<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/NCT04418674</url>
  </required_header>
  <id_info>
    <org_study_id>IRC/1597/019</org_study_id>
    <nct_id>NCT04418674</nct_id>
  </id_info>
  <brief_title>Comparison of Analgesic Effectiveness of Intravenous Ketamine and Fentanyl for Spinal Anesthesia is Sitting Position in Patients With Proximal Femur Fracture</brief_title>
  <official_title>Comparison of Analgesic Effectiveness of Intravenous Ketamine and Fentanyl for Spinal Anesthesia is Sitting Position in Patients With Proximal Femur Fracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jenny Bajracharya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>B.P. Koirala Institute of Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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>
      This is a prospective comparative study which will be conducted in patients with proximal&#xD;
      femur fracture undergoing operative interventions under subarachnoid block in sitting&#xD;
      position. Ketamine group will receive 0.3mg/kg intravenously and Fentanyl group will receive&#xD;
      1.5mcg/kg before changing the position from supine to sitting for subarachnoid block.&#xD;
      Analgesic effectiveness of the two drugs will be compared by Numeric Rating Scale for pain.&#xD;
&#xD;
      Research hypothesis (Null hypothesis) There is no difference in analgesic effectiveness,&#xD;
      patient satisfaction, spinal performance and occurrence of adverse effects between&#xD;
      Intravenous ketamine and intravenous fentanyl in patients with proximal femur fracture.&#xD;
&#xD;
      Alternate hypothesis Intravenous Ketamine in patients with proximal femur fracture improves&#xD;
      the level of analgesia, patient satisfaction, spinal performance and occurrence of adverse&#xD;
      effects when compared to intravenous fentanyl.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Femur fracture is a common orthopedic problem following trauma in patients of all ages. It is&#xD;
      a painful bone injury and is associated with severe pain and distress during preoperative&#xD;
      period. Surgical repair is most commonly done in subarachnoid block. However, moving the&#xD;
      patient for optimal positioning for spinal needle placement in subarachnoid space leads to&#xD;
      severe pain. Adequate analgesia not only improves patient's comfort but has also been shown&#xD;
      to improve positioning for subarachnoid block. Several analgesic modalities have been used to&#xD;
      decrease movement evoked pain in these patients including the use of intravenous analgesics&#xD;
      and blocks. However, there are only few studies comparing intravenous analgesics that&#xD;
      alleviated the pain that occurs when changing position for subarachnoid block.&#xD;
&#xD;
      Patient enrollment will be done by the primary investigator one day prior to the surgery. All&#xD;
      eligible patients with American Society of Anesthesiologist Physical Status I, II fulfilling&#xD;
      the inclusion criteria will be informed about the study and written consent will be obtained&#xD;
      in pre operative visit, one day prior to the surgery, in the orthopedic in-patient ward.&#xD;
&#xD;
      All patients will be kept nil per oral for 6 hours for solid, heavy meal, 4 hours for light&#xD;
      meal and 2 hours for clear liquid. All the patients will be pre-medicated with Tab Lorazepam&#xD;
      1mg (&lt;50kg) and 2mg (&gt;50kg) orally the night before and in the morning of the surgery.&#xD;
&#xD;
      On the day of surgery, randomization will be done in pre operative holding area and the&#xD;
      patient will be transferred to the operation theatre in trolley maintaining the skeletal&#xD;
      traction. All standard monitoring devices like electrocardiogram, non-invasive blood pressure&#xD;
      monitoring and pulse oximeter will be attached. Standard anesthesia monitoring including&#xD;
      3-lead electrocardiography, oxygen saturation(Spo2), blood pressure(BP) and heart rate(HR)&#xD;
      will be done.Baseline Numeric Rating Scale(NRS) for pain at rest and movement will be&#xD;
      assessed (movement is defined at 5 cm active vertical movement of the limb).&#xD;
&#xD;
      An intravenous line will be secured with 18 gauge intavenous cannula in the dorsum of hand.&#xD;
      Pre-hydration will be started with Ringer's Lactate solution at 5ml/kg/hour.&#xD;
&#xD;
      Dose of the drug required according to the body weight will be calculated and prepared by the&#xD;
      anesthetist not involved in the study. It will be labelled as study drug and will be&#xD;
      delivered by the investigator.&#xD;
&#xD;
      Group A will receive Inj Ketamine 0.30mg/kg bolus dose. Group B will receive Inj Fentanyl&#xD;
      1.5mcg/kg bolus dose. The drug will be prepared in an identical sterile syringe as a clear&#xD;
      fluid and will be labelled as &quot;study drug&quot;.&#xD;
&#xD;
      Patient will receive the study drug according to randomization.Then, 10 minutes after&#xD;
      delivery of the study drug, the patients will be kept in sitting position with the help of&#xD;
      operation theatre assistant while maintaining the skeletal traction. Numeric Rating Scale&#xD;
      will be enquired and noted. If the patient will report Numeric Rating Scale of 5 or more&#xD;
      during placement in the sitting position, procedure will be stopped and fentanyl 20 microgram&#xD;
      will given intravenously in the form of rescue analgesia before attempting to reposition&#xD;
      again. Once the patient will be in sitting position subarachnoid will be performed in L 3-4&#xD;
      inter space using 2.4ml of 0.5% hyperbaric bupivacaine maintaining strict asepsis. The&#xD;
      patient will be laid down back to supine position. The level of sensory block and motor block&#xD;
      will assessed. After ascertaining adequate block, patient will be shifted to fracture table&#xD;
      for operation. The number attempts required for successful subarachnoid block will be noted.&#xD;
      The quality of patient positioning will subjectively be rated as good, satisfactory and&#xD;
      optimal depending upon the ease of positioning for subarachnoid block by the anesthetist.&#xD;
      Sedation scoring will be noted for 30 minutes after delivery of the study drug. All the vital&#xD;
      parameters will be monitored continuously and recorded every 3 minutes for first 15 minutes&#xD;
      then every 10 minutes throughout the surgery and once in Post Anesthesia Care Unit. Patient&#xD;
      will be assessed for the presence any adverse effect of the study drug throughout the&#xD;
      surgery. The level of satisfaction regarding the analgesia during positioning will be&#xD;
      questioned to the patient using Likert Scale in PACU. The time required for the patients to&#xD;
      be discharged from PACU will be noted.&#xD;
&#xD;
      Data management Data handling- Data will be entered in Microsoft Excel 2016 and converted&#xD;
      into Statistical package for social sciences (SPSS 11.5) for statistical analysis&#xD;
      Coding-Alpha numerical code will be used Monitoring-Data will be entered after every day of&#xD;
      work. Data will be reported to guide and co-guides every week.&#xD;
&#xD;
      Statistical Methods Collected data will be entered in Microsoft Excel 2010 and be converted&#xD;
      into SPSS software 11.5 version for statistical analysis.&#xD;
&#xD;
      For descriptive statistics percentage, mean, Standard deviation, median, interquartile range&#xD;
      will be calculated along with graphical and tabular presentation. For inferential statistics&#xD;
      Chi square test, independent t test, Mann Whitney U test will be applied to find out the&#xD;
      significant difference between Fentanyl and Ketamine with selected clinical and demographic&#xD;
      parameter at 95% confidence interval where level of significance is considered p &lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 31, 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>
    <intervention_model_description>Ketamine Group: Ketamine 0.3mg/kg intavenously before changing the position from supine to sitting for subarachnoid block.&#xD;
Fentanyl group: Fentanyl 1.5mcg/kg intravenously before changing the position from supine to sitting position for subarachnoid block.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>0.4ml from one 1 ml ampule of 50mg ketamine will be diluted with 9.6ml NS to make a concentration of 2mg Ketamine in each ml in a 10 ml syringe.&#xD;
One 2ml ampule of 100mcg Fentanyl will be diluted with 8 ml NS to make a concentration of 10mcg in each ml in a 10ml syringe&#xD;
Ketamine and Fentanyl will be administered as clear fluid from a 10ml syringe labelled as Study drug, therefore, both the patient and investigator will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric Rating Scale for Pain</measure>
    <time_frame>1 to 20 minutes</time_frame>
    <description>Level of analgesia for subarachnoid block in sitting position measured by Numeric Rating Rating Scale for pain. Scale ranges from 0 to 10, where 0 is no pain and 10 being maximum/ worst imaginable pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Likert Satisfaction score</measure>
    <time_frame>1 to 20 minutes</time_frame>
    <description>Patient satisfaction for positioning the patient for subarachnoid block using Likert score will be used. It ranges from 1 to 5 (1=strongly dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=strongly satisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anesthetist Satisfaction Score</measure>
    <time_frame>1 to 20 minutes</time_frame>
    <description>Anesthetist satisfaction for positioning the patient for subarachnoid block as good, satisfactory and Optimal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of attempts for successful spinal needle placement</measure>
    <time_frame>1 to 20 minutes (While performing subarachnoid block)</time_frame>
    <description>Number of attempts for successful spinal needle placement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects</measure>
    <time_frame>1 to 120 minutes (Intraoperatively)</time_frame>
    <description>Occurrence of any adverse events like hypotension, bradycardia, hallucination, nausea and vomiting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Wilson Sedation Scale</measure>
    <time_frame>1 to 120 minutes (Intraoperatively)</time_frame>
    <description>Sedation score of the patients will be noted (1=Oriented, 2=Drowsy,3=Arousable,4=Unarousable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Aldrerte Score</measure>
    <time_frame>10 to 30 minutes (In post anesthesia care unit)</time_frame>
    <description>Time required by patients of each group to be discharged from the PACU will be noted bu using Modified Aldrerte Score (Score of 9-10=can be discharged, 8 or less=close monitoring needed)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Fracture of Proximal End of Femur</condition>
  <arm_group>
    <arm_group_label>Ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will be given Ketamine 0.3mg/kg intravenously before sitting positioning for subarachnoid block.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fentanyl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will be given Fentanyl 1.5mcg/kg intravenously before sitting position for subarachnoid block.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>in this group, patient will receive ketamine at 0.3mg/kg intravenously.</description>
    <arm_group_label>Ketamine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>In this group, the patients will receive fentanyl at 1.5mcg/kg intavenously.</description>
    <arm_group_label>Fentanyl</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Inclusion criteria:&#xD;
&#xD;
             Patients undergoing Subarachnoid block for proximal fracture femur&#xD;
&#xD;
               1. Age: above 18 years&#xD;
&#xD;
               2. ASA PS I, II&#xD;
&#xD;
          2. Exclusion criteria:&#xD;
&#xD;
               1. Refusal to participate in the study&#xD;
&#xD;
               2. Other painful co- morbidities&#xD;
&#xD;
               3. Allergy or any contraindication to study medication&#xD;
&#xD;
               4. Any contraindication to subarachnoid block&#xD;
&#xD;
               5. Analgesics 8 hours prior to performing sunarachnoid block&#xD;
&#xD;
               6. Pathologic fractures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bishnu Pokharel, MS</last_name>
    <role>Study Chair</role>
    <affiliation>B P Koirala Institute of Health and Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jenny Bajracharya, MD</last_name>
    <phone>9841455882</phone>
    <phone_ext>+977</phone_ext>
    <email>bajracharya.jenny@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Krishna Pokharel, MD</last_name>
    <phone>9841986321</phone>
    <phone_ext>+977</phone_ext>
    <email>drkrishnapokharel@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>B P Koirala Institute of Health and Sciences</name>
      <address>
        <city>Dharān Bāzār</city>
        <state>Sunsari</state>
        <zip>56700</zip>
        <country>Nepal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jenny Bajracharya, MBBS, MD</last_name>
      <phone>9841455882</phone>
      <phone_ext>+977</phone_ext>
      <email>bajracharya.jenny@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Krishna Pokharel, MBBS, MD</last_name>
      <phone>0941986321</phone>
      <phone_ext>+977</phone_ext>
      <email>drkrishnapokharel@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Jenny Bajracharya, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Krishna Pokharel, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Birendra Prasad Sah, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sindhu Khatiwada, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Asish Subedi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>B P Koirala Institute of Health and sciences</name>
      <address>
        <city>Dharān Bāzār</city>
        <state>Sunsari</state>
        <country>Nepal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jenny Bajracharya, MD</last_name>
      <phone>9841455882</phone>
      <phone_ext>+977</phone_ext>
      <email>bajracharya.jenny@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Nepal</country>
  </location_countries>
  <reference>
    <citation>Diakomi M, Papaioannou M, Mela A, Kouskouni E, Makris A. Preoperative fascia iliaca compartment block for positioning patients with hip fractures for central nervous blockade: a randomized trial. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):394-8. doi: 10.1097/AAP.0000000000000133.</citation>
    <PMID>25068412</PMID>
  </reference>
  <reference>
    <citation>Sia S, Pelusio F, Barbagli R, Rivituso C. Analgesia before performing a spinal block in the sitting position in patients with femoral shaft fracture: a comparison between femoral nerve block and intravenous fentanyl. Anesth Analg. 2004 Oct;99(4):1221-1224. doi: 10.1213/01.ANE.0000134812.00471.44.</citation>
    <PMID>15385380</PMID>
  </reference>
  <reference>
    <citation>The safety, benefits and effectiveness of different intravenous subanesthetic doses of ketamine when combined with small dose of midazolam before combined spinal epidural technique for Orthopedic Lower Extremity Surgery Moataz Moataz Morad El-Tawil Anesthesia Department, Faculty of Medicine, Menoufya University Abstract</citation>
  </reference>
  <reference>
    <citation>Aral A Mohammed, MD*, Mayada M Ali, MD.Ketamine analgesia before spinal anesthesia for fractured femur. Sudan Med J 2015;April;51(1)</citation>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>April 3, 2021</last_update_submitted>
  <last_update_submitted_qc>April 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>B.P. Koirala Institute of Health Sciences</investigator_affiliation>
    <investigator_full_name>Jenny Bajracharya</investigator_full_name>
    <investigator_title>Department of Anesthesia, Principal Investigator, Junior resident</investigator_title>
  </responsible_party>
  <keyword>Spinal anesthesia</keyword>
  <keyword>Ketamine</keyword>
  <keyword>Fentanyl</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Ketamine</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/NCT04418674
org study id: IRC/1597/019
nct id: NCT04418674
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a prospective comparative study which will be conducted in patients with proximal
      femur fracture undergoing operative interventions under subarachnoid block in sitting
      position. Ketamine group will receive 0.3mg/kg intravenously and Fentanyl group will receive
      1.5mcg/kg before changing the position from supine to sitting for subarachnoid block.
      Analgesic effectiveness of the two drugs will be compared by Numeric Rating Scale for pain.

      Research hypothesis (Null hypothesis) There is no difference in analgesic effectiveness,
      patient satisfaction, spinal performance and occurrence of adverse effects between
      Intravenous ketamine and intravenous fentanyl in patients with proximal femur fracture.

      Alternate hypothesis Intravenous Ketamine in patients with proximal femur fracture improves
      the level of analgesia, patient satisfaction, spinal performance and occurrence of adverse
      effects when compared to intravenous fentanyl.
Femur fracture is a common orthopedic problem following trauma in patients of all ages. It is
      a painful bone injury and is associated with severe pain and distress during preoperative
      period. Surgical repair is most commonly done in subarachnoid block. However, moving the
      patient for optimal positioning for spinal needle placement in subarachnoid space leads to
      severe pain. Adequate analgesia not only improves patient's comfort but has also been shown
      to improve positioning for subarachnoid block. Several analgesic modalities have been used to
      decrease movement evoked pain in these patients including the use of intravenous analgesics
      and blocks. However, there are only few studies comparing intravenous analgesics that
      alleviated the pain that occurs when changing position for subarachnoid block.

      Patient enrollment will be done by the primary investigator one day prior to the surgery. All
      eligible patients with American Society of Anesthesiologist Physical Status I, II fulfilling
      the inclusion criteria will be informed about the study and written consent will be obtained
      in pre operative visit, one day prior to the surgery, in the orthopedic in-patient ward.

      All patients will be kept nil per oral for 6 hours for solid, heavy meal, 4 hours for light
      meal and 2 hours for clear liquid. All the patients will be pre-medicated with Tab Lorazepam
      1mg (<50kg) and 2mg (>50kg) orally the night before and in the morning of the surgery.

      On the day of surgery, randomization will be done in pre operative holding area and the
      patient will be transferred to the operation theatre in trolley maintaining the skeletal
      traction. All standard monitoring devices like electrocardiogram, non-invasive blood pressure
      monitoring and pulse oximeter will be attached. Standard anesthesia monitoring including
      3-lead electrocardiography, oxygen saturation(Spo2), blood pressure(BP) and heart rate(HR)
      will be done.Baseline Numeric Rating Scale(NRS) for pain at rest and movement will be
      assessed (movement is defined at 5 cm active vertical movement of the limb).

      An intravenous line will be secured with 18 gauge intavenous cannula in the dorsum of hand.
      Pre-hydration will be started with Ringer's Lactate solution at 5ml/kg/hour.

      Dose of the drug required according to the body weight will be calculated and prepared by the
      anesthetist not involved in the study. It will be labelled as study drug and will be
      delivered by the investigator.

      Group A will receive Inj Ketamine 0.30mg/kg bolus dose. Group B will receive Inj Fentanyl
      1.5mcg/kg bolus dose. The drug will be prepared in an identical sterile syringe as a clear
      fluid and will be labelled as "study drug".

      Patient will receive the study drug according to randomization.Then, 10 minutes after
      delivery of the study drug, the patients will be kept in sitting position with the help of
      operation theatre assistant while maintaining the skeletal traction. Numeric Rating Scale
      will be enquired and noted. If the patient will report Numeric Rating Scale of 5 or more
      during placement in the sitting position, procedure will be stopped and fentanyl 20 microgram
      will given intravenously in the form of rescue analgesia before attempting to reposition
      again. Once the patient will be in sitting position subarachnoid will be performed in L 3-4
      inter space using 2.4ml of 0.5% hyperbaric bupivacaine maintaining strict asepsis. The
      patient will be laid down back to supine position. The level of sensory block and motor block
      will assessed. After ascertaining adequate block, patient will be shifted to fracture table
      for operation. The number attempts required for successful subarachnoid block will be noted.
      The quality of patient positioning will subjectively be rated as good, satisfactory and
      optimal depending upon the ease of positioning for subarachnoid block by the anesthetist.
      Sedation scoring will be noted for 30 minutes after delivery of the study drug. All the vital
      parameters will be monitored continuously and recorded every 3 minutes for first 15 minutes
      then every 10 minutes throughout the surgery and once in Post Anesthesia Care Unit. Patient
      will be assessed for the presence any adverse effect of the study drug throughout the
      surgery. The level of satisfaction regarding the analgesia during positioning will be
      questioned to the patient using Likert Scale in PACU. The time required for the patients to
      be discharged from PACU will be noted.

      Data management Data handling- Data will be entered in Microsoft Excel 2016 and converted
      into Statistical package for social sciences (SPSS 11.5) for statistical analysis
      Coding-Alpha numerical code will be used Monitoring-Data will be entered after every day of
      work. Data will be reported to guide and co-guides every week.

      Statistical Methods Collected data will be entered in Microsoft Excel 2010 and be converted
      into SPSS software 11.5 version for statistical analysis.

      For descriptive statistics percentage, mean, Standard deviation, median, interquartile range
      will be calculated along with graphical and tabular presentation. For inferential statistics
      Chi square test, independent t test, Mann Whitney U test will be applied to find out the
      significant difference between Fentanyl and Ketamine with selected clinical and demographic
      parameter at 95% confidence interval where level of significance is considered p <0.05.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Ketamine Group: Ketamine 0.3mg/kg intavenously before changing the position from supine to sitting for subarachnoid block.
Fentanyl group: Fentanyl 1.5mcg/kg intravenously before changing the position from supine to sitting position for subarachnoid block.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: 0.4ml from one 1 ml ampule of 50mg ketamine will be diluted with 9.6ml NS to make a concentration of 2mg Ketamine in each ml in a 10 ml syringe.
One 2ml ampule of 100mcg Fentanyl will be diluted with 8 ml NS to make a concentration of 10mcg in each ml in a 10ml syringe
Ketamine and Fentanyl will be administered as clear fluid from a 10ml syringe labelled as Study drug, therefore, both the patient and investigator will be blinded.
measure: Numeric Rating Scale for Pain
time frame: 1 to 20 minutes
description: Level of analgesia for subarachnoid block in sitting position measured by Numeric Rating Rating Scale for pain. Scale ranges from 0 to 10, where 0 is no pain and 10 being maximum/ worst imaginable pain.
measure: Likert Satisfaction score
time frame: 1 to 20 minutes
description: Patient satisfaction for positioning the patient for subarachnoid block using Likert score will be used. It ranges from 1 to 5 (1=strongly dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=strongly satisfied)
measure: Anesthetist Satisfaction Score
time frame: 1 to 20 minutes
description: Anesthetist satisfaction for positioning the patient for subarachnoid block as good, satisfactory and Optimal
measure: Number of attempts for successful spinal needle placement
time frame: 1 to 20 minutes (While performing subarachnoid block)
description: Number of attempts for successful spinal needle placement
measure: Adverse effects
time frame: 1 to 120 minutes (Intraoperatively)
description: Occurrence of any adverse events like hypotension, bradycardia, hallucination, nausea and vomiting.
measure: Modified Wilson Sedation Scale
time frame: 1 to 120 minutes (Intraoperatively)
description: Sedation score of the patients will be noted (1=Oriented, 2=Drowsy,3=Arousable,4=Unarousable)
measure: Modified Aldrerte Score
time frame: 10 to 30 minutes (In post anesthesia care unit)
description: Time required by patients of each group to be discharged from the PACU will be noted bu using Modified Aldrerte Score (Score of 9-10=can be discharged, 8 or less=close monitoring needed)
arm group label: Ketamine
arm group type: Experimental
description: Patient will be given Ketamine 0.3mg/kg intravenously before sitting positioning for subarachnoid block.
arm group label: Fentanyl
arm group type: Active Comparator
description: Patient will be given Fentanyl 1.5mcg/kg intravenously before sitting position for subarachnoid block.
intervention type: Drug
intervention name: Ketamine
description: in this group, patient will receive ketamine at 0.3mg/kg intravenously.
arm group label: Ketamine
intervention type: Drug
intervention name: Fentanyl
description: In this group, the patients will receive fentanyl at 1.5mcg/kg intavenously.
arm group label: Fentanyl
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bishnu Pokharel, MS
role: Study Chair
affiliation: B P Koirala Institute of Health and Sciences
last name: Jenny Bajracharya, MD
phone: 9841455882
phone ext: +977
email: bajracharya.jenny@gmail.com
last name: Krishna Pokharel, MD
phone: 9841986321
phone ext: +977
email: drkrishnapokharel@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Nepal
citation: Diakomi M, Papaioannou M, Mela A, Kouskouni E, Makris A. Preoperative fascia iliaca compartment block for positioning patients with hip fractures for central nervous blockade: a randomized trial. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):394-8. doi: 10.1097/AAP.0000000000000133.
PMID: 25068412
citation: Sia S, Pelusio F, Barbagli R, Rivituso C. Analgesia before performing a spinal block in the sitting position in patients with femoral shaft fracture: a comparison between femoral nerve block and intravenous fentanyl. Anesth Analg. 2004 Oct;99(4):1221-1224. doi: 10.1213/01.ANE.0000134812.00471.44.
PMID: 15385380
citation: The safety, benefits and effectiveness of different intravenous subanesthetic doses of ketamine when combined with small dose of midazolam before combined spinal epidural technique for Orthopedic Lower Extremity Surgery Moataz Moataz Morad El-Tawil Anesthesia Department, Faculty of Medicine, Menoufya University Abstract
citation: Aral A Mohammed, MD*, Mayada M Ali, MD.Ketamine analgesia before spinal anesthesia for fractured femur. Sudan Med J 2015;April;51(1)
responsible party type: Sponsor-Investigator
investigator affiliation: B.P. Koirala Institute of Health Sciences
investigator full name: Jenny Bajracharya
investigator title: Department of Anesthesia, Principal Investigator, Junior resident
mesh term: Fractures, Bone
mesh term: Femoral Fractures
mesh term: Fentanyl
mesh term: Ketamine
sharing ipd: No