Back to resultsOutcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy
Primary Purpose
Postoperative Pain, Postoperative Nausea, Satisfaction
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Carbohydrate drink
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- IWK Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Carbohydrate loading
No Carbohydrate loading
Arm Description
Patients to receive an oral preoperative carbohydrate drink
Current standard of care
Outcomes
Primary Outcome Measures
Postoperative Pain Score
Visual analogue scale (0-5)
Secondary Outcome Measures
Patient and parent satisfaction
Questionnaire: regarding how satisfied parents/ patients were with the treatment (satisfied or unsatisfied)
Quality of sleep
Questionnaire: (scale Child slept very well, average night sleep, poor nights sleep)
Postoperative Nausea and Vomiting
Questionnaire: vomiting, felt very nauseated, some nausea, none
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03639012
Brief Title
Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy
Official Title
Observational Outcomes in Paediatric Patients Who Receive Preoperative Carbohydrate Loading for Adenoidectomy and Tonsillectomy, a Randomised Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jessica Gray
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Nausea, Satisfaction, Sleep, Postoperative Complications
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised control trial into 1 of 2 groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Carbohydrate loading
Arm Type
Active Comparator
Arm Description
Patients to receive an oral preoperative carbohydrate drink
Arm Title
No Carbohydrate loading
Arm Type
No Intervention
Arm Description
Current standard of care
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate drink
Intervention Description
Children randomised to this group will receive a preoperative carbohydrate drink 90-120mins prior to surgery
Primary Outcome Measure Information:
Title
Postoperative Pain Score
Description
Visual analogue scale (0-5)
Time Frame
day 1 postoperatively
Secondary Outcome Measure Information:
Title
Patient and parent satisfaction
Description
Questionnaire: regarding how satisfied parents/ patients were with the treatment (satisfied or unsatisfied)
Time Frame
Day 1 postoperatively
Title
Quality of sleep
Description
Questionnaire: (scale Child slept very well, average night sleep, poor nights sleep)
Time Frame
Day 1 post operative
Title
Postoperative Nausea and Vomiting
Description
Questionnaire: vomiting, felt very nauseated, some nausea, none
Time Frame
4 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica A Gray, MBBS, M.Med
Phone
9024733721
Ext
3721
Email
jessica.gray@iwk.nshealth.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Zahavich
Phone
9024733015
Ext
3015
Email
ashley.zahavich@nshealth.ca
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica A Gray, MBBS
Phone
9024733721
Ext
3721
Email
jessica.gray@iwk.nshealth.ca
First Name & Middle Initial & Last Name & Degree
Ashley Zahavich
Phone
9024733015
Email
ashley.zahavich@nshealth.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy
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