Pectus Excavatum
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTNew 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.
Sponsors
Jung Min Koo
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified-Yale Preoperative Anxiety Scale | Preoperatively at the surgery waiting room | 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. |
| Emergence delirium | 5 Minutes postoperatively at postoperative discharge unit | 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. |
| Pain Score | 5 minutes postoperatively at postoperative discharge unit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores | Between 1~6 hours postoperatively | 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. |
| Other pro re nata analgesics used, amount and type | Between 1~6 hours postoperatively | Analgesics applied in the ward according to the child's pain scale or as requested by his or her parents |
| Any postoperative side effects | Between 1~6 hours postoperatively | — |
Countries
South Korea
Contacts
Primary ContactJung Min Koo, MD
Outcome results
None listed