Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy

Not Applicable

• Conditions: Satisfaction; Postoperative Complications; Postoperative Pain; Postoperative Nausea; Sleep

• Registration Number: NCT03639012
• Lead Sponsor: Jessica Gray

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.

Study Timeline

• Study First Submitted: 2018-07-11
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-20
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-21
• Study Start: 2018-09
• Primary Completion: 2020-02
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative Pain Score	day 1 postoperatively	Visual analogue scale (0-5)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada