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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03639012
Enrollment
150
Registered
2018-08-20
Start date
2018-09-30
Completion date
2020-06-30
Last updated
2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Postoperative Nausea, Satisfaction, Sleep, Postoperative Complications

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.

Interventions

DIETARY_SUPPLEMENTCarbohydrate drink

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

Sponsors

Jessica Gray
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Randomised control trial into 1 of 2 groups

Eligibility

Sex/Gender
ALL
Age
3 Years to 10 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain Scoreday 1 postoperativelyVisual analogue scale (0-5)

Secondary

MeasureTime frameDescription
Patient and parent satisfactionDay 1 postoperativelyQuestionnaire: regarding how satisfied parents/ patients were with the treatment (satisfied or unsatisfied)
Quality of sleepDay 1 post operativeQuestionnaire: (scale Child slept very well, average night sleep, poor nights sleep)
Postoperative Nausea and Vomiting4 hours postoperativelyQuestionnaire: vomiting, felt very nauseated, some nausea, none

Countries

Canada

Contacts

Primary ContactJessica A Gray, MBBS, M.Med
jessica.gray@iwk.nshealth.ca9024733721
Backup ContactAshley Zahavich
ashley.zahavich@nshealth.ca9024733015

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026