Parents' perception and factors affecting compliance with preoperative fasting instructions in children undergoing day care surgery: A prospective observational study.

BACKGROUND AND AIMS: Fasting guidelines have been recommended in the paediatric population to minimise the risk of pulmonary aspiration. The present study was planned to assess the compliance with fasting instructions in children undergoing ambulatory surgery and identify the factors affecting it.
METHODS: A total of 1,050 ASA I and II children aged 1-12 years, scheduled for day care surgery were enrolled. Parents of these children were given a questionnaire with specific questions like fasting instructions, source of instructions, actual fasting times and reasons for not following instructions.
RESULTS: Only 90 (8.5%) parents followed fasting instructions as advised. Of the 960 non-compliant patients, 31 (2.9) inadequately fasted while 929 (88.4%) fasted more than advised. While only 5.2% mentioned aspiration, 25% cited vomiting as the reason for fasting. Younger parents (OR = 0.853, 95% CI-0.796 to 0.915), fasting instructions in writing (OR = 10.808, 95% CI-1.459 to 80.059) and separate instruction for solids and liquids (OR = 6.016, 95% CI- 3.663 to 9.883) were found to affect compliance with fasting instructions.
CONCLUSION: To avoid risks of prolonged or inadequate fasting in day care surgical patients, good coordination between the anaesthetist and the surgeon and an updated knowledge about the preoperative fasting instructions among the health-care providers is essential. Separate written fasting instructions for liquids and solids should be given to the parents according to their order in the operating list to ensure better compliance with fasting instructions. Copyright:

INTRODUCTION

Regurgitation and aspiration of gastric contents is a potential hazard in patients undergoing general anaesthesia.[12] Fasting guidelines of 6 hr for solids, 4 hr for breast milk and 2 hr for clear liquids have been recommended for paediatric patients undergoing elective surgery to minimise the risk of regurgitation during induction of anaesthesia.[34] Owing to the detrimental metabolic and behavioural effects of prolonged fasting observed in small children, there has been recent literature on minimising the fasting time to one hour for clear fluids.[5]

It has been observed that some parents fail to comply with these instructions. Inadequate understanding of fasting instructions or the necessity for fasting, pressure to feed a hungry and crying child, wilful distortion of facts to prevent cancellation of the surgical procedure, and conflicting instructions given by more than one person or source may be some of the reasons for non-compliance.[6]

Although, there are a few studies in adult patients which assess patients' understanding and compliance with fasting instructions, little work has been done to ascertain parental understanding and identify the factors that can affect adherence to fasting instructions in children.[678] In the present study, we planned to assess parents' perception and compliance with fasting instructions in children undergoing elective surgery on day care basis as the primary objective. The secondary objective was to determine whether the source of information, educational level of parents or any other factor influences the perception and compliance.

METHODS

Patients called for elective surgery on day care basis at the Paediatric surgical wing of a tertiary care hospital in North India were recruited after obtaining ethical approval from the Institutional Ethical Committee (9605/PG-2Trg/2013/13402 dated October 7, 2014 under Chairmanship of Prof LK Dhaliwal). The trial was registered with the US National Library of Medicine (www.clinicaltrials.org identifier No. NCT03606564). Consecutive parents/legal guardians of children aged 1 to 12 years of American Society of Anesthesiologists (ASA) I and II category were asked to complete the questionnaire before taking the patient to the operating theatre (OT). Recruitment took place between October 2014 and January 2016. Children with complex nutritional requirements, e.g. feeding via gastrostomy tube, non-consenting parents or parents who could not understand the questionnaire were excluded from the study. The study was carried out in accordance with the principles of the Declaration of Helsinki.

A 13-part questionnaire was approved by the Institutional Ethical Committee. The questionnaire was prepared in English and translated into two regional languages - Hindi and Punjabi (Supplementary file). The questionnaire was given to the parents by one of the authors after proper introduction and explanation. Parents were allowed to complete the questionnaire in private and return it to the investigator. All the parents were assured that their responses would be kept confidential.

