- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03639012
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
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
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jessica A Gray, MBBS, M.Med
- Phone Number: 3721 9024733721
- Email: jessica.gray@iwk.nshealth.ca
Study Contact Backup
- Name: Ashley Zahavich
- Phone Number: 3015 9024733015
- Email: ashley.zahavich@nshealth.ca
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
-
Contact:
- Jessica A Gray, MBBS
- Phone Number: 3721 9024733721
- Email: jessica.gray@iwk.nshealth.ca
-
Contact:
- Ashley Zahavich
- Phone Number: 9024733015
- Email: ashley.zahavich@nshealth.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Paeds ERAS for T&A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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