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Does Ice Cream Help With Post-tonsillectomy Pain

NCT04164511 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-11-20

No results posted yet for this study

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.

Conditions

  • Tonsillitis
  • Postoperative Pain
  • Cryotherapy Effect

Interventions

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • University Hospital Sestre Milosrdnice

    lead OTHER

Principal Investigators

  • Goran Geber, MD, PhD · Department of Otorhinolaryngology and Head and Neck Surgery

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2020-06-30
Completion
2020-07-01

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04164511 on ClinicalTrials.gov