Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy

Sponsor

Jessica Gray (Other)

Overall Status

Unknown status

CT.gov ID

NCT03639012

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Postoperative Nausea Satisfaction Sleep Postoperative Complications	Dietary Supplement: Carbohydrate drink	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised control trial into 1 of 2 groupsRandomised control trial into 1 of 2 groups

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Carbohydrate loading

Patients to receive an oral preoperative carbohydrate drink

Dietary Supplement: Carbohydrate drink

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

No Intervention: No Carbohydrate loading

Current standard of care

Outcome Measures

Primary Outcome Measures

Postoperative Pain Score [day 1 postoperatively]
Visual analogue scale (0-5)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IWK Health Centre	Halifax	Nova Scotia	Canada	B3K 6R8

Sponsors and Collaborators

Jessica Gray

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jessica Gray, Principal Investigator Jessica Gray, IWK Health Centre

ClinicalTrials.gov Identifier:

NCT03639012

Other Study ID Numbers:

Paeds ERAS for T&A

First Posted:

Aug 20, 2018

Last Update Posted:

Aug 21, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Postoperative Complications

Postoperative Nausea and Vomiting

Study Results

No Results Posted as of Aug 21, 2018