Parents Perception and Compliance With Pre Operative Fasting Instructions in Paediatric Patients

Fasting Clinical Trial

Official title:

Parent's Perception and Compliance With Pre-operative Fasting Instructions in Paediatric Patients Undergoing Day Care Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606564
• Other study ID #: 9605/PG-2Trg/2013/13402
• Status: Completed
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2018
• Source: Postgraduate Institute of Medical Education and Research, Chandigarh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1050
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasting

Intervention

Other:
• study of fasting time among pediatric patients undergoing day care surgery
parents of children undergoing day care surgery were given a questionnaire to be filled containing questions regarding time of fasting that was instructed and

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education and Research,	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research, Chandigarh

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median duration of fasting	Median time of pre operative fasting as advised by anaesthesiologist/surgeon/nurse in the Pre Anaesthesia Clinic was compared with the Median duration of fasting of the patient just before surgery.	1.5 years
Primary	Percentage of parents who followed the preoperative fasting instructions	Percentage of parents who adhered to advised fasting time was compared with percentage of parents who fasted their children more than or less than what was advised.	1.5 years
Secondary	Percentage of parents who attended Pre Anaesthesia Clinic		1.5 years
Secondary	Percentage of parents who could recall fasting instructions that were provided in Pre Anaesthesia Clinic		1.5 years
Secondary	Percentage of parents who could tell if they were provided separate fasting instructions for solids and liquid foods		1.5 years
Secondary	Percentage of parents who could recall if fasting instructions were verbal or written orders		1.5 years
Secondary	Percentage of parents who received fasting instructions from anyone other than the anaesthetist		1.5 years
Secondary	Percentage of parents who understood the actual reason to fast before surgery		1.5 years
Secondary	Percentage of patients who were not adequately fasted.		1.5 years
Secondary	Percentage of parents who complained about fasting time being too long for their children		1.5 years