Clinical trial NCT04164511: Does Ice Cream Help With Post-tonsillectomy Pain
Official title: Impact of Ice Cream Consumption on Postoperative Rrecovery After Tonsillectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tonsillitis
Postoperative Pain
Cryotherapy Effect
Keywords: pediatric
tonsillectomy
ice cream
cryotherapy
postoperative pain
Lead sponsor: University Hospital Sestre Milosrdnice
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients undergoing tonsillectomy in a tertiary referral center.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of post-tonsillectomy pain within first 2 postoperative weeks: VAS scale
timeFrame: 14 days
Secondary outcomes:
measure: Amount of post-tonsillectomy analgesics consumed within first 2 postoperative weeks
timeFrame: 14 days
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Center Sestre milosrdnice
Study officials:
affiliation: Department of Otorhinolaryngology and Head and Neck Surgery
name: Goran Geber, MD, PhD
role: STUDY_CHAIR
References: