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Trial record 56 of 303 for:    Recruiting, Not yet recruiting, Available Studies | Pediatrics

Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy

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ClinicalTrials.gov Identifier: NCT03639012
Recruitment Status : Not yet recruiting
First Posted : August 20, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Jessica Gray, IWK Health Centre

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised 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
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Postoperative Pain Score [ Time Frame: day 1 postoperatively ]
    Visual analogue scale (0-5)


Secondary Outcome Measures :
  1. Patient and parent satisfaction [ Time Frame: Day 1 postoperatively ]
    Questionnaire: regarding how satisfied parents/ patients were with the treatment (satisfied or unsatisfied)

  2. Quality of sleep [ Time Frame: Day 1 post operative ]
    Questionnaire: (scale Child slept very well, average night sleep, poor nights sleep)

  3. Postoperative Nausea and Vomiting [ Time Frame: 4 hours postoperatively ]
    Questionnaire: vomiting, felt very nauseated, some nausea, none



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639012


Contacts
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Contact: Jessica A Gray, MBBS, M.Med 9024733721 ext 3721 jessica.gray@iwk.nshealth.ca
Contact: Ashley Zahavich 9024733015 ext 3015 ashley.zahavich@nshealth.ca

Locations
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Canada, Nova Scotia
IWK Health Centre Not yet recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Jessica A Gray, MBBS    9024733721 ext 3721    jessica.gray@iwk.nshealth.ca   
Contact: Ashley Zahavich    9024733015    ashley.zahavich@nshealth.ca   
Sponsors and Collaborators
Jessica Gray

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Responsible Party: Jessica Gray, Principal Investigator Jessica Gray, IWK Health Centre
ClinicalTrials.gov Identifier: NCT03639012     History of Changes
Other Study ID Numbers: Paeds ERAS for T&A
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Postoperative Nausea and Vomiting
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Nausea
Signs and Symptoms, Digestive
Vomiting