Does Ice Cream Help With Post-tonsillectomy Pain

Postoperative Pain Clinical Trial

Official title:

Impact of Ice Cream Consumption on Postoperative Rrecovery After Tonsillectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04164511
• Other study ID #: EP-SLA01
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: November 2019
• Source: University Hospital "Sestre Milosrdnice"
• Contact: Andro Košec, MD, PhD
• Phone: +385989817156
• Email: andro.kosec[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cryotherapy Effect
• Pain, Postoperative
• Postoperative Pain
• Tonsillitis

Intervention

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.

Locations

Country	Name	City	State
Croatia	University Hospital Center Sestre milosrdnice	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital "Sestre Milosrdnice"

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Amount of post-tonsillectomy analgesics consumed within first 2 postoperative weeks	Amount of post-tonsillectomy analgesics consumed within first 2 postoperative weeks recorded daily by type and amount (gram or miligram total)	14 days