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

Primary Purpose

Pectus Excavatum

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
New Care No Nil Per Os
Sponsored by
Jung Min Koo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pectus Excavatum

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jung Min KooRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

8 hours fasting group

Clear liquid group

Carbohydrate containing liquid group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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
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
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
Any postoperative side effects
Any postoperative side effects
Any postoperative side effects

Full Information

First Posted
August 20, 2019
Last Updated
March 18, 2020
Sponsor
Jung Min Koo
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1. Study Identification

Unique Protocol Identification Number
NCT04068324
Brief Title
Postoperative Recovery Quality According to Preoperative Fasting Time in Pediatric Patients Undergoing Nuss Operation
Official Title
Comparison of Postoperative Recovery After Preoperative Carbohydrate Loading With Standard Fasting in Pediatric Patients Undergoing Nuss Operation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2019 (Actual)
Primary Completion Date
January 28, 2021 (Anticipated)
Study Completion Date
February 28, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jung Min Koo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
8 hours fasting group
Arm Type
No Intervention
Arm Description
Routine preoperative fasting group undergoes 8 hours of fasting before the operation.
Arm Title
Clear liquid group
Arm Type
Experimental
Arm Description
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.
Arm Title
Carbohydrate containing liquid group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
New Care No Nil Per Os
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified-Yale Preoperative Anxiety Scale
Description
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
Title
Emergence delirium
Description
"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
Title
Emergence delirium
Description
"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
Title
Emergence delirium
Description
"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
Title
Emergence delirium
Description
"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
Title
Emergence delirium
Description
"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
Title
Emergence delirium
Description
"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
Title
Pain Score
Description
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
Title
Pain Score
Description
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
Title
Pain Score
Description
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
Title
Pain Score
Description
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
Secondary Outcome Measure Information:
Title
Pain scores
Description
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
Title
Pain scores
Description
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
Title
Pain scores
Description
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
Title
Other pro re nata analgesics used, amount and type
Description
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
Title
Other pro re nata analgesics used, amount and type
Description
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
Title
Other pro re nata analgesics used, amount and type
Description
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
Title
Any postoperative side effects
Time Frame
Between 1~6 hours postoperatively
Title
Any postoperative side effects
Time Frame
Between 12~24 hours postoperatively
Title
Any postoperative side effects
Time Frame
Between 24~48 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung Min Koo, MD
Phone
+821051685538
Email
miniyaa623@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Min Koo, MD
Organizational Affiliation
Seoul St. Mary's Hospital, South Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jung Min Koo
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Min Koo, MD
Phone
+821051685538
Email
miniyaa623@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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