Clinical trial NCT03606564: Parents Perception and Compliance With Pre Operative Fasting Instructions in Paediatric Patients
Official title: Parent's Perception and Compliance With Pre-operative Fasting Instructions in Paediatric Patients Undergoing Day Care Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting
Keywords: compliance
fasting guidelines
Lead sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 1050
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive children aged 1 to 12 years of ASA I and II category, scheduled to undergo elective day care surgery under general anaesthesia, were included in this prospective study

Brief summary: This study evaluates the perception and compliance with the fasting instructions given to parents of children undergoing surgery. A questionnaire was provided to the parents indicating fasting time requested and actual time of fasting.

Detailed description: American Society of Anesthesiologists (ASA) have recommended fasting guidelines of 8 hours of solids, 6 hours for formula milk, 4 hours for breast milk and 2 hours of clear liquids, for preoperative patients undergoing elective surgery. Parents of Children undergoing surgery are instructed to adhere to these guidelines. Parents might not be compliant with these instructions. They may fast their children less than or more than the recommended time.

Main aim of this study is to find out the incidence of non compliance with the fasting instructions and try to find the reasons for such non compliance.

Eligibility criteria: Inclusion Criteria:

* Children aged 1 to 12 years
* ASA I and II category
* Elective day care surgery
* General anaesthesia planned

Exclusion Criteria

* Parent's refusal to participate.
* Children with complex nutritional requirements eg. feeding via gastrostomy tube
* Parents who cannot read or understand English, Hindi or Punjabi

Primary outcomes:
measure: Median duration of fasting
timeFrame: 1.5 years
measure: Percentage of parents who followed the preoperative fasting instructions
timeFrame: 1.5 years
Secondary outcomes:
measure: Percentage of parents who attended Pre Anaesthesia Clinic
timeFrame: 1.5 years
measure: Percentage of parents who could recall fasting instructions that were provided in Pre Anaesthesia Clinic
timeFrame: 1.5 years
measure: Percentage of parents who could tell if they were provided separate fasting instructions for solids and liquid foods
timeFrame: 1.5 years
measure: Percentage of parents who could recall if fasting instructions were verbal or written orders
timeFrame: 1.5 years
measure: Percentage of parents who received fasting instructions from anyone other than the anaesthetist
timeFrame: 1.5 years
measure: Percentage of parents who understood the actual reason to fast before surgery
timeFrame: 1.5 years
measure: Percentage of patients who were not adequately fasted.
timeFrame: 1.5 years
measure: Percentage of parents who complained about fasting time being too long for their children
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research,
Study officials:
affiliation: PGIMER, chandigarh, india
name: indu bala, MD
role: PRINCIPAL_INVESTIGATOR
References: