Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy

NCT ID: NCT03639012

Last Updated: 2018-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2020-06-30

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.

Conditions

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Postoperative Pain Postoperative Nausea Satisfaction Sleep Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised control trial into 1 of 2 groups
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Carbohydrate loading

Patients to receive an oral preoperative carbohydrate drink

Group Type ACTIVE_COMPARATOR

Carbohydrate drink

Intervention Type DIETARY_SUPPLEMENT

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

No Carbohydrate loading

Current standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Carbohydrate drink

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

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jessica Gray

OTHER

Sponsor Role lead

Responsible Party

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Jessica Gray

Principal Investigator Jessica Gray

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

Central Contacts

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Jessica A Gray, MBBS, M.Med

Role: CONTACT

9024733721 ext. 3721

Ashley Zahavich

Role: CONTACT

9024733015 ext. 3015

Facility Contacts

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Jessica A Gray, MBBS

Role: primary

9024733721 ext. 3721

Ashley Zahavich

Role: backup

9024733015

Other Identifiers

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Paeds ERAS for T&A

Identifier Type: -

Identifier Source: org_study_id

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