgery (0 hour) , 1 hour, 2 hours , 4 hours , 6 hours and 12 hours after surgery</time_frame>
      <description>document the first time for the need of rescue analgesics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>side effects</measure>
      <time_frame>up to twenty four hours after surgery</time_frame>
      <description>document the incidence of side effects including: bradycardia, hypotension, nausea and vomiting</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>length of hospital stay</measure>
      <time_frame>up to twenty four hours after surgery</time_frame>
      <description>Compare the length of hospital stay in both groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart Rate</measure>
      <time_frame>5 minutes after start of surgery ( intraoperative), immediately after surgery (0 hour) , 1 hour, 2 hours , 4 hours , 6 hours and 12 hours after surgery</time_frame>
      <description>compare the heart rate in rate per minutes (rpm) between patients in both groups</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">132</enrollment>
    <condition>Post Operative Pain</condition>
    <arm_group>
      <arm_group_label>paracetamol plus tramadol</arm_group_label>
      <description>randomized selection of 66 adult patients</description>
    </arm_group>
    <arm_group>
      <arm_group_label>fentanyl</arm_group_label>
      <description>randomized selection of 66 adult patients</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tramadol Hydrochloride</intervention_name>
      <description>After routine pre-operative evaluation, standard monitors will be connected to the patients: pulse oximetery, noninvasive blood pressure and electrocardiogram and baseline parameter will be recorded (heart rate, mean arterial pressure and peripheral oxygen saturation). Intravenous (IV) line will be inserted for all patients, and IV fluid will be started.&#xD;
  Intravenous infusion of 15mg/kg paracetamol together with 1mg/kg tramadol will be started and to be finished before starting of induction of anaesthesia (induction agent will be Propofol 2mg/kg)</description>
      <arm_group_label>paracetamol plus tramadol</arm_group_label>
      <other_name>tramadol</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fentanyl injection</intervention_name>
      <description>After routine pre-operative evaluation, standard monitors will be connected to the patients: pulse oximetery, noninvasive blood pressure and electrocardiogram and baseline parameter will be recorded (heart rate, mean arterial pressure and peripheral oxygen saturation). Intravenous (IV) line will be inserted for all patients, and IV fluid will be started...Intravenous injection of 1microgram/kg fentanyl will be given to the patient followed by induction agents ( propofol 2mg/kg).&#xD;
  .</description>
      <arm_group_label>fentanyl</arm_group_label>
      <other_name>fentanyl</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          patients scheduled for a day case surgeries&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients scheduled for day case surgeries.&#xD;
  &#xD;
            -  Both sex&#xD;
  &#xD;
            -  Patient's age 21 - 60 years.&#xD;
  &#xD;
            -  Patients with ASA physical status I, II.&#xD;
  &#xD;
            -  BMI 25 - 30 kg m-2.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Uncooperative patients and patients with psychological problems.&#xD;
  &#xD;
            -  Patients with liver or renal impairment..&#xD;
  &#xD;
            -  Patients with history of allergy to drug used in the study.&#xD;
  &#xD;
            -  Patients with chronic pain.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>MICHAEL A shaker, lecturer</last_name>
      <role>Principal Investigator</role>
      <affiliation>Zagazig University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>michael A shaker, lecturer</last_name>
      <phone>01220647566</phone>
      <phone_ext>002</phone_ext>
      <email>michaeladelshaker@yahoo.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>salwa S el sherbeny, lecturer</last_name>
      <phone>01128595629</phone>
      <phone_ext>002</phone_ext>
      <email>dr_salwa86@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Zagazig University , Fuculty of Medicine</name>
        <address>
          <city>Zagazig</city>
          <state>Sharquia</state>
          <zip>7120730</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>sahar M el gammal, professor</last_name>
        <phone>01000089606</phone>
        <phone_ext>002</phone_ext>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zagazig University</investigator_affiliation>
      <investigator_full_name>Michael Adel Shaker</investigator_full_name>
      <investigator_title>lecturer of anesthesia and intensive care</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>Fentanyl</mesh_term>
      <mesh_term>Tramadol</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05990686
  org study id: 9702/19-10-2022
  nct id: NCT05990686
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Postoperative pain is an important problem, especially for day case surgeries. It has
        negative effects on patient's hemodynamics and can cause delayed ambulation resulting in
        prolonged duration of hospital stay and poor patient satisfaction.
  
        Multiple analgesic strategies have been proposed including NSAID, opioids, epidural
        analgesia. Each of them has its limitations.
  
        In this study the investigators will compare between the effect of preemptive use of
        paracetamol plus tramadol versus preemptive intravenous fentanyl in controlling postoperative
        pain
  After routine pre-operative evaluation, standard monitors will be connected to the patients:
        pulse oximetery, non invasive blood pressure and electrocardiogram and baseline parameter
        will be recorded (heart rate, mean arterial pressure and peripheral oxygen saturation).
        Intravenous (IV) line will be inserted for all patients, and IV fluid will be started.
  
        Patients will be allocated into two equal groups;
  
        Group (T) (n=66):
  
        Intravenous infusion of 15mg/kg paracetamol together with 1mg/kg tramadol will be started and
        to be finished before starting of induction of anesthesia (induction agent will be Propofol
        2mg/kg)
  
        Group ( F ) (n=66):
  
        Intravenous injection of 1microgram/kg fentanyl will be given to the patient followed by
        induction agents ( Propofol 2mg/kg).
  
        In both groups intraoperative monitoring of heart rate (beat/min) and mean arterial blood
        pressure (mm gh) will be documented.
  
        Postoperatively:
  
        In the recovery room and in the surgical ward patient's mean blood pressure and heart rate
        will be measured and recorded at 1, 2, 4, 6, and 12 hours postoperatively. Also the
        postoperative pain assessment for all patients will be done by an anesthesiologist
        (independent observer) at 1, 2, 4, 6 and 12 hours after surgery based on visual analog scale
        (VAS) ( a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain"
        on the left border). The patient is instructed to make a mark along the line to represent the
        intensity of pain currently being experienced.
  
        Standard postoperative analgesia consisted of paracetamol 1gm i.v. after 6 hours. A rescue
        analgesic diclofenac 75mg IV infusion will be applied to patients if their VAS score was ≥ 3
        and if paracetamol had been administered less than 6 hours before. Time of first required
        dose of rescue analgesic and total rescue analgesic consumption over the 24-h study period
        will be documented.
  
        Rescue antiemetics will be given to any patient complaining of nausea and vomiting,
        occurrence of other side effects including bradycardia or hypotension will be recorded and
        managed (hypotension defined as a decrease in mean arterial pressure (MAP) of more than 20%
        of baseline value and planned to be treated with crystalloid infusion and 5 mg bolus of
        ephedrine, Bradycardia is considered if the heart rate (HR) went below 50 b/min and planned
        to be managed with atropine 0.2-0.5 mg). Patient satisfaction and length of postoperative
        hospital stay will also be recorded.
  observational model: Case-Control
  time perspective: Prospective
  measure: postoperative analgesia
  time frame: immediately postoperative (0 hour), 1 hour, 2 hours , 4 hours, 6 hours and 12 hours
  description: Assess quality of postoperative analgesia in both groups analogue score (VAS) scale where zero means no pain and ten means worst pain
  measure: mean arterial Blood pressure
  time frame: 5 minutes after start of surgery (intraoperative) , immediately after surgery (0 hour) , 1 hour, 2 hours , 4 hours , 6 hours and 12 hours after surgery
  description: Compare mean arterial blood pressure in (mm hg) between patients in both groups
  measure: rescue analgesic
  time frame: immediately after surgery (0 hour) , 1 hour, 2 hours , 4 hours , 6 hours and 12 hours after surgery
  description: document the first time for the need of rescue analgesics
  measure: side effects
  time frame: up to twenty four hours after surgery
  description: document the incidence of side effects including: bradycardia, hypotension, nausea and vomiting
  measure: length of hospital stay
  time frame: up to twenty four hours after surgery
  description: Compare the length of hospital stay in both groups
  measure: Heart Rate
  time frame: 5 minutes after start of surgery ( intraoperative), immediately after surgery (0 hour) , 1 hour, 2 hours , 4 hours , 6 hours and 12 hours after surgery
  description: compare the heart rate in rate per minutes (rpm) between patients in both groups
  arm group label: paracetamol plus tramadol
  description: randomized selection of 66 adult patients
  arm group label: fentanyl
  description: randomized selection of 66 adult patients
  intervention type: Drug
  intervention name: Tramadol Hydrochloride
  description: After routine pre-operative evaluation, standard monitors will be connected to the patients: pulse oximetery, noninvasive blood pressure and electrocardiogram and baseline parameter will be recorded (heart rate, mean arterial pressure and peripheral oxygen saturation). Intravenous (IV) line will be inserted for all patients, and IV fluid will be started.
  Intravenous infusion of 15mg/kg paracetamol together with 1mg/kg tramadol will be started and to be finished before starting of induction of anaesthesia (induction agent will be Propofol 2mg/kg)
  arm group label: paracetamol plus tramadol
  other name: tramadol
  intervention type: Drug
  intervention name: Fentanyl injection
  description: After routine pre-operative evaluation, standard monitors will be connected to the patients: pulse oximetery, noninvasive blood pressure and electrocardiogram and baseline parameter will be recorded (heart rate, mean arterial pressure and peripheral oxygen saturation). Intravenous (IV) line will be inserted for all patients, and IV fluid will be started...Intravenous injection of 1microgram/kg fentanyl will be given to the patient followed by induction agents ( propofol 2mg/kg).
  .
  arm group label: fentanyl
  other name: fentanyl
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: MICHAEL A shaker, lecturer
  role: Principal Investigator
  affiliation: Zagazig University
  last name: michael A shaker, lecturer
  phone: 01220647566
  phone ext: 002
  email: michaeladelshaker@yahoo.com
  last name: salwa S el sherbeny, lecturer
  phone: 01128595629
  phone ext: 002
  email: dr_salwa86@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Zagazig University
  investigator full name: Michael Adel Shaker
  investigator title: lecturer of anesthesia and intensive care
  mesh term: Pain, Postoperative
  mesh term: Fentanyl
  mesh term: Tramadol