Clinical Trials Logo

Clinical Trial Summary

In 2018, the main societies of anesthesia (European Society Anaesthesiology, European Society Pediatric Anesthesia, and Association des Anesthésistes Réanimateurs Pédiatriques d'Expression Française) changed the current recommendations for preoperative fasting time in children, reducing the time to last intake of clear liquids from two to one hour before anesthetic induction. Prolonged fasting may have a deleterious impact on blood glucose homeostasis. The consequences of intraoperative hypoglycemia in children can be serious in the short term, but also in the long term. The objective of multicenter prospective, observational cohort study is to investigate- in children younger than 24 months of age undergoing scheduled conventional inpatient surgery- a correlation between the duration of preoperative fasting, glycemic intraoperative homeostasis and the criteria of enhanced recovery after surgery, which are the hospital length of stay (main outcome), postoperative pain and postoperative nausea-vomiting (secondary outcomes). By identifying non-adherence to fasting rules as one of the causes of prolonged hospitalization, this study will highlight the need to develop effective strategies to promote adherence to fasting rules in pediatric surgery and minimize the potential deleterious impact on intraoperative glycemic control.


Clinical Trial Description

Preoperative fasting instructions (6 hours for solids and formula, 4 hours for breast milk, and 1 hour for clear liquids) will be explained to parents orally during the preoperative anesthesia consultation and a written document, reminding them of these instructions, will be given to them afterwards. Upon arrival in the operating room, the anesthesiologist will record on a standardized collection sheet the time of fasting as well as the premedication received (time of paracetamol and/or ibuprofen, β2-mimetic aerosols, preoperative antibiotic therapy). After anesthetic induction, once airway management and securing of the peripheral venous line have been completed and before surgical setup, a capillary blood sample will be taken from the earlobe or fingertip to measure blood glucose and ketone levels using a blood glucose and ketone meter (FREESTYLE OPTIUM NEO H, ketone and blood sugar meter, calibration performed prior to the study by the pharmacology department). A ketonemia will be considered abnormally high if the ketone level is higher than 0.6 mmol/L (0.11g/L). Hypoglycemia will be defined as a capillary blood glucose level less than <3.5 mmol/L (0.63 g/L)9. In case of hypoglycemia or high ketonemia, a second capillary sample should be taken, taking care to change the sampling area (ear or finger) and then an average of the two results should be taken. Capillary blood glucose and ketone measurements are part of routine care in pediatric anesthesia. Therefore, there will be no additional cost. Intraoperative monitoring for all children will include a 3-lead ECG, pneumocardiograph, non-invasive blood pressure measurement, pulse oximetry (SpO2), esophageal or rectal temperature measurement, and capnography. A forced-air heating blanket will be used to warm the patient during the procedure. Mean arterial pressure (MAP) will be documented after induction of anesthesia, and hypotension will be defined as MAP < 45 mmHg7. Intraoperatively, data will be collected from the patient's blood pressure. Intraoperatively, the following data will be recorded on the standardized collection sheet: anesthetic agents used (hypnotics and morphinics), intraoperative analgesics, anti-nausea agents (dexamethasone, ondansetron), infusion fluids used (nature of the fluid, rate of infusion), catecholamine (ephedrine), drugs that may interfere with blood sugar regulation. In the recovery room, postoperative pain will be evaluated using the EVENDOL scale and by the consumption of analgesics (total dose of paracetamol, ibuprofen, nalbuphine). The treatment of postoperative nausea and vomiting, left to the discretion of the anaesthetist, will also be recorded (total dose of ondansetron, droperidol, others). After return to the department, the duration of hospitalization will be recorded. It will be defined as the number of days between arrival in the operating room and departure from the hospital. A clinically significant difference in length of stay will be considered a difference of at least 4 hours of hospital stay. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04826627
Study type Observational [Patient Registry]
Source University Hospital, Caen
Contact Jean-Philippe Salaün, MD
Phone +644295087
Email salaunjeanphilippe@gmail.com
Status Recruiting
Phase
Start date July 15, 2021
Completion date April 15, 2023

See also
  Status Clinical Trial Phase
Completed NCT06190457 - Safety and Efficacy of Intrathecal Rituximab in 16 Children of Stage Ⅲ、ⅣNon-Hodgkin Lymphoma
Recruiting NCT04691349 - CAR-T for r/r Malignant Tumors in Children Early Phase 1
Not yet recruiting NCT06455592 - Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years N/A
Not yet recruiting NCT05566951 - Technology-Based Psychosocial Empowerment Program for Home Care of Children With Cancer and Their Parents N/A
Not yet recruiting NCT05806983 - Evaluation of the Efficiency of the Technology-Based Psychosocial Empowerment Program Program N/A
Recruiting NCT05329467 - Validation of Pain Assessment Scale Faces Thermometer Scale (FTS) N/A
Not yet recruiting NCT04016506 - Epidemiology, Management and Complications Related to Pancreatic Trauma in Children
Recruiting NCT05761847 - Pediatric Medication Therapy Management Trial N/A
Not yet recruiting NCT06291012 - Stopping Pneumonia Antibiotherapy Regimen Early Phase 4
Not yet recruiting NCT05943587 - The Development and Evaluation of Pain Neuroscience Education in Children N/A
Recruiting NCT05109013 - Juvenile Essential Arterial Hypertension and Vascular Function
Completed NCT04846400 - Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia N/A
Completed NCT04040036 - Effects of Virtual Reality on Pain, Fear and Anxiety During Blood Draw in Children Aged 5-12 Years Old N/A
Completed NCT03312881 - Neuropathic Pain in Children: Multimodal Assessment and Diagnosis
Completed NCT04334733 - The Impact of Preprocedural Animation About Echocardiography Display and Kaleidoscope Display on Anxiety in Children N/A
Completed NCT06220383 - Evaluation of The Effect of Crowns Applied With Hall Technique on Occlusion N/A
Completed NCT03941392 - Nutritional Study in Spanish Pediatric Population
Completed NCT03244332 - HEMOCC Study. Hemostasis in Cirrhotic Children. N/A
Not yet recruiting NCT06299267 - The Effect of Dual Task on Manual Skill Performance in Children and Adolescents N/A
Active, not recruiting NCT04070131 - Horse Assisted Rehabilitation Postoncologic Treatment in Children and Adolescents: Physical and Psychological Effects N/A