Post-Op ComplicationNCT04479215
Feeding Practices After the Surgery and Incidence of Vomiting
An observational study of Post-Op Complication, run by Aga Khan University Hospital, Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Post-Op Complication
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- Child
Study population: children aged between 2-10 years of age and ASA (American Society of Anesthesiologist) classification I or II, undergoing infra-umblical daycare surgery under general anesthesia combined with caudal block will be enrolled in the study.
Who may be able to join
- Pediatrics patients undergoing infra-umbilical elective daycare surgery under general anesthesia combined with caudal block
- Age group 2 years to 10 years
- ASA (American Society of Anesthesiologist) classification I or II
Who cannot join
- Pediatric patient who would require postoperative fasting for surgical reasons
- Patients with any known digestive pathology predisposing to post-operative vomiting (e.g. hiatal hernia and gastro-esophageal reflux)
- Patients receiving anti-emetic medications during the intraoperative period
- Patients receiving opioids during the intraoperative period
About this study
Official title: Postoperative Feeding Practice and Its Effect on Postoperative Vomiting in Children Undergoing Infra-umbilical Daycare Surgery: A Prospective Observational Study
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.
Read the detailed description
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.
- Conditions
- Post-Op Complication
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative feeding practice
adverse outcomes after restarting feeding postoperatively will be assessed
Measured: immediately after surgery to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study startJul 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Post-Op ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Summiya Nafees Siddiqui, Aga Khan University Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479215
- Sponsor's protocol ID
- 2020-3509-11353
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29596127Radke 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.
PubMed 19453581Chauvin 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.
PubMed 28203729Liechti 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.
PubMed 17680180Kranke 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.
PubMed 18042855Nelson 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.
PubMed 26757238Nelson 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.
PubMed 30877144Shaikh 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.
PubMed 27746521Marulasiddappa 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.
PubMed 28298774Thomas 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.
PubMed 29700894Brunet-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.
PubMed 27166876
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Feeding Practice and Its Effect on Postoperative Vomiting in Children Undergoing Infra-umbilical Daycare Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04479215
- Acronym / sponsor ID
- 2020-3509-11353
- Conditions
- Post-Op Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Aga Khan University Hospital, PakistanUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Age groups
- Child
- Study population
- children aged between 2-10 years of age and ASA (American Society of Anesthesiologist) classification I or II, undergoing infra-umblical daycare surgery under general anesthesia combined with caudal block will be enrolled in the study.
Key inclusion criteria (3 listed)
- Pediatrics patients undergoing infra-umbilical elective daycare surgery under general anesthesia combined with caudal block
- Age group 2 years to 10 years
- ASA (American Society of Anesthesiologist) classification I or II
Key exclusion criteria (4 listed)
- Pediatric patient who would require postoperative fasting for surgical reasons
- Patients with any known digestive pathology predisposing to post-operative vomiting (e.g. hiatal hernia and gastro-esophageal reflux)
- Patients receiving anti-emetic medications during the intraoperative period
- Patients receiving opioids during the intraoperative period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative feeding practice
Time frame: immediately after surgery to 24 hours after surgery
adverse outcomes after restarting feeding postoperatively will be assessed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Background: PubMed 29596127Rizalar 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.
- Background: PubMed 19453581Radke 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.
- Background: PubMed 28203729Chauvin 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.
- Background: PubMed 17680180Liechti 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.
- Background: PubMed 18042855Kranke 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.
- Background: PubMed 26757238Nelson 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.
- Background: PubMed 30877144Nelson 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.
- Background: PubMed 27746521Shaikh 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.
- Background: PubMed 28298774Marulasiddappa 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.
- Background: PubMed 29700894Thomas 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.
- Background: PubMed 27166876Brunet-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Op Complication, run by Aga Khan University Hospital, Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative feeding practice (time frame: immediately after surgery to 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04479215, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.