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

Sponsors

Lead Sponsor: Jessica Gray

Source IWK Health Centre
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.

Overall Status Not yet recruiting
Start Date September 2018
Completion Date June 2020
Primary Completion Date February 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Postoperative Pain Score day 1 postoperatively
Secondary Outcome
Measure Time Frame
Patient and parent satisfaction Day 1 postoperatively
Quality of sleep Day 1 post operative
Postoperative Nausea and Vomiting 4 hours postoperatively
Enrollment 150
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Carbohydrate drink

Description: Children randomised to this group will receive a preoperative carbohydrate drink 90-120mins prior to surgery

Arm Group Label: Carbohydrate loading

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

Gender: All

Minimum Age: 3 Years

Maximum Age: 10 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Last Name: Jessica A Gray, MBBS, M.Med

Phone: 9024733721

Phone Ext.: 3721

Email: [email protected]

Location
Facility: Contact: Contact Backup: IWK Health Centre Jessica A Gray, MBBS 9024733721 3721 [email protected]
Location Countries

Canada

Verification Date

August 2018

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: IWK Health Centre

Investigator Full Name: Jessica Gray

Investigator Title: Principal Investigator Jessica Gray

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Carbohydrate loading

Type: Active Comparator

Description: Patients to receive an oral preoperative carbohydrate drink

Label: No Carbohydrate loading

Type: No Intervention

Description: Current standard of care

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Randomised control trial into 1 of 2 groups

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov