<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/NCT03781505</url>
  </required_header>
  <id_info>
    <org_study_id>5445-Ane-ERC-18</org_study_id>
    <nct_id>NCT03781505</nct_id>
  </id_info>
  <brief_title>Effect of Intravenous Paracetamol in Combination With Caudal Ropivacaine on Quality of Postoperative Recovery in Paediatric Patients Undergoing Hypospadias Repair</brief_title>
  <official_title>Effect of Intravenous Paracetamol in Combination With Caudal Ropivacaine on Quality of Postoperative Recovery in Paediatric Patients Undergoing Hypospadias Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aga Khan 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate whether the addition of intravenous paracetamol with caudal ropivacaine leads&#xD;
      to better quality of postoperative recovery in patients undergoing hypospadius repair than&#xD;
      caudal ropivacaine alone. The quality of recovery will be judged by postoperative analgesia&#xD;
      requirement and lesser agitation in the postoperative period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After obtaining approval from Ethical Review Committee (ERC) of Aga Khan University Hospital&#xD;
      Karachi (AKUH) and inform about the study to primary surgeon (who ever doing the surgical&#xD;
      procedure on this time), informed written consent will be obtained from the parents of&#xD;
      patients fulfilling the inclusion criteria schedule for surgical procedures on the day before&#xD;
      surgery. Assent will be obtained from older children.&#xD;
&#xD;
      The patients will be assigned to one of the two groups by randomization through sealed opaque&#xD;
      envelope technique. The envelopes will be prepared using a computer generated randomization&#xD;
      table. Randomization envelopes will be used in consecutive order.&#xD;
&#xD;
      Patients will be allocated to either placebo group, who will not receive intravenous&#xD;
      paracetamol, or group who will receive intravenous paracetamol.&#xD;
&#xD;
      All patient will be given general anesthesia as per standard of care. Anaesthesia will be&#xD;
      standardized as follow. Anaesthesia will be induced by the inhalational route with&#xD;
      application of facemask with 8% sevoflurane in 50% oxygen-nitrous oxide mixture. Airway will&#xD;
      be managed by laryngeal mask airway (LMA) of appropriate size as recommended by manufacturer&#xD;
      and anesthesia will be subsequently maintained with Minimum alveolar concentration 1-2%&#xD;
      sevoflurane in 40% oxygen-nitrous mixture with spontaneous ventilation via LMA. Heart rate&#xD;
      (HR), noninvasive blood pressure, core body temperature (oral/nasal probe), end-tidal carbon&#xD;
      dioxide (ETCO2) and oxygen saturation by pulse oximetry (SpO2) will be monitored throughout.&#xD;
&#xD;
      After induction of anaesthesia, patients will be turned to lateral position and maximum safe&#xD;
      dose of ropivacaine will be calculated (3mg/kg) and documented. After all aseptic measures,&#xD;
      butterfly needle (size 23 gauge) will be inserted into the sacral hiatus. A total volume of 1&#xD;
      ml/kg of 0.25% ropivacaine solution will be injected in caudal space. The time of performing&#xD;
      block will be noted. The success of caudal analgesia will be assessed by monitoring the&#xD;
      parameters like heart rate (HR) and blood pressure (BP) in response to incision. In case of&#xD;
      tachycardia (&gt;20% from baseline) and hypertension (&gt;20% from baseline), the concentration of&#xD;
      sevoflurane will be adjusted. If tachycardia persists for more than 5 minutes despite&#xD;
      increasing the sevoflurane concentration, rescue analgesia in the form of fentanyl 1mcg/kg&#xD;
      will be administered.&#xD;
&#xD;
      Study drugs will be prepared and dispatch by Clinical Trial Unit (CTU) pharmacy. Eligible&#xD;
      consecutive randomized patients belonging to study group will receive intravenous paracetamol&#xD;
      approximately about an hour before the end of surgery with a dose of 15mg/kg over 15 to 20&#xD;
      minutes. While the patients belonging to other group will receive placebo. Time of&#xD;
      intravenous paracetamol administration will be noted.&#xD;
&#xD;
      After emergence, the children will be taken to the postanesthesia care unit (PACU) where&#xD;
      parents will be called to stay with their child. Time of arrival in the recovery room will be&#xD;
      noted.The Mean arterial pressures (MAP), heart rate HR, oxygen saturation by pulse oximetry&#xD;
      (SPO2), respiratory rate (RR), sedation, agitation, quality and duration of analgesia will be&#xD;
      recorded at 15 and 30 minutes and will be followed by 1, 2, 4, and 6 hours following recovery&#xD;
      from anaesthesia.&#xD;
&#xD;
      The analgesic status of the patient will be evaluated by trained Research Assistant in the&#xD;
      PACU and in the ward by using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS).&#xD;
      This includes crying, facial expression, verbal response, touching the wound and torso and&#xD;
      leg movement. It is given in the Appendix.&#xD;
&#xD;
      Sedation will be assessed using a five point scale (0: awake; 1: mild sedation; 2: sleeping,&#xD;
      but able to wake; 3: in deep sleep, unable to wake). These observations will be recorded by&#xD;
      the same investigator blinded to the medication administered. Same observer will perform the&#xD;
      measurements for all patients. A pain score lower than 4 will be considered adequate&#xD;
      analgesia. Rescue analgesia will be provided by 0.1 mg/kg i.v. morphine in divided doses&#xD;
      (0.025 mg aliquots) and time of doses will be noted on the form.&#xD;
&#xD;
      Analgesia requirement in the postoperative period will be define as a CHEOPS score of 7 or&#xD;
      more. Time to the first analgesic requirement will be calculated as the time from the&#xD;
      performance of caudal block to the first analgesic dose administered.&#xD;
&#xD;
      Complications like motor block, hypotension and urinary retention will be monitored and&#xD;
      recorded in the postoperative period. Modified Bromage Scale will be used to assess motor&#xD;
      block i.e 0= No block, 1= Able to move legs, 2= Unable to move legs.&#xD;
&#xD;
      Adverse effects:&#xD;
&#xD;
      Adverse Events are defined as 'Any untoward medical occurrence in a trial patient to whom a&#xD;
      research treatment or procedure has been administered, including occurrences which are not&#xD;
      necessarily caused by or related to that treatment or procedure.&#xD;
&#xD;
      Adverse effects associated with the paracetamol are rare &lt;1/10000, which includes malaise,&#xD;
      increased level of hepatic transaminases and hypersensitivity reaction.&#xD;
&#xD;
      The following data will be collected by an observer in postoperative period: age, weight,&#xD;
      height, surgical time, anesthesia time, recovery time, discharge time, need to increase&#xD;
      sevoflurane concentration after incision, the need for rescue analgesia in operating room&#xD;
      (OR) and PACU, time of voiding urine and time of taking oral fluids, while subjective&#xD;
      complaint of heaviness in legs will be asked from children above 3 years only.&#xD;
&#xD;
      SAMPLE SELECTION Inclusion criteria&#xD;
&#xD;
        1. Age 3-10 years&#xD;
&#xD;
        2. American Society of Anesthesiologist class I and II&#xD;
&#xD;
        3. Undergoing hypospadias repair surgery&#xD;
&#xD;
      Exclusion criteria&#xD;
&#xD;
        1. Coagulopathy&#xD;
&#xD;
        2. Aspirin or any other analgesic ingestion in the preceding week&#xD;
&#xD;
        3. Preexisting neurological or spinal disease&#xD;
&#xD;
        4. Hepatic, renal disease and malnutrition&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Anticipated">August 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2022</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>
    <intervention_model_description>Randomized control trail</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative analgesia requirement</measure>
    <time_frame>follow till 6 hours postoperatively</time_frame>
    <description>Time to the first analgesic requirement will be calculated as the time from the performance of caudal block to the first analgesic dose administered. This time will be noted in minutes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) Assessement for Postoperative Pain</measure>
    <time_frame>follow till 6 hours postoperatively</time_frame>
    <description>The requirement of postoperative analgesia of the patient will be evaluated by using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS). This scale has 5 domains. It includes crying, facial expression, verbal response, touching the wound and torso and leg movement. It is a behavioural scale and measures each domain on a numerical scale of 0 to 2. Minimum score is 0 while maximum score is 10. Aggregate score will be added. Score less than 4 will be consider adequate analgesia while score greater than 4 will be consider inadequate analgesia. This score is just a numerical number with no other value attached to it.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sedation</measure>
    <time_frame>follow till 6 hours postoperatively</time_frame>
    <description>Sedation will be assessed by using Pasero Opioid-Induced Sedation Scale (POSS). This scale measures sedation on numerical score of 0 to 4. Minimum score is 0 while maximum score is 4.&#xD;
It comprises of; 0: awake; 1: mild sedation; 2: sleeping, but able to wake; 3: Frequently drowsy, arousable, drifts off to sleep during conversation, unable to wake and 4: Somnolent, minimal or no response to verbal or physical stimulation.&#xD;
A POSS score of 0, 1, or 2 indicates an acceptable level of sedation, whereas a score of 3 or 4 indicates over-sedation and the need for a reversal agent. This score is just a numerical number with no other value attached to it.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Postoperative Analgesia</condition>
  <arm_group>
    <arm_group_label>Intravenous paracetamol with Caudal Ropivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paracetamol is widely accepted and most commonly used as an adjuvant for postoperative analgesia. It also improves the quality of recovery by attenuating the pain associated with the surgical position. Adverse effects associated with the paracetamol are rare &lt;1/10000, which includes malaise, increased level of hepatic transaminases and hypersensitivity reaction. It has been studied in combination with caudal analgesia with bupivacaine through the rectal route 7,8 with variable results.&#xD;
