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Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy

J

Jessica Gray

Status

Unknown

Conditions

Postoperative Complications
Postoperative Pain
Satisfaction
Postoperative Nausea
Sleep

Treatments

Dietary Supplement: Carbohydrate drink

Study type

Interventional

Funder types

Other

Identifiers

NCT03639012
Paeds ERAS for T&A

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

3 to 10 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Carbohydrate loading
Active Comparator group
Description:
Patients to receive an oral preoperative carbohydrate drink
Treatment:
Dietary Supplement: Carbohydrate drink
No Carbohydrate loading
No Intervention group
Description:
Current standard of care

Trial contacts and locations

1

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Central trial contact

Ashley Zahavich; Jessica A Gray, MBBS, M.Med

Data sourced from clinicaltrials.gov

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