Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy

August 20, 2018 updated by: Jessica Gray

Observational Outcomes in Paediatric Patients Who Receive Preoperative Carbohydrate Loading for Adenoidectomy and Tonsillectomy, a Randomised Control Trial

Randomised control trial of 150 paediatric patients aged between 3-8years. One group will receive a preoperative carbohydrate oral drink and the other group will receive current standard care (no drink) prior to undergoing tonsillectomy and/or adenoidectomy.

Outcomes to be reported will be: 1) patient and parent satisfaction; 2) post operative pain score at: recover, 1 hour post op, prior to discharge home and then day 1 postoperatively; 3) PONV rates in recovery, prior to discharge home and again on Day 1 postoperatively; 4) sleep quality night after surgery.

Study Overview

Detailed Description

Children undergoing tonsillectomy and/or adenoidectomy will be consented via parents prior to the day of surgery and then randomised to 1 of 2 groups who will either receive the intervention or current standard care. Patients will be recruited from the ENT outpatient clinics in conjunction with the ENT surgeons.

Data collection will be undertaken with the aid of experience research assistants.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergoing Tonsillectomy and/or adenoidectomy
  • consented to undertake preop carbohydrate drink and follow up procedures

Exclusion Criteria:

  • Increased risk of aspiration or unable to swallow liquids
  • outside age range
  • non-consent to undertake treatment or follow up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Carbohydrate loading
Patients to receive an oral preoperative carbohydrate drink
Children randomised to this group will receive a preoperative carbohydrate drink 90-120mins prior to surgery
NO_INTERVENTION: No Carbohydrate loading
Current standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Score
Time Frame: day 1 postoperatively
Visual analogue scale (0-5)
day 1 postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient and parent satisfaction
Time Frame: Day 1 postoperatively
Questionnaire: regarding how satisfied parents/ patients were with the treatment (satisfied or unsatisfied)
Day 1 postoperatively
Quality of sleep
Time Frame: Day 1 post operative
Questionnaire: (scale Child slept very well, average night sleep, poor nights sleep)
Day 1 post operative
Postoperative Nausea and Vomiting
Time Frame: 4 hours postoperatively
Questionnaire: vomiting, felt very nauseated, some nausea, none
4 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2018

Primary Completion (ANTICIPATED)

February 1, 2020

Study Completion (ANTICIPATED)

June 1, 2020

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (ACTUAL)

August 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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