Caudal anaesthesia is effective in alleviating pain below the umbilicus. Also if the caudal block is administered at the beginning of surgery, the effect will start wearing off 2 to 3 hours post surgery. Administration of paracetamol towards end of surgery may help with both these issues. In this study we aim to investigate the effect of adding intravenous paracetamol in combination with caudal analgesia with ropivacaine, hoping that it may improve quality of postoperative analgesia and recovery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intravenous Normal Saline with Caudal Ropivacaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol +caudal ropivacaine</intervention_name>
    <description>Paracetamol + Ropivacaine</description>
    <arm_group_label>Intravenous paracetamol with Caudal Ropivacaine</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 3-10 years&#xD;
&#xD;
          2. ASA I and II&#xD;
&#xD;
          3. Undergoing hypospadias repair surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Coagulopathy&#xD;
&#xD;
          2. Aspirin or any other analgesic ingestion in the preceding week&#xD;
&#xD;
          3. Preexisting neurological or spinal disease&#xD;
&#xD;
          4. Hepatic, renal disease and malnutrition&#xD;
&#xD;
          5. Severe hypovolemia&#xD;
&#xD;
          6. Uncontrolled convulsions&#xD;
&#xD;
          7. Refusal of the parents&#xD;
&#xD;
          8. Local Skin infection at the puncture site&#xD;
&#xD;
          9. Allergy to local anesthetics&#xD;
&#xD;
         10. Patient previously involved in other studies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Muhammad S Yousuf, FCPS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aga Khan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Muhammad S Yousuf, FCPS</last_name>
    <phone>9221+3003540362</phone>
    <phone_ext>4637</phone_ext>
    <email>saad.yousuf@aku.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fauzia A Khan, FRCA</last_name>
    <email>fauzia.khan@aku.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Aga Khan University Hospital</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <zip>74800</zip>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Muhammad S Yousuf, FCPS</last_name>
      <phone>00923003540362</phone>
      <email>saad.yousuf@aku.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>Miller RD. Anesthesia. 7th ed. [United States]: Elsevier Science Health Science div; 2010</citation>
  </reference>
  <reference>
    <citation>Samuel M, Hampson-Evans D, Cunnington P. Prospective to a randomized double-blind controlled trial to assess efficacy of double caudal analgesia in hypospadias repair. J Pediatr Surg. 2002 Feb;37(2):168-74. doi: 10.1053/jpsu.2002.30247.</citation>
    <PMID>11819193</PMID>
  </reference>
  <reference>
    <citation>Gauntlett I. A comparison between local anaesthetic dorsal nerve block and caudal bupivacaine with ketamine for paediatric circumcision. Paediatr Anaesth. 2003 Jan;13(1):38-42. doi: 10.1046/j.1460-9592.2003.00926.x.</citation>
    <PMID>12535037</PMID>
  </reference>
  <reference>
    <citation>Sharpe P, Klein JR, Thompson JP, Rushman SC, Sherwin J, Wandless JG, Fell D. Analgesia for circumcision in a paediatric population: comparison of caudal bupivacaine alone with bupivacaine plus two doses of clonidine. Paediatr Anaesth. 2001 Nov;11(6):695-700. doi: 10.1046/j.1460-9592.2001.00748.x.</citation>
    <PMID>11696146</PMID>
  </reference>
  <reference>
    <citation>Lee HM, Sanders GM. Caudal ropivacaine and ketamine for postoperative analgesia in children. Anaesthesia. 2000 Aug;55(8):806-10. doi: 10.1046/j.1365-2044.2000.01330-2.x.</citation>
    <PMID>10947698</PMID>
  </reference>
  <reference>
    <citation>Turan A, Memis D, Basaran UN, Karamanlioglu B, Sut N. Caudal ropivacaine and neostigmine in pediatric surgery. Anesthesiology. 2003 Mar;98(3):719-22. doi: 10.1097/00000542-200303000-00021.</citation>
    <PMID>12606917</PMID>
  </reference>
  <reference>
    <citation>Mercan A, Sayin MM, Saydam S, Ozmert S, Tiryaki T. When to add supplemental rectal paracetamol for postoperative analgesia with caudal bupivacaine in children? A prospective, double-blind, randomized study. Paediatr Anaesth. 2007 Jun;17(6):547-51. doi: 10.1111/j.1460-9592.2006.02141.x.</citation>
    <PMID>17498016</PMID>
  </reference>
  <reference>
    <citation>Ozyuvaci E, Altan A, Yucel M, Yenmez K. Evaluation of adding preoperative or postoperative rectal paracetamol to caudal bupivacaine for postoperative analgesia in children. Paediatr Anaesth. 2004 Aug;14(8):661-5. doi: 10.1111/j.1460-9592.2004.01255.x.</citation>
    <PMID>15283825</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Dr. Muhammad Saad Yousuf</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypospadias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 4, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03781505
org study id: 5445-Ane-ERC-18
nct id: NCT03781505
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To investigate whether the addition of intravenous paracetamol with caudal ropivacaine leads
      to better quality of postoperative recovery in patients undergoing hypospadius repair than
      caudal ropivacaine alone. The quality of recovery will be judged by postoperative analgesia
      requirement and lesser agitation in the postoperative period.
After obtaining approval from Ethical Review Committee (ERC) of Aga Khan University Hospital
      Karachi (AKUH) and inform about the study to primary surgeon (who ever doing the surgical
      procedure on this time), informed written consent will be obtained from the parents of
      patients fulfilling the inclusion criteria schedule for surgical procedures on the day before
      surgery. Assent will be obtained from older children.

