Caregivers and Resident Doctors' Perceptions of Preoperative Fasting in Children

NCT03273517 | Unknown DMC

• 1 other identifier: 58080016.8.0000.5472
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Historically, adults and children who undergo elective surgery remain fasting in the preoperative period, for the purposes of avoiding bronchial aspiration of the gastric contents during general anesthesia. The determination of preoperative fasting has taken on importance only in 1946, when Mendelson established a relationship between pulmonary aspiration during labor and general anesthesia. Stemming from other studies, such concept has been expanded to elective surgery and 25 ml were set as the maximum threshold of the gastric content to thus reduce the hazards of aspiration pneumonia. The fasting time prescribed is still the subject of several investigations. For decades it has been established that patients should not feed on solids or ingest liquids over a period of 8 to 12 hours prior to surgery. The guidelines are well set in connection with the rules of fasting, with aims at making the instructions constant throughout different services worldwide. In 2011, the American and the European guidelines became more permissive and determined as safe the 2 hours for liquids devoid of residue, 4 hours for breast milk, 6 hours for infant formula and non-human milk, 6 hours for light meals, and 8 hours for full meals. In accordance with the American guideline, liquids devoid of residue are: water, fruit juice with no pulp, carbohydrate-based beverages, tea with no residue, and black coffee, but those examples are not extensive. Gelatin is solid prior to intake, but it is found in a liquid state inside the stomach and, therefore, it is regarded as a liquid devoid of residue. Yet, in spite of the non-human milk's being a liquid material, it features a gastric emptying time which is similar to that of the non-fat solids. A light meal is characterized by toast and liquids devoid of residue, whilst a full meal includes food that is fried or which contains a high level of fat. Currently, many directives (American Society of Anaesthesiologists - ASA; Norwegian National Consensus Guideline - NNCG; Association of Anaesthetists of Great Britain and Ireland - AAGBI) recommend liquids devoid of residue until two hours prior to the anesthetic induction for elective surgery in healthy children. The particular benefit of the oral intake of fluids includes a lower incidence of deleterious effects, such as thirst, irritation, crying, hypoglycemia, and dehydration. The preservation of the intravascular volume improves the hemodynamic conditions during the induction of inhalation anesthesia and facilitates the vascular access. Even though the old instruction of "nothing by mouth after midnight" is in a process of being replaced by shorter periods of fasting, both surgeons and anesthesiologists still deem the traditional fast indispensable and have trouble with implementing the new norms, either by uncertainty before the possibility of the catastrophic consequences of pulmonary aspiration, or by lack of update on the subject. That matter generates mistakes in the rendering of information by the health professionals. Combined with the unawareness of the guardians in respect of the risk of bronchial aspiration and the anxiety in relation to the fasting, there is a result of difficulty in abidance by the proper preoperative fasting. The minority of the guardians understands the real importance of the preoperative fasting and, many times, food regarded as "harmless" is offered during the period of fasting. Likewise, the guardians provide improper information in order to maintain the surgical procedure, with no regard for the correct observance of the fasting. That way, countless pediatric elective surgeries are canceled, deriving in psychological, social, and economic implications. The correction of these flaws will allow for the anesthetic procedure to take place in a more secure manner, with the proper observance of the fasting period and with the least possible trauma to the child.

Conditions

Fasting

Keywords

Glycemia; Preoperative fasting; Pediatric patients; Anesthesia; Knowledge of the resident

Outcome Measures

Primary Outcomes (2)

• Glycemia

  After the anesthetic induction, the patients will be subject to the measurement of blood glucose by Dextro.

  An average of 1 hour after induction of general anesthesia

• The understanding and the perception of the guardians in relation to the importance of fasting in pediatric patients

  The questionnaires will be applied to the guardians of the children who have undergone imaging examination and elective surgery

  1 hour after post-anesthetic

Secondary Outcomes (1)

• Knowledge of the resident doctors

  Through study completion, an average of 1 year

Interventions

Elective surgery PROCEDURE

Elective surgery in children aged 0-15 years ASA I and II

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

* Children below 15 years of age, subject to ophthalmological, otorhinolaryngological, orthopedic, and pediatric elective surgery and imaging examinations, with ASA I and II physical condition, and their guardians, over a period of three months. * Resident doctors of the specialties of general and pediatric surgery, ophthalmology, otorhinolaryngology, anesthesia, general orthopedics, a pediatric orthopedics.

You may qualify if:

• Literate parents or guardians;
• Children with indication for general anesthesia;
• Children between 0 and 15 years of age;
• Children with ASA I and II physical condition.
• Resident doctors of the specialties of general and pediatric surgery, ophthalmology, otorhinolaryngology, anesthesia, general orthopedics, a pediatric orthopedics.

You may not qualify if:

• Children subject to anesthetic induction by means of the rapid sequence technique.
• Children with alterations in the gastric emptying (diabetes, obesity, neonatal hypoxic encephalopathy, usage of gastrostomy and of nasogastric and nasoenteric probes).

Sponsors & Collaborators

• Faculdade de Ciências Médicas da Santa Casa de São Paulo: lead

Study Sites (1)

Santa Casa of São Paulo Medical School

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (13)

• Buller Y, Sims C. Prolonged fasting of children before anaesthesia is common in private practice. Anaesth Intensive Care. 2016 Jan;44(1):107-10. doi: 10.1177/0310057X1604400116.

  PMID: 26673596 RESULT

• Cantellow S, Lightfoot J, Bould H, Beringer R. Parents' understanding of and compliance with fasting instruction for pediatric day case surgery. Paediatr Anaesth. 2012 Sep;22(9):897-900. doi: 10.1111/j.1460-9592.2012.03903.x. Epub 2012 Jun 25.

  PMID: 22731386 RESULT

• Cook-Sather SD, Litman RS. Modern fasting guidelines in children. Best Pract Res Clin Anaesthesiol. 2006 Sep;20(3):471-81. doi: 10.1016/j.bpa.2006.02.003.

  PMID: 17080697 RESULT

• Flick RP, Schears GJ, Warner MA. Aspiration in pediatric anesthesia: is there a higher incidence compared with adults? Curr Opin Anaesthesiol. 2002 Jun;15(3):323-7. doi: 10.1097/00001503-200206000-00008.

  PMID: 17019220 RESULT

• Green CR, Pandit SK, Schork MA. Preoperative fasting time: is the traditional policy changing? Results of a national survey. Anesth Analg. 1996 Jul;83(1):123-8. doi: 10.1097/00000539-199607000-00022.

  PMID: 8659722 RESULT

• Kushnir J, Djerassi R, Sofer T, Kushnir T. Threat perception, anxiety and noncompliance with preoperative fasting instructions among mothers of children attending elective same day surgery. J Pediatr Surg. 2015 May;50(5):869-74. doi: 10.1016/j.jpedsurg.2014.08.018. Epub 2014 Oct 1.

  PMID: 25783336 RESULT

• MENDELSON CL. The aspiration of stomach contents into the lungs during obstetric anesthesia. Am J Obstet Gynecol. 1946 Aug;52:191-205. doi: 10.1016/s0002-9378(16)39829-5. No abstract available.

  PMID: 20993766 RESULT

• Moro ET. [Prevention of pulmonary gastric contents aspiration.]. Rev Bras Anestesiol. 2004 Apr;54(2):261-75. doi: 10.1590/s0034-70942004000200014. Portuguese.

  PMID: 19471734 RESULT

• Ramirez-Mora J, Moyao-Garcia D, Nava-Ocampo AA. Attitudes of Mexican anesthesiologists to indicate preoperative fasting periods: A cross-sectional survey. BMC Anesthesiol. 2002 May 17;2(1):3. doi: 10.1186/1471-2253-2-3.

  PMID: 12019024 RESULT

• Schreiner MS, Triebwasser A, Keon TP. Ingestion of liquids compared with preoperative fasting in pediatric outpatients. Anesthesiology. 1990 Apr;72(4):593-7. doi: 10.1097/00000542-199004000-00002.

  PMID: 2321772 RESULT

• Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.

  PMID: 21712716 RESULT

• Warner MA. Is pulmonary aspiration still an important problem in anesthesia? Curr Opin Anaesthesiol. 2000 Apr;13(2):215-8. doi: 10.1097/00001503-200004000-00023.

  PMID: 17016306 RESULT

• American Society of Anesthesiologists Committee. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures: an updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2011 Mar;114(3):495-511. doi: 10.1097/ALN.0b013e3181fcbfd9. No abstract available.

  PMID: 21307770 RESULT

MeSH Terms

Conditions

Fasting

Interventions

Elective Surgical Procedures

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Ligia Mathias, Doctor

CONTACT

+ 55 11 99386-0059; rtimao@uol.com.br

Débora de Oliveira Cumino

CONTACT

dcumino@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: September 6, 2017
• Study Start: August 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: November 1, 2017
• Last Updated: September 6, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)