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/NCT05997134</url>
    </required_header>
    <id_info>
      <org_study_id>36264MS44/1/23</org_study_id>
      <nct_id>NCT05997134</nct_id>
    </id_info>
    <brief_title>Three Regimens of Ketamine Infusion in Complex Regional Pain Syndrome</brief_title>
    <official_title>Assessment of Three Regimens of Ketamine Infusion in Complex Regional Pain Syndrome: Randomized Prospective Comparative Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tanta University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To evaluate the efficacy of three regimens of sub anesthetic dose of ketamine infusion in&#xD;
        relieving chronic refractory pain in patients with complex regional pain syndrome&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Ketamine N-methyl-D-aspartate (NMDA) receptor blocker that has recently been studied for its&#xD;
        analgesic effect is a phencyclidine or phenyl cyclohexyl piperidine (PCP) derivative that&#xD;
        initially became commercially available for human use in 1970 as a rapid-acting intravenous&#xD;
        (IV) anesthetic. It is currently classified by the Food and Drug Administration (FDA) as an&#xD;
        anesthetic induction agent in doses ranging from 1 to 4.5 mg/kg.&#xD;
  &#xD;
        Ketamine has proven to be a desirable drug, despite of its induction dissociative effects and&#xD;
        abuse potential. It is favorable due to its short half-life and lack of clinically&#xD;
        significant respiratory depression. In addition to its anesthetic effects, ketamine has&#xD;
        analgesic, anti-inflammatory, and antidepressant activities.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 30, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <phase>Phase 4</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>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>degree of chronic pain reduction</measure>
      <time_frame>up to 3 months post infusion</time_frame>
      <description>using Brief Pain Inventory short form (BPI-SF) questionnaire. It is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Reduction of the degree of chronic pain score</measure>
      <time_frame>up to 3 months post infusion</time_frame>
      <description>Numerical rating scales (NRS) is an 11-point scale for patient self-reporting of pain. It is based solely on the ability to perform activities of daily living (ADLs) with 0 being &quot;no pain&quot; and 10 being &quot;the worst pain imaginable&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Side effects</measure>
      <time_frame>up to 3 months post infusion</time_frame>
      <description>Headache, Nausea and vomiting</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Ketamine Infusion</condition>
    <condition>Complex Regional Pain Syndromes</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h) at post anesthetic care unit(PACU) over 6 hours for 3days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h ) at post anesthetic care unit(PACU) over 6 hours for 5 days .</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group C</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h ) at post anesthetic care unit(PACU) over 6 hours for 7 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ketamine</intervention_name>
      <description>patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h) at post anesthetic care unit(PACU) over 6 hours for 3days .</description>
      <arm_group_label>Group A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ketamine</intervention_name>
      <description>patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h ) at post anesthetic care unit(PACU) over 6 hours for 5 days</description>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ketamine</intervention_name>
      <description>patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h ) at post anesthetic care unit(PACU) over 6 hours for 7 days</description>
      <arm_group_label>Group C</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged more than 21 years old of both sexes with American Standards Association&#xD;
               I ,II.&#xD;
  &#xD;
            -  Patients diagnosed as ( CRPS) based on Budapest criteria&#xD;
  &#xD;
            -  The average daily pain intensity required on (NRS) is 7 or more for at least 3 months&#xD;
               despite of standard therapy which includes: (pharmacologic therapy as non steroidal&#xD;
               anti- inflammatory drugs (NSAIDs), antiepileptic (AEDs), antidepressants), as well as&#xD;
               physical therapy and psychiatric care&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients refusal&#xD;
  &#xD;
            -  Patients with unstable psychological or psychiatric conditions, including : untreated&#xD;
               bipolar disorder, post-traumatic stress disorder, major depression , severe&#xD;
               personality disorder and psychotic illness.&#xD;
  &#xD;
            -  Patients have recently undergone major interventional pain procedures, such as nerve&#xD;
               blocks or implantable therapies within 3 months of enrollment.&#xD;
  &#xD;
            -  Patients with known drug dependency or substance use disorder specifically related to&#xD;
               ketamine or other psycho-stimulant drugs.&#xD;
  &#xD;
            -  Patients with previous severe reactions, contraindication or allergy to ketamine.&#xD;
  &#xD;
            -  Patients with cardiovascular disease (hypertension, arrhythmia), hepatic, renal or&#xD;
               other organ impairment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Tanta University</name>
        <address>
          <city>Tanta</city>
          <state>El-garbia</state>
          <zip>31527</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Aml M Abo elsafa, MBBCh</last_name>
        <phone>+20 101 260 2853</phone>
        <email>amlabouelsafa67@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Ashraf A Alzeftawy, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Mohamed A Afandy, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hesham I El Tatawy, Msc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Aml Magdy Abo Elsafa</investigator_full_name>
      <investigator_title>resident of anesthesiology, surgical intensive care and pain medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Complex Regional Pain Syndromes</mesh_term>
      <mesh_term>Reflex Sympathetic Dystrophy</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Somatoform Disorders</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ketamine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data will be available upon a reasonable request from the corresponding author after the end of study for one year.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>after the end of study for one year</ipd_time_frame>
      <ipd_access_criteria>The data will be available upon a reasonable request from the corresponding author</ipd_access_criteria>
    </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/NCT05997134
  org study id: 36264MS44/1/23
  nct id: NCT05997134
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the efficacy of three regimens of sub anesthetic dose of ketamine infusion in
        relieving chronic refractory pain in patients with complex regional pain syndrome
  Ketamine N-methyl-D-aspartate (NMDA) receptor blocker that has recently been studied for its
        analgesic effect is a phencyclidine or phenyl cyclohexyl piperidine (PCP) derivative that
        initially became commercially available for human use in 1970 as a rapid-acting intravenous
        (IV) anesthetic. It is currently classified by the Food and Drug Administration (FDA) as an
        anesthetic induction agent in doses ranging from 1 to 4.5 mg/kg.
  
        Ketamine has proven to be a desirable drug, despite of its induction dissociative effects and
        abuse potential. It is favorable due to its short half-life and lack of clinically
        significant respiratory depression. In addition to its anesthetic effects, ketamine has
        analgesic, anti-inflammatory, and antidepressant activities.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: degree of chronic pain reduction
  time frame: up to 3 months post infusion
  description: using Brief Pain Inventory short form (BPI-SF) questionnaire. It is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale.
  measure: Reduction of the degree of chronic pain score
  time frame: up to 3 months post infusion
  description: Numerical rating scales (NRS) is an 11-point scale for patient self-reporting of pain. It is based solely on the ability to perform activities of daily living (ADLs) with 0 being "no pain" and 10 being "the worst pain imaginable"
  measure: Side effects
  time frame: up to 3 months post infusion
  description: Headache, Nausea and vomiting
  arm group label: Group A
  arm group type: Experimental
  description: patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h) at post anesthetic care unit(PACU) over 6 hours for 3days
  arm group label: Group B
  arm group type: Experimental
  description: patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h ) at post anesthetic care unit(PACU) over 6 hours for 5 days .
  arm group label: Group C
  arm group type: Experimental
  description: patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h ) at post anesthetic care unit(PACU) over 6 hours for 7 days
  intervention type: Drug
  intervention name: Ketamine
  description: patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h) at post anesthetic care unit(PACU) over 6 hours for 3days .
  arm group label: Group A
  intervention type: Drug
  intervention name: Ketamine
  description: patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h ) at post anesthetic care unit(PACU) over 6 hours for 5 days
  arm group label: Group B
  intervention type: Drug
  intervention name: Ketamine
  description: patients will receive ketamine parenteral infusion (0.35 mg/kg/h or maximum 24mg/h ) at post anesthetic care unit(PACU) over 6 hours for 7 days
  arm group label: Group C
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 40 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: Aml Magdy Abo Elsafa
  investigator title: resident of anesthesiology, surgical intensive care and pain medicine
  mesh term: Complex Regional Pain Syndromes
  mesh term: Reflex Sympathetic Dystrophy
  mesh term: Syndrome
  mesh term: Somatoform Disorders
  mesh term: Ketamine
  sharing ipd: Yes
  ipd description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
  ipd info type: Study Protocol
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: after the end of study for one year
  ipd access criteria: The data will be available upon a reasonable request from the corresponding author