Data was analysed using SPSS version 22.0 (SPSS Inc., Chicago, IL, USA) and Microsoft Excel 2010. Normality of data was checked by using Kolmogorov–Simrnov test. For normally distributed data and continuous data, mean (SD) was calculated, e.g., age, weight, etc., For data that was not normally distributed, e.g., advised/actual time for fasting/liquid, the median (IQR/Range) was calculated using descriptive statistics. Frequency/percentage/proportion was calculated using descriptive statistics for qualitative/categorical data, e.g., sex of patients/parents, history of previous surgery, ASA status, language preferred, education level, Pre Anaesthesia Clinic (PAC) attendance, fasting instructions and their recall, separate fasting instructions for solids and liquids, sources of fasting instructions, reasons for fasting, incidence of compliance with fasting instructions (same/less than/more than), etc., Wilcoxon Signed rank test was applied to compare the median duration of advised vs actual time for fasting.

Univariate analysis of factors affecting compliance was performed using Chi Square test for categorical data, e.g. previous surgery, educational background of parents, reasons given for fasting, separate instructions given for solids and liquids and instructions written or oral and independent t-test for continuous data, e.g. parents' age. The factors that had a P value less than 0.10 for compliance in univariate analysis was taken in multivariate analysis.

Multivariate analysis (backward logistic regression) was applied to find out the association (Odds Ratios with their 95% confidence intervals) between compliance of preoperative fasting instructions and its predictors. In the final model, the history of previous surgery, educational background, reasons for fasting were excluded as their P value was <0.10. A two tailed P value <0.05 was considered statistically significant with 95% confidence interval.

Owing to the observational audit design of the study, the formal sample size calculation was not deemed necessary. All the consecutive consenting parents over the study period of 1 year were enrolled for the trial.

RESULTS

A total of 1050 ASA I and II children in the age group of 1 to 12 years scheduled for day care surgery under general anaesthesia were enrolled in the study. We did not have any exclusions due to consent refusal. Consenting parents were given the questionnaire in the preferred language and were allowed to complete the questionnaire in private and return it to the investigator. A total of 1050 completed questionnaires were analysed.

The demographic characteristics of the children and their parents are given in Table 1.

Table 1

Characteristics of 1050 children and their parents

Children’s characteristics	n =1050
Age; years	4.6 (3.5)
Weight; kg	15.47 (10.1)
Gender
Male	851 (81%)
Female	199 (19%)
ASA status
ASA I	1042 (99.2%)
ASA II	8 (0.8%)
History of previous surgery
Yes	463 (44.1%)
No	587 (55.9%)
Parent’s Characteristics
Age; years	32 (3.8)
Range	(22-46)
Gender
Male	612 (58.2%)
Female	438 (41.8%)
Language preferred
Hindi	868 (82.7%)
Punjabi	177 (16.8%)
English	5 (0.004%)
Education
Primary education	243 (23.1%)
High school	609 (58%)
Graduate and postgraduate	198 (18.8%)

Data expressed as mean (SD) or number (proportion)

Among the surveyed patients, 947 (90.2%) had attended the PAC before the scheduled operative procedure. One of the parents had not received fasting instructions.

A total of 447 (42.6%) parents did not know the exact reason for fasting. Vomiting in the perioperative period was stated by 271 (25.5%) parents whereas aspiration as the reason of fasting was given by only 55 (5.2%) parents [Table 2].

Table 2

Results of the Questionnaire

	n=1050
Source of Fasting instructions*
Surgeon	751 (71.6)
Anaesthetist	291 (27.7)
Nurse	7 (0.7)
*One patient did not receive fasting instructions
Proportion of Parents receiving separate instructions for solids and liquids	385 (36.6)
Proportion of Parents receiving written instructions	917 (87.3)
Advised Time of Fasting; hr
Solid	8 (4-12)
Liquid	6 (2-12)
Actual Time of Fasting; hr
Solid	10 (2-18)
Liquid	9 (1-16)
Parent’s understanding for the reason to fast
Vomiting	271 (25.8)
Aspiration	55 (5.2)
Surgery complication	241 (23)
Anaesthesia complication	36 (3.4)
Don’t know	447 (42.6)
Proportion of Patients non - compliant with fasting instructions	960 (91.5)
Reason for Non - Compliance with fasting instructions
Reason for inadequate fasting (n=31)
Child was anxious, irritable	21 (67.7)
Fasting instructions not explained properly	6 (19.3)
Discrepancy in fasting instructions	2 (6.4)
Child later in OT list	2 (6.4)
Reason for prolonged fasting (n=929)
Inconvenient to wake up a sleeping child	832 (89.6)
No particular reason	97 (10.4)

