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Impact of Ice Cream Consumption on Postoperative Rrecovery After Tonsillectomy
Sponsor study identifier
observational
100
1 country
1
Study Start
November 1, 2019
Actual (reported)Primary Completion
June 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Tonsillectomy is one of the most performed procedures in childhood, which carries with it certain postoperative problems, such as the pain of the operated area. Sickness greatly impairs the quality of life in the postoperative period and further reduces food and fluid intake in children, which in turn causes prolonged recovery after surgery. The impact of cooling oropharynx in the form of ice cream consumption as a form of cryotherapy could help reduce the pain, reduce the use of oral analgesic therapy and help in faster recovery after surgery. Research goal: The aim of the study is to determine whether the consumption of ice cream, as a form of cryotherapy, influences the rate of postoperative recovery after tonsillectomy and the consumption of oral analgesics in children. The study was designed as a prospective, randomized, parallel-group, unmasked, and longitudinal study enroling 100 children undergoing tonsillectomy in a tertiary referral center. Of those children, 60 will consume the same ice cream (a combination of vanilla and chocolate as universally acceptable flavors) twice daily, morning and evening, for two weeks after surgery. 40 children will not consume ice cream during the stated period. Parents will be given a questionnaire with a validated VAS Wong-Baker FACES scale (Visual - Analogue - Scale) used by the Zagreb Pediatric Disease Clinic to be completed at home based on communication with the child and containing information on a visual-analogue subjective pain experience in children every morning after eating ice cream and the amount of analgesics the children received during the first two weeks after surgery. There will also be a record of the days when children began to consume food and drink in the same range and quality as before surgery.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2019
Actual (reported)November 12, 2019
Actual (reported)November 15, 2019
Actual (reported)June 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Level of post-tonsillectomy pain within first 2 postoperative weeks: VAS scale
Level of post-tonsillectomy pain within first 2 postoperative weeks assessed by VAS scale
14 days
Amount of post-tonsillectomy analgesics consumed within first 2 postoperative weeks
14 days
Pediatric patients undergoing tonsillectomy and receiving 2 daily ice creams for 2 weeks after surgery. Standard analgesic therapy available.
Pediatric patients undergoing tonsillectomy, not receiving any ice cream for 2 weeks after surgery. Standard analgesic therapy available.
The patients will receive 2 daily standard doses of vanilla-chocolate ice cream (cryotherapy) for 2 weeks post-op, with amount of analgesic consumption and subjective pain levels recorded on a VAS scale.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Pediatric patients undergoing tonsillectomy in a tertiary referral center.
University Hospital Center Sestre milosrdnice
Zagreb, 10000, Croatia
Goran Geber, MD, PhD
Department of Otorhinolaryngology and Head and Neck Surgery
First Submitted
November 12, 2019
First Posted
November 15, 2019
Study Start
November 1, 2019
Actual (reported)Primary Completion
June 30, 2020
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 20, 2019
Record last verified: 2019-11
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Source: ClinicalTrials.gov.
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