Feeding Practices After the Surgery and Incidence of Vomiting

July 19, 2020 updated by: Summiya Nafees Siddiqui, Aga Khan University Hospital, Pakistan

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative feeding practice
Time Frame: immediately after surgery to 24 hours after surgery
adverse outcomes after restarting feeding postoperatively will be assessed
immediately after surgery to 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University Hospital, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

July 19, 2020

First Posted (Actual)

July 21, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 19, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-3509-11353

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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