An interventional study of New Care No Nil Per Os in Pectus Excavatum, sponsored by Jung Min Koo. Status unknown at 1 site in Korea, Republic of. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2020-03-19.
Sponsored by Jung Min Koo · Not applicable, Interventional, and Supportive care
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.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's planned enrollment of 90 is above the median of 40 across 46 interventional studies indexed under Funnel Chest.
Browse Funnel Chest studies →Jung Min Koo is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Routine preoperative fasting group undergoes 8 hours of fasting before the operation.
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
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 minutes postoperatively at postoperative discharge unit
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Between 24~48 hours postoperatively
Any postoperative side effects
Time frame: Between 1~6 hours postoperatively
Any postoperative side effects
Time frame: Between 12~24 hours postoperatively
Any postoperative side effects
Time frame: Between 24~48 hours postoperatively
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2019 (actual). Primary completion is estimated for Jan 2021, 16 months after the start.
Of 31 interventional studies with no phase under Funnel Chest, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 68. This study's planned 16 months is below that.
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This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Jung Min Koo