<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/NCT04479215</url>
  </required_header>
  <id_info>
    <org_study_id>2020-3509-11353</org_study_id>
    <nct_id>NCT04479215</nct_id>
  </id_info>
  <brief_title>Feeding Practices After the Surgery and Incidence of Vomiting</brief_title>
  <official_title>Postoperative Feeding Practice and Its Effect on Postoperative Vomiting in Children Undergoing Infra-umbilical Daycare Surgery: A Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University Hospital, Pakistan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aga Khan University Hospital, Pakistan</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>
      This study is aimed to only observe the feeding practices after surgery in children&#xD;
      undergoing below umbilicus surgery in day care and any impact of length of fasting on&#xD;
      vomiting after surgery. If the child meets the criteria for being included in this study, the&#xD;
      parents will be provided with informed consent form at the time of arrival at the daycare&#xD;
      unit or at the time of arrival in the waiting area of the operating room. If parents agree&#xD;
      and sign the consent form, then the child will be included in the study. The length of&#xD;
      fasting period after the surgery and any episode of vomiting from after surgery till&#xD;
      discharge time to home, will be recorded on a printed form. The nature of this study is only&#xD;
      observation and the child will not be subjected to any new technique or medications. Parents&#xD;
      will also be contacted on the next day of surgery on the phone number for any further&#xD;
      observation about the child's feeding and vomiting and parental satisfaction with the&#xD;
      anesthesia given will also be asked.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After approval from the departmental research committee and College of Physicians and&#xD;
      Surgeons Pakistan (CPSP), all pediatric patients fulfilling the inclusion criteria undergoing&#xD;
      elective outpatient infra-umbilical surgery under general anesthesia combined with caudal&#xD;
      analgesia at Aga Khan University Hospital would be enrolled for this study. Informed parental&#xD;
      consent will be taken after explaining the purpose and procedure of the study.&#xD;
&#xD;
      All patients will be assessed preoperatively for anesthesia fitness by history, physical&#xD;
      examination and laboratory investigations. On arrival on the day of surgery, patient will be&#xD;
      premedicated with midazolam 0.3mg/kg, 30-45 minutes before the procedure. The following&#xD;
      information including age, gender, weight, ASA status, time of last oral intake, preoperative&#xD;
      fasting duration, surgical procedure, any history of POV with prior surgery and history of&#xD;
      POV in parents or siblings will also be noted preoperatively. Patients at high risk of POV&#xD;
      will not be included in the study as prophylactic antiemetic is needed to be given to such&#xD;
      patients. Once the patient is taken into the operation room, standard ASA monitoring&#xD;
      including electrocardiography, non-invasive blood pressure and pulse oximetry will be&#xD;
      applied. Mode of induction will be inhalational with 8% sevoflurane and 100% oxygen or&#xD;
      intravenous with propofol 2.5-3mg/kg. Airway will be secured with a supraglottic device&#xD;
      appropriate to the weight of the patient. Patient will be positioned for caudal block which&#xD;
      will be performed using small gauge butterfly cannula using 0.25% ropivacaine in a dosage of&#xD;
      1ml/kg body weight with a maximum safe dose of 3mg/kg. Maintenance will be achieved with&#xD;
      isoflurane in an oxygen and nitrous oxide mixture of 60% and 40% respectively. Minimum&#xD;
      Alveolar Concentration (MAC) will be kept between 1.0-2 %. Patients receiving any opioids or&#xD;
      antiemetic will be excluded from the study. Intraoperative details of fluids will be noted&#xD;
      (total volume and type of fluid). After completion of surgery, supraglottic airway device&#xD;
      will be removed deep or awake at the discretion of primary anesthetist and patient will be&#xD;
      shifted to the recovery. In PACU and day care ward, child will be assessed for vomiting by&#xD;
      recording the number of episode of vomiting and for pain using Wong Baker FACES pain&#xD;
      scale.The time of breaking NPO and type of first feed will be noted. Patient will be followed&#xD;
      postoperatively for a period of 12 hours for any episodes of vomiting and pain in PACU and on&#xD;
      the daycare ward. The decision of breaking NPO will be based on the current practice of&#xD;
      pediatric surgeons and will not be interfered with.&#xD;
&#xD;
      Criteria for discharge from the PACU will include full consciousness, adequate pain control&#xD;
      determined using Wong Baker FACES pain scale (pain score of less than 4), no bleeding, stable&#xD;
      vital signs, and no vomiting. These patients will be followed up initially till discharge&#xD;
      from daycare ward. Later, the child will be followed up postoperatively on second day via&#xD;
      phone call to the parents for the occurrence of any pain and vomiting and parental&#xD;
      satisfaction with the anesthesia will also be asked. These results will be correlated with&#xD;
      the length of fasting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative feeding practice</measure>
    <time_frame>immediately after surgery to 24 hours after surgery</time_frame>
    <description>adverse outcomes after restarting feeding postoperatively will be assessed</description>
  </primary_outcome>
  <enrollment type="Anticipated">145</enrollment>
  <condition>Post-Op Complication</condition>
  <eligibility>
    <study_pop>
      <textblock>
        children aged between 2-10 years of age and ASA (American Society of Anesthesiologist)&#xD;
        classification I or II, undergoing infra-umblical daycare surgery under general anesthesia&#xD;
        combined with caudal block will be enrolled in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatrics patients undergoing infra-umbilical elective daycare surgery under general&#xD;
             anesthesia combined with caudal block&#xD;
&#xD;
          -  Age group 2 years to 10 years&#xD;
&#xD;
          -  ASA (American Society of Anesthesiologist) classification I or II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pediatric patient who would require postoperative fasting for surgical reasons&#xD;
&#xD;
          -  Patients with any known digestive pathology predisposing to post-operative vomiting&#xD;
             (e.g. hiatal hernia and gastro-esophageal reflux)&#xD;
&#xD;
          -  Patients receiving anti-emetic medications during the intraoperative period&#xD;
&#xD;
          -  Patients receiving opioids during the intraoperative period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
  </eligibility>
  <reference>
    <citation>Rizalar S, Ozbas A. Effect of Early Postoperative Feeding on the Recovery of Children Post Appendectomy. Gastroenterol Nurs. 2018 Mar/Apr;41(2):131-140. doi: 10.1097/SGA.0000000000000279.</citation>
    <PMID>29596127</PMID>
  </reference>
  <reference>
    <citation>Radke OC, Biedler A, Kolodzie K, Cakmakkaya OS, Silomon M, Apfel CC. The effect of postoperative fasting on vomiting in children and their assessment of pain. Paediatr Anaesth. 2009 May;19(5):494-9. doi: 10.1111/j.1460-9592.2009.02974.x.</citation>
    <PMID>19453581</PMID>
  </reference>
  <reference>
    <citation>Chauvin C, Schalber-Geyer AS, Lefebvre F, Bopp C, Carrenard G, Marcoux L, Mayer JF, Schwaab C, Joshi GP, Diemunsch P. Early postoperative oral fluid intake in paediatric day case surgery influences the need for opioids and postoperative vomiting: a controlled randomized trialdagger. Br J Anaesth. 2017 Mar 1;118(3):407-414. doi: 10.1093/bja/aew463.</citation>
    <PMID>28203729</PMID>
  </reference>
  <reference>
    <citation>Liechti M, Feurer R, Gross D, Schmitz A, Stutz K, Gerber A, Weiss M. Prevention of postoperative nausea and vomiting in children following adenotonsillectomy, using tropisetron with or without low-dose dexamethasone. J Anesth. 2007;21(3):311-6. doi: 10.1007/s00540-007-0523-0. Epub 2007 Aug 1.</citation>
    <PMID>17680180</PMID>
  </reference>
  <reference>
    <citation>Kranke P, Eberhart LH, Toker H, Roewer N, Wulf H, Kiefer P. A prospective evaluation of the POVOC score for the prediction of postoperative vomiting in children. Anesth Analg. 2007 Dec;105(6):1592-7, table of contents. doi: 10.1213/01.ane.0000287816.44124.03.</citation>
    <PMID>18042855</PMID>
  </reference>
  <reference>
    <citation>Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.</citation>
    <PMID>26757238</PMID>
  </reference>
  <reference>
    <citation>Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.</citation>
    <PMID>30877144</PMID>
  </reference>
  <reference>
    <citation>Shaikh SI, Nagarekha D, Hegade G, Marutheesh M. Postoperative nausea and vomiting: A simple yet complex problem. Anesth Essays Res. 2016 Sep-Dec;10(3):388-396. doi: 10.4103/0259-1162.179310.</citation>
    <PMID>27746521</PMID>
  </reference>
  <reference>
    <citation>Marulasiddappa V, Nethra HN. A Survey on Awareness about the Role of Anesthesia and Anesthesiologists among the Patients Undergoing Surgeries in a Tertiary Care Teaching Women and Children Hospital. Anesth Essays Res. 2017 Jan-Mar;11(1):144-150. doi: 10.4103/0259-1162.186595.</citation>
    <PMID>28298774</PMID>
  </reference>
  <reference>
