Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy
Observational Outcomes in Paediatric Patients Who Receive Preoperative Carbohydrate Loading for Adenoidectomy and Tonsillectomy, a Randomised Control Trial
1 other identifier
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Sep 2018
Typical duration for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2018
CompletedFirst Posted
Study publicly available on registry
August 20, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedAugust 21, 2018
August 1, 2018
1.4 years
July 11, 2018
August 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative Pain Score
Visual analogue scale (0-5)
day 1 postoperatively
Secondary Outcomes (3)
Patient and parent satisfaction
Day 1 postoperatively
Quality of sleep
Day 1 post operative
Postoperative Nausea and Vomiting
4 hours postoperatively
Study Arms (2)
Carbohydrate loading
ACTIVE COMPARATORPatients to receive an oral preoperative carbohydrate drink
No Carbohydrate loading
NO INTERVENTIONCurrent standard of care
Interventions
Children randomised to this group will receive a preoperative carbohydrate drink 90-120mins prior to surgery
Eligibility Criteria
You may qualify if:
- Undergoing Tonsillectomy and/or adenoidectomy
- consented to undertake preop carbohydrate drink and follow up procedures
You may not qualify if:
- Increased risk of aspiration or unable to swallow liquids
- outside age range
- non-consent to undertake treatment or follow up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jessica Graylead
Study Sites (1)
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator Jessica Gray
Study Record Dates
First Submitted
July 11, 2018
First Posted
August 20, 2018
Study Start
September 1, 2018
Primary Completion
February 1, 2020
Study Completion
June 1, 2020
Last Updated
August 21, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share