      The patients will be assigned to one of the two groups by randomization through sealed opaque
      envelope technique. The envelopes will be prepared using a computer generated randomization
      table. Randomization envelopes will be used in consecutive order.

      Patients will be allocated to either placebo group, who will not receive intravenous
      paracetamol, or group who will receive intravenous paracetamol.

      All patient will be given general anesthesia as per standard of care. Anaesthesia will be
      standardized as follow. Anaesthesia will be induced by the inhalational route with
      application of facemask with 8% sevoflurane in 50% oxygen-nitrous oxide mixture. Airway will
      be managed by laryngeal mask airway (LMA) of appropriate size as recommended by manufacturer
      and anesthesia will be subsequently maintained with Minimum alveolar concentration 1-2%
      sevoflurane in 40% oxygen-nitrous mixture with spontaneous ventilation via LMA. Heart rate
      (HR), noninvasive blood pressure, core body temperature (oral/nasal probe), end-tidal carbon
      dioxide (ETCO2) and oxygen saturation by pulse oximetry (SpO2) will be monitored throughout.

      After induction of anaesthesia, patients will be turned to lateral position and maximum safe
      dose of ropivacaine will be calculated (3mg/kg) and documented. After all aseptic measures,
      butterfly needle (size 23 gauge) will be inserted into the sacral hiatus. A total volume of 1
      ml/kg of 0.25% ropivacaine solution will be injected in caudal space. The time of performing
      block will be noted. The success of caudal analgesia will be assessed by monitoring the
      parameters like heart rate (HR) and blood pressure (BP) in response to incision. In case of
      tachycardia (>20% from baseline) and hypertension (>20% from baseline), the concentration of
      sevoflurane will be adjusted. If tachycardia persists for more than 5 minutes despite
      increasing the sevoflurane concentration, rescue analgesia in the form of fentanyl 1mcg/kg
      will be administered.

      Study drugs will be prepared and dispatch by Clinical Trial Unit (CTU) pharmacy. Eligible
      consecutive randomized patients belonging to study group will receive intravenous paracetamol
      approximately about an hour before the end of surgery with a dose of 15mg/kg over 15 to 20
      minutes. While the patients belonging to other group will receive placebo. Time of
      intravenous paracetamol administration will be noted.

      After emergence, the children will be taken to the postanesthesia care unit (PACU) where
      parents will be called to stay with their child. Time of arrival in the recovery room will be
      noted.The Mean arterial pressures (MAP), heart rate HR, oxygen saturation by pulse oximetry
      (SPO2), respiratory rate (RR), sedation, agitation, quality and duration of analgesia will be
      recorded at 15 and 30 minutes and will be followed by 1, 2, 4, and 6 hours following recovery
      from anaesthesia.

      The analgesic status of the patient will be evaluated by trained Research Assistant in the
      PACU and in the ward by using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS).
      This includes crying, facial expression, verbal response, touching the wound and torso and
      leg movement. It is given in the Appendix.

      Sedation will be assessed using a five point scale (0: awake; 1: mild sedation; 2: sleeping,
      but able to wake; 3: in deep sleep, unable to wake). These observations will be recorded by
      the same investigator blinded to the medication administered. Same observer will perform the
      measurements for all patients. A pain score lower than 4 will be considered adequate
      analgesia. Rescue analgesia will be provided by 0.1 mg/kg i.v. morphine in divided doses
      (0.025 mg aliquots) and time of doses will be noted on the form.

      Analgesia requirement in the postoperative period will be define as a CHEOPS score of 7 or
      more. Time to the first analgesic requirement will be calculated as the time from the
      performance of caudal block to the first analgesic dose administered.

      Complications like motor block, hypotension and urinary retention will be monitored and
      recorded in the postoperative period. Modified Bromage Scale will be used to assess motor
      block i.e 0= No block, 1= Able to move legs, 2= Unable to move legs.

      Adverse effects:

      Adverse Events are defined as 'Any untoward medical occurrence in a trial patient to whom a
      research treatment or procedure has been administered, including occurrences which are not
      necessarily caused by or related to that treatment or procedure.

      Adverse effects associated with the paracetamol are rare <1/10000, which includes malaise,
      increased level of hepatic transaminases and hypersensitivity reaction.

      The following data will be collected by an observer in postoperative period: age, weight,
      height, surgical time, anesthesia time, recovery time, discharge time, need to increase
      sevoflurane concentration after incision, the need for rescue analgesia in operating room
      (OR) and PACU, time of voiding urine and time of taking oral fluids, while subjective
      complaint of heaviness in legs will be asked from children above 3 years only.

