Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2019-11-01
2020-07-01
Brief Summary
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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.
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Detailed Description
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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.
Research participants:
100 children undergoing tonsillectomy at the Clinic for Otorhinolaryngology and Head and Neck Surgery at the Clinical Hospital Center "Sisters of Mercy" The study was designed as a prospective, randomized, parallel-group, unmasked, and longitudinal study enrolling 100 children undergoing tonsillectomy. 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.
The study will be conducted on children who have tonsillectomy at the Clinic for Otorhinolaryngology and Head and Neck Surgery in the period 12/1/2019 - 6/30/2020, and will include a total of 100 children. Parents will also participate in the research and data collection, in addition to the Clinic doctors involved in this research.
A random coin toss (binary coin-toss method) will determine which child enters the group of children who consume ice cream and which does not.
Data will be collected prospectively at each regular check-up after surgery. The data sought is a subjective feeling of pain, consumption of analgesics in milligrams depending on the type of analgesics, and the postoperative day when the diet returned to normal, preoperative conditions.
There are no risks of participating in the research.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with post-tonsillectomy ice cream
Pediatric patients undergoing tonsillectomy and receiving 2 daily ice creams for 2 weeks after surgery. Standard analgesic therapy available.
2 daily standard doses of vanilla-chocolate ice cream (cryotherapy)
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.
Patients without post-tonsillectomy ice cream
Pediatric patients undergoing tonsillectomy, not receiving any ice cream for 2 weeks after surgery. Standard analgesic therapy available.
2 daily standard doses of vanilla-chocolate ice cream (cryotherapy)
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.
Interventions
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2 daily standard doses of vanilla-chocolate ice cream (cryotherapy)
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.
Eligibility Criteria
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Inclusion Criteria
* sufficient age and dietary status), undergoing tonsillectomy
* informed consent from parents
Exclusion Criteria
* incomplete follow-up
* invalid informed consent
3 Years
18 Years
ALL
No
Sponsors
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University Hospital Sestre Milosrdnice
OTHER
Responsible Party
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Andro Košec, MD, PhD
Consultant Otorhinolaryngologist and Head and Neck Surgeon
Principal Investigators
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Goran Geber, MD, PhD
Role: STUDY_CHAIR
Department of Otorhinolaryngology and Head and Neck Surgery
Locations
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University Hospital Center Sestre milosrdnice
Zagreb, , Croatia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EP-SLA01
Identifier Type: -
Identifier Source: org_study_id
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