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Does Ice Cream Help With Post-tonsillectomy Pain

Impact of Ice Cream Consumption on Postoperative Rrecovery After Tonsillectomy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04164511
Enrollment
100
Registered
2019-11-15
Start date
2019-11-01
Completion date
2020-07-01
Last updated
2019-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryotherapy Effect, Postoperative Pain, Tonsillitis

Keywords

pediatric, tonsillectomy, ice cream, cryotherapy, postoperative pain

Brief summary

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.

Detailed description

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. Also, this research represents the first recorded attempt in the literature to test the myth of the association between tonsillectomy and ice cream in children in a prospective nonrandomized study with parallel intervention groups. 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.

Interventions

DIETARY_SUPPLEMENT2 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.

Sponsors

University Hospital Sestre Milosrdnice
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* pediatric patients able to consume ice cream * sufficient age and dietary status), undergoing tonsillectomy * informed consent from parents

Exclusion criteria

* failure to record data * incomplete follow-up * invalid informed consent

Design outcomes

Primary

MeasureTime frameDescription
Level of post-tonsillectomy pain within first 2 postoperative weeks: VAS scale14 daysLevel of post-tonsillectomy pain within first 2 postoperative weeks assessed by VAS scale

Secondary

MeasureTime frameDescription
Amount of post-tonsillectomy analgesics consumed within first 2 postoperative weeks14 daysAmount of post-tonsillectomy analgesics consumed within first 2 postoperative weeks recorded daily by type and amount (gram or miligram total)

Countries

Croatia

Contacts

Primary ContactAndro Košec, MD, PhD
andro.kosec@yahoo.com+385989817156
Backup ContactFilip Matovinović, MD
filip.matovinovic@gmail.com+385989817156

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026