      SAMPLE SELECTION Inclusion criteria

        1. Age 3-10 years

        2. American Society of Anesthesiologist class I and II

        3. Undergoing hypospadias repair surgery

      Exclusion criteria

        1. Coagulopathy

        2. Aspirin or any other analgesic ingestion in the preceding week

        3. Preexisting neurological or spinal disease

        4. Hepatic, renal disease and malnutrition
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized control trail
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Postoperative analgesia requirement
time frame: follow till 6 hours postoperatively
description: Time to the first analgesic requirement will be calculated as the time from the performance of caudal block to the first analgesic dose administered. This time will be noted in minutes.
measure: Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) Assessement for Postoperative Pain
time frame: follow till 6 hours postoperatively
description: The requirement of postoperative analgesia of the patient will be evaluated by using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS). This scale has 5 domains. It includes crying, facial expression, verbal response, touching the wound and torso and leg movement. It is a behavioural scale and measures each domain on a numerical scale of 0 to 2. Minimum score is 0 while maximum score is 10. Aggregate score will be added. Score less than 4 will be consider adequate analgesia while score greater than 4 will be consider inadequate analgesia. This score is just a numerical number with no other value attached to it.
measure: Sedation
time frame: follow till 6 hours postoperatively
description: Sedation will be assessed by using Pasero Opioid-Induced Sedation Scale (POSS). This scale measures sedation on numerical score of 0 to 4. Minimum score is 0 while maximum score is 4.
It comprises of; 0: awake; 1: mild sedation; 2: sleeping, but able to wake; 3: Frequently drowsy, arousable, drifts off to sleep during conversation, unable to wake and 4: Somnolent, minimal or no response to verbal or physical stimulation.
A POSS score of 0, 1, or 2 indicates an acceptable level of sedation, whereas a score of 3 or 4 indicates over-sedation and the need for a reversal agent. This score is just a numerical number with no other value attached to it.
arm group label: Intravenous paracetamol with Caudal Ropivacaine
arm group type: Experimental
description: Paracetamol is widely accepted and most commonly used as an adjuvant for postoperative analgesia. It also improves the quality of recovery by attenuating the pain associated with the surgical position. Adverse effects associated with the paracetamol are rare <1/10000, which includes malaise, increased level of hepatic transaminases and hypersensitivity reaction. It has been studied in combination with caudal analgesia with bupivacaine through the rectal route 7,8 with variable results.
Caudal anaesthesia is effective in alleviating pain below the umbilicus. Also if the caudal block is administered at the beginning of surgery, the effect will start wearing off 2 to 3 hours post surgery. Administration of paracetamol towards end of surgery may help with both these issues. In this study we aim to investigate the effect of adding intravenous paracetamol in combination with caudal analgesia with ropivacaine, hoping that it may improve quality of postoperative analgesia and recovery.
arm group label: Placebo
arm group type: Placebo Comparator
description: Intravenous Normal Saline with Caudal Ropivacaine
intervention type: Drug
intervention name: Paracetamol +caudal ropivacaine
description: Paracetamol + Ropivacaine
arm group label: Intravenous paracetamol with Caudal Ropivacaine
arm group label: Placebo
criteria: 
gender: All
minimum age: 3 Years
maximum age: 10 Years
healthy volunteers: No
last name: Muhammad S Yousuf, FCPS
role: Principal Investigator
affiliation: Aga Khan University
last name: Muhammad S Yousuf, FCPS
phone: 9221+3003540362
phone ext: 4637
email: saad.yousuf@aku.edu
last name: Fauzia A Khan, FRCA
email: fauzia.khan@aku.edu
facility: 
status: Recruiting
contact: 
country: Pakistan
citation: Miller RD. Anesthesia. 7th ed. [United States]: Elsevier Science Health Science div; 2010
citation: Samuel M, Hampson-Evans D, Cunnington P. Prospective to a randomized double-blind controlled trial to assess efficacy of double caudal analgesia in hypospadias repair. J Pediatr Surg. 2002 Feb;37(2):168-74. doi: 10.1053/jpsu.2002.30247.
PMID: 11819193
citation: Gauntlett I. A comparison between local anaesthetic dorsal nerve block and caudal bupivacaine with ketamine for paediatric circumcision. Paediatr Anaesth. 2003 Jan;13(1):38-42. doi: 10.1046/j.1460-9592.2003.00926.x.
PMID: 12535037
citation: Sharpe P, Klein JR, Thompson JP, Rushman SC, Sherwin J, Wandless JG, Fell D. Analgesia for circumcision in a paediatric population: comparison of caudal bupivacaine alone with bupivacaine plus two doses of clonidine. Paediatr Anaesth. 2001 Nov;11(6):695-700. doi: 10.1046/j.1460-9592.2001.00748.x.
PMID: 11696146
citation: Lee HM, Sanders GM. Caudal ropivacaine and ketamine for postoperative analgesia in children. Anaesthesia. 2000 Aug;55(8):806-10. doi: 10.1046/j.1365-2044.2000.01330-2.x.
PMID: 10947698
citation: Turan A, Memis D, Basaran UN, Karamanlioglu B, Sut N. Caudal ropivacaine and neostigmine in pediatric surgery. Anesthesiology. 2003 Mar;98(3):719-22. doi: 10.1097/00000542-200303000-00021.
PMID: 12606917
citation: Mercan A, Sayin MM, Saydam S, Ozmert S, Tiryaki T. When to add supplemental rectal paracetamol for postoperative analgesia with caudal bupivacaine in children? A prospective, double-blind, randomized study. Paediatr Anaesth. 2007 Jun;17(6):547-51. doi: 10.1111/j.1460-9592.2006.02141.x.
PMID: 17498016
citation: Ozyuvaci E, Altan A, Yucel M, Yenmez K. Evaluation of adding preoperative or postoperative rectal paracetamol to caudal bupivacaine for postoperative analgesia in children. Paediatr Anaesth. 2004 Aug;14(8):661-5. doi: 10.1111/j.1460-9592.2004.01255.x.
PMID: 15283825
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Dr. Muhammad Saad Yousuf
investigator title: Principal Investigator
mesh term: Hypospadias
mesh term: Acetaminophen
mesh term: Ropivacaine
sharing ipd: No
submitted: August 4, 2023