    <citation>Thomas M, Morrison C, Newton R, Schindler E. Consensus statement on clear fluids fasting for elective pediatric general anesthesia. Paediatr Anaesth. 2018 May;28(5):411-414. doi: 10.1111/pan.13370. Epub 2018 Apr 27.</citation>
    <PMID>29700894</PMID>
  </reference>
  <reference>
    <citation>Brunet-Wood K, Simons M, Evasiuk A, Mazurak V, Dicken B, Ridley D, Larsen B. Surgical fasting guidelines in children: Are we putting them into practice? J Pediatr Surg. 2016 Aug;51(8):1298-302. doi: 10.1016/j.jpedsurg.2016.04.006. Epub 2016 Apr 21.</citation>
    <PMID>27166876</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University Hospital, Pakistan</investigator_affiliation>
    <investigator_full_name>Summiya Nafees Siddiqui</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <!-- 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/NCT04479215
org study id: 2020-3509-11353
nct id: NCT04479215
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is aimed to only observe the feeding practices after surgery in children
      undergoing below umbilicus surgery in day care and any impact of length of fasting on
      vomiting after surgery. If the child meets the criteria for being included in this study, the
      parents will be provided with informed consent form at the time of arrival at the daycare
      unit or at the time of arrival in the waiting area of the operating room. If parents agree
      and sign the consent form, then the child will be included in the study. The length of
      fasting period after the surgery and any episode of vomiting from after surgery till
      discharge time to home, will be recorded on a printed form. The nature of this study is only
      observation and the child will not be subjected to any new technique or medications. Parents
      will also be contacted on the next day of surgery on the phone number for any further
      observation about the child's feeding and vomiting and parental satisfaction with the
      anesthesia given will also be asked.
After approval from the departmental research committee and College of Physicians and
      Surgeons Pakistan (CPSP), all pediatric patients fulfilling the inclusion criteria undergoing
      elective outpatient infra-umbilical surgery under general anesthesia combined with caudal
      analgesia at Aga Khan University Hospital would be enrolled for this study. Informed parental
      consent will be taken after explaining the purpose and procedure of the study.

      All patients will be assessed preoperatively for anesthesia fitness by history, physical
      examination and laboratory investigations. On arrival on the day of surgery, patient will be
      premedicated with midazolam 0.3mg/kg, 30-45 minutes before the procedure. The following
      information including age, gender, weight, ASA status, time of last oral intake, preoperative
      fasting duration, surgical procedure, any history of POV with prior surgery and history of
      POV in parents or siblings will also be noted preoperatively. Patients at high risk of POV
      will not be included in the study as prophylactic antiemetic is needed to be given to such
      patients. Once the patient is taken into the operation room, standard ASA monitoring
      including electrocardiography, non-invasive blood pressure and pulse oximetry will be
      applied. Mode of induction will be inhalational with 8% sevoflurane and 100% oxygen or
      intravenous with propofol 2.5-3mg/kg. Airway will be secured with a supraglottic device
      appropriate to the weight of the patient. Patient will be positioned for caudal block which
      will be performed using small gauge butterfly cannula using 0.25% ropivacaine in a dosage of
      1ml/kg body weight with a maximum safe dose of 3mg/kg. Maintenance will be achieved with
      isoflurane in an oxygen and nitrous oxide mixture of 60% and 40% respectively. Minimum
      Alveolar Concentration (MAC) will be kept between 1.0-2 %. Patients receiving any opioids or
      antiemetic will be excluded from the study. Intraoperative details of fluids will be noted
      (total volume and type of fluid). After completion of surgery, supraglottic airway device
      will be removed deep or awake at the discretion of primary anesthetist and patient will be
      shifted to the recovery. In PACU and day care ward, child will be assessed for vomiting by
      recording the number of episode of vomiting and for pain using Wong Baker FACES pain
      scale.The time of breaking NPO and type of first feed will be noted. Patient will be followed
      postoperatively for a period of 12 hours for any episodes of vomiting and pain in PACU and on
      the daycare ward. The decision of breaking NPO will be based on the current practice of
      pediatric surgeons and will not be interfered with.

      Criteria for discharge from the PACU will include full consciousness, adequate pain control
      determined using Wong Baker FACES pain scale (pain score of less than 4), no bleeding, stable
      vital signs, and no vomiting. These patients will be followed up initially till discharge
      from daycare ward. Later, the child will be followed up postoperatively on second day via
      phone call to the parents for the occurrence of any pain and vomiting and parental
      satisfaction with the anesthesia will also be asked. These results will be correlated with
      the length of fasting.
observational model: Other
time perspective: Prospective
measure: postoperative feeding practice
time frame: immediately after surgery to 24 hours after surgery
description: adverse outcomes after restarting feeding postoperatively will be assessed
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 10 Years
citation: Rizalar S, Ozbas A. Effect of Early Postoperative Feeding on the Recovery of Children Post Appendectomy. Gastroenterol Nurs. 2018 Mar/Apr;41(2):131-140. doi: 10.1097/SGA.0000000000000279.
PMID: 29596127
citation: Radke OC, Biedler A, Kolodzie K, Cakmakkaya OS, Silomon M, Apfel CC. The effect of postoperative fasting on vomiting in children and their assessment of pain. Paediatr Anaesth. 2009 May;19(5):494-9. doi: 10.1111/j.1460-9592.2009.02974.x.
PMID: 19453581
citation: Chauvin C, Schalber-Geyer AS, Lefebvre F, Bopp C, Carrenard G, Marcoux L, Mayer JF, Schwaab C, Joshi GP, Diemunsch P. Early postoperative oral fluid intake in paediatric day case surgery influences the need for opioids and postoperative vomiting: a controlled randomized trialdagger. Br J Anaesth. 2017 Mar 1;118(3):407-414. doi: 10.1093/bja/aew463.
PMID: 28203729
citation: Liechti M, Feurer R, Gross D, Schmitz A, Stutz K, Gerber A, Weiss M. Prevention of postoperative nausea and vomiting in children following adenotonsillectomy, using tropisetron with or without low-dose dexamethasone. J Anesth. 2007;21(3):311-6. doi: 10.1007/s00540-007-0523-0. Epub 2007 Aug 1.
PMID: 17680180
citation: Kranke P, Eberhart LH, Toker H, Roewer N, Wulf H, Kiefer P. A prospective evaluation of the POVOC score for the prediction of postoperative vomiting in children. Anesth Analg. 2007 Dec;105(6):1592-7, table of contents. doi: 10.1213/01.ane.0000287816.44124.03.
PMID: 18042855
citation: Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.
PMID: 26757238
citation: Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.
PMID: 30877144
citation: Shaikh SI, Nagarekha D, Hegade G, Marutheesh M. Postoperative nausea and vomiting: A simple yet complex problem. Anesth Essays Res. 2016 Sep-Dec;10(3):388-396. doi: 10.4103/0259-1162.179310.
PMID: 27746521
citation: Marulasiddappa V, Nethra HN. A Survey on Awareness about the Role of Anesthesia and Anesthesiologists among the Patients Undergoing Surgeries in a Tertiary Care Teaching Women and Children Hospital. Anesth Essays Res. 2017 Jan-Mar;11(1):144-150. doi: 10.4103/0259-1162.186595.
PMID: 28298774
citation: Thomas M, Morrison C, Newton R, Schindler E. Consensus statement on clear fluids fasting for elective pediatric general anesthesia. Paediatr Anaesth. 2018 May;28(5):411-414. doi: 10.1111/pan.13370. Epub 2018 Apr 27.
PMID: 29700894
citation: Brunet-Wood K, Simons M, Evasiuk A, Mazurak V, Dicken B, Ridley D, Larsen B. Surgical fasting guidelines in children: Are we putting them into practice? J Pediatr Surg. 2016 Aug;51(8):1298-302. doi: 10.1016/j.jpedsurg.2016.04.006. Epub 2016 Apr 21.
PMID: 27166876
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University Hospital, Pakistan
investigator full name: Summiya Nafees Siddiqui
investigator title: Professor
mesh term: Vomiting
mesh term: Postoperative Complications