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

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ClinicalTrials.gov Identifier: NCT04068324
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Jung Min Koo, Seoul St. Mary's Hospital

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.


Condition or disease Intervention/treatment Phase
Pectus Excavatum Dietary Supplement: New Care No Nil Per Os Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison of Postoperative Recovery After Preoperative Carbohydrate Loading With Standard Fasting in Pediatric Patients Undergoing Nuss Operation
Actual Study Start Date : August 30, 2019
Estimated Primary Completion Date : January 28, 2021
Estimated Study Completion Date : February 28, 2021

Arm Intervention/treatment
No Intervention: 8 hours fasting group
Routine preoperative fasting group undergoes 8 hours of fasting before the operation.
Experimental: Clear liquid group
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
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.

Experimental: Carbohydrate containing liquid group
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.




Primary Outcome Measures :
  1. Modified-Yale Preoperative Anxiety Scale [ Time Frame: 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.

  2. Emergence delirium [ Time Frame: 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.

  3. Emergence delirium [ Time Frame: 10 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.

  4. Emergence delirium [ Time Frame: 15 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.

  5. Emergence delirium [ Time Frame: 30 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.

  6. Emergence delirium [ Time Frame: 45 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.

  7. Emergence delirium [ Time Frame: 60 Minutes postoperatively ]
    "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.

  8. Pain Score [ Time Frame: 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.

  9. Pain Score [ Time Frame: 10 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.

  10. Pain Score [ Time Frame: 15 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.

  11. Pain Score [ Time Frame: 30 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 Outcome Measures :
  1. Pain scores [ Time Frame: 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.

  2. Pain scores [ Time Frame: Between 12~24 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.

  3. Pain scores [ Time Frame: Between 24~48 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.

  4. Other pro re nata analgesics used, amount and type [ Time Frame: 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

  5. Other pro re nata analgesics used, amount and type [ Time Frame: Between 12~24 hours postoperatively ]
    Analgesics applied in the ward according to the child's pain scale or as requested by his or her parents

  6. Other pro re nata analgesics used, amount and type [ Time Frame: Between 24~48 hours postoperatively ]
    Analgesics applied in the ward according to the child's pain scale or as requested by his or her parents

  7. Any postoperative side effects [ Time Frame: Between 1~6 hours postoperatively ]
  8. Any postoperative side effects [ Time Frame: Between 12~24 hours postoperatively ]
  9. Any postoperative side effects [ Time Frame: Between 24~48 hours postoperatively ]


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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068324


Contacts
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Contact: Jung Min Koo, MD +821051685538 miniyaa623@gmail.com

Locations
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Korea, Republic of
Jung Min Koo Recruiting
Seoul, Korea, Republic of
Contact: Jung Min Koo, MD    +821051685538    miniyaa623@gmail.com   
Sponsors and Collaborators
Jung Min Koo
Investigators
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Principal Investigator: Jung Min Koo, MD Seoul St. Mary's Hospital, South Korea
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Responsible Party: Jung Min Koo, Principal Investigator, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT04068324    
Other Study ID Numbers: KC19ENSI0335
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Funnel Chest
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities