Postoperative Recovery Quality According to Preoperative Fasting Time in Pediatric Patients Undergoing Nuss Operation

Comparison of Postoperative Recovery After Preoperative Carbohydrate Loading With Standard Fasting in Pediatric Patients Undergoing Nuss Operation

Preoperative fasting is intended to lower the amount of gastric contents in order to decrease the incidence of aspiration associated with endotracheal intubation. However, recent studies show that longer fasting time does not reduce aspiration associated complications. Especially in pediatric patients, long fasting time increases patients' unpleasantness and therefore increases postoperative recovery quality. It also induces hypoglycemia. In many studies, ingesting clear liquids 2 hours up to general anesthesia decreases gastric contents and therefore the incidence of aspiration pneumonia, postoperative nausea and vomiting. Therefore anesthesiologist associations in the US and Europe recommend to drink small amount of clear liquid (water) up to 2 hours before the surgery.

Nuss bar operation, or repair surgery of pectus excavatum is mostly done in pediatric patients. The procedure itself is very painful, requiring paramount amount of analgesics. Use of opioid analgesics increases postoperative nausea and vomiting.

In this study, our aim is to evaluate preoperative fasting time and how preoperative supplement of clear liquid affects the quality of recovery postoperatively.

Study Overview

• Status: Unknown
• Conditions: Pectus Excavatum
• Intervention / Treatment: Dietary supplement: New Care No Nil Per Os

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung Min Koo, MD; Phone Number: +821051685538; Email: miniyaa623@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Jung Min Koo
    • Contact: Jung Min Koo, MD; Phone Number: +821051685538; Email: miniyaa623@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Pediatric patients from age 3 to 6
2. Undergoing repair surgery for pectus excavatum
3. American Society of Anesthesiologists class I to III

Exclusion Criteria:

