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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03606564
Other study ID # 9605/PG-2Trg/2013/13402
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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