- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04164511
Does Ice Cream Help With Post-tonsillectomy Pain
Impact of Ice Cream Consumption on Postoperative Rrecovery After Tonsillectomy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Filip Matovinović, MD
- Phone Number: +385989817156
- Email: filip.matovinovic@gmail.com
Study Locations
-
-
-
Zagreb, Croatia, 10000
- Recruiting
- University Hospital Center Sestre milosrdnice
-
Contact:
- Filip Matovinović, MD
- Phone Number: +385989817156
- Email: filip.matovinovic@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of post-tonsillectomy pain within first 2 postoperative weeks: VAS scale
Time Frame: 14 days
|
Level of post-tonsillectomy pain within first 2 postoperative weeks assessed by VAS scale
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of post-tonsillectomy analgesics consumed within first 2 postoperative weeks
Time Frame: 14 days
|
Amount of post-tonsillectomy analgesics consumed within first 2 postoperative weeks recorded daily by type and amount (gram or miligram total)
|
14 days
|
Collaborators and Investigators
Investigators
- Study Chair: Goran Geber, MD, PhD, Department of Otorhinolaryngology and Head and Neck Surgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EP-SLA01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States