Values are expressed as number (proportion) and fasting time in median (range)

Only 90 (8.5%) parents followed the fasting instructions as advised. Of the 960 patients (91.5%) who did not follow the fasting instructions, 31 (2.9%) patients had inadequately fasted while 929 (88.4%) were subjected to more than advised duration of fasting.

On enquiring whether they would inform the caregiver about inadequate fasting, four parents reported that they would allow water and juice during the fasting time if the child appeared too hungry and irritable to them and would not report if it could lead to cancellation of the surgery.

It was found that 929 (88.4%) parents had over fasted their children for more than the advised time. Inconvenience in waking up the sleeping child as the reason for prolonged fasting was reported by 832 parents (89.6%) whereas 97 (10.4%) did not give any particular reason.

The actual fasting time for both solids and liquids were significantly higher than the advised fasting time (P = 0.0001). The actual time of fasting was 2–18 hrs (median 10 hrs) for solids and 1–16 hrs (median 9 hrs) for liquids. We found that 216 patients starved for 12 hr for solids while 18 patients starved for 16 hrs. For liquids, 172 patients fasted for 12 hrs and 12 patients fasted for 16 hrs.

Upon logistic regression analysis, it was found that the odds of complying with fasting instructions among parents who received separate instructions for solids and liquids is 6.01 times the odds of complying when parents did not receive separate fasting instructions (OR = 6.01, CI = 95%, P = 0.00). Also, the odds of complying with fasting instructions among parents who received written instructions was 10.8 times the odds of complying when the parents did not receive written fasting instructions. (OR = 10.8, CI = 95%, P = 0.02) [Tables 3 and 4].

Table 3

Univariate analysis using logistic regression

	P	Odds ratio (OR)	95% CI of OR
			Lower	Upper
History of previous surgery	0.096	0.650	0.392	1.079
Parent age	0.000	0.853	0.796	0.915
Educational background (Reference Category-Primary Education)
High school	0.65	1.14	0.634	2.07
Graduate and post graduate	0.078	2.07	0.922	4.67
Reasons for fasting (Reference Category- “Don’t Know”)
Vomiting	0.008	0.441	0.241	0.805
Aspiration	0.945	0.966	0.362	2.578
Surgery complication	0.001	0.292	0.137	0.624
Anaesthesia complication	0.156	0.335	0.074	1.518
Separate instructions for solids and liquids	0.000	6.016	3.663	9.883
Instructions written or oral	0.020	10.808	1.459	80.059

Composite outcome- compliance with fasting instructions

Table 4

Multivariate logistic regression analysis

	Odd’s ratio	95% CI of OR		P
		Lower	Upper
Parent age	0.853	0.796	0.915	<0.001
Separate instructions for solids and liquids	6.016	3.663	9.883	<0.001
Instructions written or oral	10.808	1.459	80.059	0.020

Composite outcome- compliance with fasting instructions

DISCUSSION

The results of the present study showed an increase in the preoperative fasting duration despite receiving fasting instructions. Regression analysis identified lower parental age, separate instructions for solids and liquids and instructions in written form as factors associated with better compliance with fasting instructions.