1. Any diseases or past surgical procedures involving gastrointestinal tract
2. Past history of psychiatric diseases
3. On chronic analgesic medication
4. Patients or Patients' caregivers do not agree to attend the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: 8 hours fasting group; Routine preoperative fasting group undergoes 8 hours of fasting before the operation.
EXPERIMENTAL: Clear liquid group; 30 pediatric patients drink 3ml/kg 1 hour before the surgery. Although "clear liquid" suggests any drinks that do not contain any solid ingredients, but in this study we define "clear liquid" as water.	Dietary supplement: New Care No Nil Per Os; The product name "NoNPO" is from South Korean company "Well life." It contains carbohydrate and is frequently used in preoperative fasting patients in order to alleviate patients' discomfort resulting from empty stomach and thirst. It is also known to decrease insulin resistant.
EXPERIMENTAL: Carbohydrate containing liquid group; Other 30 pediatric patients drink 3ml/kg of carbohydrate containing fluid 1 hour before the surgery. The product name we have is "NoNPO" from NewCare (South Korean company). This fluid does not contain any solid ingredients, so consuming the fluid does not exceed Nil per Os time needed before the surgery.	Dietary supplement: New Care No Nil Per Os; The product name "NoNPO" is from South Korean company "Well life." It contains carbohydrate and is frequently used in preoperative fasting patients in order to alleviate patients' discomfort resulting from empty stomach and thirst. It is also known to decrease insulin resistant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified-Yale Preoperative Anxiety Scale	MyPas scale measures 4 categories: Activity, Vocalizations, Emotional Expressivity and State of Apprent Arousal. Each category has 1 to 4 scales for activity, emotional expresivity and state of apprent arousal, and 1 to 6 for vocalizations, that each describes the child's anxiety status. The observer collects total score ranging from 4 to 18.	Preoperatively at the surgery waiting room
Emergence delirium	"Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.	5 Minutes postoperatively at postoperative discharge unit
Emergence delirium	"Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.	10 Minutes postoperatively at postoperative discharge unit
Emergence delirium	"Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.	15 Minutes postoperatively at postoperative discharge unit
Emergence delirium	"Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.	30 Minutes postoperatively at postoperative discharge unit
Emergence delirium	"Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.	45 Minutes postoperatively at postoperative discharge unit
Emergence delirium	"Watcha scale" measures child's postoperative delirium at the recovery center. The total score ranges from 0 to 4. 0 is when the child is asleep, 1 is calm and sedated, 2 is when the child is crying but consolable, 3 is when the child is crying and unconsolable, and 4 is when the child is uncontrollable.	60 Minutes postoperatively
Pain Score	Face, Legs, Activity, Cry and Consolability score: This is a measurement for pediatric pain. The observer observes the child's face, legs, activity, cry and consolability. The score ranges from 0 to maximum of 8. 0 is when the child is calm without any pain, and 8 being the most painful expression of the child.	5 minutes postoperatively at postoperative discharge unit
Pain Score	Face, Legs, Activity, Cry and Consolability score: This is a measurement for pediatric pain. The observer observes the child's face, legs, activity, cry and consolability. The score ranges from 0 to maximum of 8. 0 is when the child is calm without any pain, and 8 being the most painful expression of the child.	10 minutes postoperatively at postoperative discharge unit
Pain Score	Face, Legs, Activity, Cry and Consolability score: This is a measurement for pediatric pain. The observer observes the child's face, legs, activity, cry and consolability. The score ranges from 0 to maximum of 8. 0 is when the child is calm without any pain, and 8 being the most painful expression of the child.	15 minutes postoperatively at postoperative discharge unit
Pain Score	Face, Legs, Activity, Cry and Consolability score: This is a measurement for pediatric pain. The observer observes the child's face, legs, activity, cry and consolability. The score ranges from 0 to maximum of 8. 0 is when the child is calm without any pain, and 8 being the most painful expression of the child.	30 minutes postoperatively at postoperative discharge unit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Face, Legs, Activity, Cry and Consolability score: This is a measurement for pediatric pain. The observer observes the child's face, legs, activity, cry and consolability. The score ranges from 0 to maximum of 8. 0 is when the child is calm without any pain, and 8 being the most painful expression of the child.	Between 1~6 hours postoperatively
Pain scores	Face, Legs, Activity, Cry and Consolability score: This is a measurement for pediatric pain. The observer observes the child's face, legs, activity, cry and consolability. The score ranges from 0 to maximum of 8. 0 is when the child is calm without any pain, and 8 being the most painful expression of the child.	Between 12~24 hours postoperatively
Pain scores	Face, Legs, Activity, Cry and Consolability score: This is a measurement for pediatric pain. The observer observes the child's face, legs, activity, cry and consolability. The score ranges from 0 to maximum of 8. 0 is when the child is calm without any pain, and 8 being the most painful expression of the child.	Between 24~48 hours postoperatively
Other pro re nata analgesics used, amount and type	Analgesics applied in the ward according to the child's pain scale or as requested by his or her parents	Between 1~6 hours postoperatively
Other pro re nata analgesics used, amount and type	Analgesics applied in the ward according to the child's pain scale or as requested by his or her parents	Between 12~24 hours postoperatively
Other pro re nata analgesics used, amount and type	Analgesics applied in the ward according to the child's pain scale or as requested by his or her parents	Between 24~48 hours postoperatively
Any postoperative side effects		Between 1~6 hours postoperatively
Any postoperative side effects		Between 12~24 hours postoperatively
Any postoperative side effects		Between 24~48 hours postoperatively

Collaborators and Investigators

• Sponsor: Jung Min Koo
• Investigators: Principal Investigator: Jung Min Koo, MD, Seoul St. Mary's Hospital, South Korea

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 30, 2019
• Primary Completion (ANTICIPATED): January 28, 2021
• Study Completion (ANTICIPATED): February 28, 2021

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Funnel Chest
• Other Study ID Numbers: KC19ENSI0335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No