Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03639012
• Other study ID #: Paeds ERAS for T&A
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2018
• Est. completion date: June 2020

Study information

• Verified date: August 2018
• Source: IWK Health Centre
• Contact: Jessica A Gray, MBBS, M.Med
• Phone: 9024733721
• Email: jessica.gray[@]iwk.nshealth.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Complications
• Postoperative Nausea
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Satisfaction
• Sleep

Intervention

Dietary Supplement:
• Carbohydrate drink
Children randomised to this group will receive a preoperative carbohydrate drink 90-120mins prior to surgery

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Jessica Gray

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain Score	Visual analogue scale (0-5)	day 1 postoperatively
Secondary	Patient and parent satisfaction	Questionnaire: regarding how satisfied parents/ patients were with the treatment (satisfied or unsatisfied)	Day 1 postoperatively
Secondary	Quality of sleep	Questionnaire: (scale Child slept very well, average night sleep, poor nights sleep)	Day 1 post operative
Secondary	Postoperative Nausea and Vomiting	Questionnaire: vomiting, felt very nauseated, some nausea, none	4 hours postoperatively