We found that 216 patients starved for 12 hr and 18 patients for 16 hrs for solids, while 172 patients fasted for 12 hrs and 12 patients fasted for 16 hrs for clear fluids. The significant prolongation of fasting times seen in the present study is in accordance with the previous literature documenting actual fasting times of 6–7 hours for liquids and even extending to 15 hours at times.[910111213] Prolonged fasting can not only be uncomfortable to the child, but lead to hypoglycaemia, hypovolaemia and may have a negative impact on parental satisfaction.[1415] Parental noncompliance with preoperative fasting guidelines may be caused by lack of understanding about the fasting instructions among the caregivers or incorrect orders of medical staff.[16]

Although 90.2% of patients had attended the PAC, only 27.7% received instructions from the anaesthetist. Among the remaining 72.3%, the anaesthetists left the instructions to be written by the surgeon according to the order of the patients in the OT list as they were unaware of the order of patients on the list themselves. 71.6% of the parents received fasting instructions from the surgeon who wanted to keep scope for alteration in the operative schedule on the day of surgery, therefore gave longer NPO instructions irrespective of the OT list order. Another possibility could be that many of the surgeons were not aware of the recent fasting guidelines which resulted in incorrect preoperative orders.

The guidelines recommend a fasting regime of 6 hrs for solids, 4 hrs for breast milk, and 2 hrs for clear liquids.[34] Recently, there has been a consensus statement to allow clear fluids up to one hour before elective surgery unless contraindicated.[5] The primary reason for modifying the traditional NPO after midnight regime was to decrease patient discomfort while allowing sufficient time for gastric emptying. This current concept of one-hour clear fluid rule can significantly improve the adherence to the preoperative fasting protocols as it allows for a drink on arrival and takes away the need to excessively fast for fluids even when the OT list order is not known. As the study was contemplated before this consensus statement, 2 hours of fasting was advised for liquids.

We witnessed a mere 2.9% of patients who had inadequately fasted compared to 13% as reported previously.[6] In our study, four parents thought that they could give liquids during the fasting time. The alarming fact was that these parents revealed that they would deliberately hide the fasting status from the anaesthetist if it amounted to cancellation of the surgical procedure. Similar views were expressed by adult patients in a study conducted by Walker et al.[7]

In our study, the incorrect orders placed by the medical staff itself was the reason for the inappropriate fasting as all the parents could recall the fasting instructions on the day of surgery. Arun et al.[16] reported incorrect fasting instructions by the nursing staff as the major reason for prolonged preoperative fasting in children. To avoid risks of prolonged or inadequate fasting in day care surgical patients', good coordination between the anaesthetist and the surgeon and an updated knowledge about the preoperative fasting instructions among the health-care providers is essential.

After adjusting for confounding variables, parents of younger age group, fasting instructions in writing and separate instruction for solids and liquids were found to positively affect compliance with fasting instructions. It appears that parents of younger age group, between 24 and 30 years try to follow the caregiver's advice more diligently. This could be attributed to the increased concern among the younger parents who either had younger children or came with their first child. Another possible reason could be the educational levels of the parents; however, in the present trial, we did not find any correlation with the education status and compliance with the fasting instructions. Any instruction in writing and given in a specific manner is more likely to be followed than verbal communication.

In our study, in the free text comment section, 11.6% parents complained that the fasting time was too long for both solids and liquids, which has been pointed out in previous studies as well.[6]

We tried to reduce the selection bias by including all consenting parents attending day care surgeries on the day the survey was carried out and by the fact that the survey was carried out on different days of the week.

There are some limitations of our study. As with any survey, the quality of the results depends upon the individual completing the questionnaire; in particular, their understanding of the questions and motivation to provide accurate answers. Another limitation of our study was that we noted the duration of fasting from the time the child had last meal and the time when the child reported for surgery. However, the actual duration of fasting would be much longer as it also depends on the order of the child in the OT list. Finally, we did not compare the difference in compliance with NPO orders among different providers (anaesthetist, surgeon etc) which could have provided insight about compliance with fasting orders.

CONCLUSION

Our study further ascertains the fact that majority of the children are fasted for longer than the advised time. Separate written fasting instructions for liquids and solids should be given to the parents according to their order in the operating list to ensure better compliance with fasting instructions.

Ethical approval

The study was ethically approved by the Institutional Ethics Committee (9605/PG-2Trg/2013/13402) on October 7, 2014 under Chairmanship of Prof LK Dhaliwal.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form the patients have given their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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