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Clinical Trials/NCT03639012
NCT03639012
Unknown
Not Applicable

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

Jessica Gray1 site in 1 country150 target enrollmentSeptember 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Jessica Gray
Enrollment
150
Locations
1
Primary Endpoint
Postoperative Pain Score
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2018
End Date
June 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jessica Gray
Responsible Party
Sponsor Investigator
Principal Investigator

Jessica Gray

Principal Investigator Jessica Gray

IWK Health Centre

Eligibility Criteria

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

Outcomes

Primary Outcomes

Postoperative Pain Score

Time Frame: day 1 postoperatively

Visual analogue scale (0-5)

Secondary Outcomes

  • Quality of sleep(Day 1 post operative)
  • Patient and parent satisfaction(Day 1 postoperatively)
  • Postoperative Nausea and Vomiting(4 hours postoperatively)

Study Sites (1)

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