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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pectus Excavatum

Intervention / Treatment
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* Dietary Supplement: New Care No Nil Per Os


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients from age 3 to 6 Undergoing repair surgery for pectus excavatum American Society of Anesthesiologists class I to III Exclusion Criteria: Any diseases or past surgical procedures involving gastrointestinal tract Past history of psychiatric diseases On chronic analgesic medication Patients or Patients' caregivers do not agree to attend the study

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 8 hours fasting group<br>Routine preoperative fasting group undergoes 8 hours of fasting before the operation. | |
| Experimental: Clear liquid group<br>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<br>* 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.<br>|
| Experimental: Carbohydrate containing liquid group<br>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<br>* 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.<br>|

What is the study measuring?
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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 |