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In the new guideline from ESAIC breast-feeding should be encouraged until 3 hours before anesthesia. This recommendation was based mainly on gastric emptying studies in neonates with small sample sizes and single center experience.To address the lack of high quality evidence for this recommendation, the ESAIC task force for preoperative fasting plans perform a multicenter RCT omparing 4 vs 3 hours of preoperative fasting for breast milk.
The aim of the present pilot-study is to provide data for sample size calculation and feasibility for the multicenter trial.
Since the publication of several studies indicating that many children are subjected to unnecessarily long fasting waiting for surgery, there is great interest within the pediatric anesthesia community to understand gastric emptying to be able to revise existing guidelines. The new recommendation from ESAIC is that breast-feeding should be encouraged until 3 hours before anesthesia. This recommendation was based mainly on gastric emptying studies in neonates with small sample sizes and single center experience.To address the lack of high quality evidence for this recommendation, the task force plans to perform a multicenter RCT comparing 4 vs 3 hours of preoperative fasting for breast milk.
Twenty infants scheduled for elective surgery or procedures requiring general anesthesia or sedation will be recruited for this randomized controlled pilot study.
Based on the randomization, they are then asked to breast-feed (or bottle-feed with breast-milk) the child at 4 or 3 hours before the scheduled anesthesia induction.
On arrival to the operating room, the gastric ultrasound examination will be performed for analysis of the gastric antrum CSA. After i.v. or inhalational anesthesia, an oro-gastric catheter will be inserted and any residual gastric contents are aspirated when rotating the infant from supine to semi-prone right and left positions. The volume and color of the aspirate will be recorded.
The aim of the present pilot-study is to provide data for sample size calculation and feasibility for the multicenter trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3h Group | Experimental | the patient's parents are instructed to stop feeding 3 hours for scheduled anesthesia. (3 hours of preoperative fasting for breast milk) |
|
| 4h Group | Active Comparator | the patient's parents are instructed to stop feeding 4 hours for scheduled anesthesia (4 hours of preoperative fasting for breast milk) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 hours of preoperative fasting for breast milk | Other | 3 hours of preoperative fasting for breast milk |
|
| Measure | Description | Time Frame |
|---|---|---|
| CSA | Gastric antrum CSA (The antral cross-sectional area) | From arrival in the operating room until induction of anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Aspirated volume | Aspirated volume | intraoperative |
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Inclusion Criteria:
- Breast-feeding infanta scheduled for elective procedure requiring general anesthesia
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Frykholm, MD, PhD | Uppsala University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala University Hospital | Uppsala | 75185 | Sweden |
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| Label | URL |
|---|---|
| Pre-operative fasting in children: A guideline from the European Society of Anaesthesiology and Intensive Care | View source |
| Gastric content assessed with gastric ultrasound in paediatric patients prescribed a light breakfast prior to general anaesthesia: A prospective observational study | View source |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Prospective randomized controlled pilot study
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Computerized randomization,
| 4 hours of preoperative fasting for breast milk | Other | 4 hours of preoperative fasting for breast milk |
|
| Ultrasound assessment of gastric emptying time after intake of clear fluids in children scheduled for general anesthesia-A prospective observational study | View source |
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |