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

Pectus Excavatum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04068324
• Other study ID #: KC19ENSI0335
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2020
• Source: Seoul St. Mary's Hospital
• Contact: Jung Min Koo, MD
• Phone: +821051685538
• Email: miniyaa623[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 28, 2021
• Est. primary completion date: January 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Funnel Chest
• Pectus Excavatum

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Jung Min Koo	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jung Min Koo

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Any postoperative side effects		Between 1~6 hours postoperatively
Secondary	Any postoperative side effects		Between 12~24 hours postoperatively
Secondary	Any postoperative side effects		Between 24~48 hours postoperatively