Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Pain, Postoperative Nausea, Satisfaction, Sleep, Postoperative Complications

Intervention / Treatment
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* Dietary Supplement: Carbohydrate drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised control trial into 1 of 2 groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carbohydrate loading<br>Patients to receive an oral preoperative carbohydrate drink | Dietary Supplement: Carbohydrate drink<br>* Children randomised to this group will receive a preoperative carbohydrate drink 90-120mins prior to surgery<br>|
| No Intervention: No Carbohydrate loading<br>Current standard of care | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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