TonsillitisNCT04164511
Does Ice Cream Help With Post-tonsillectomy Pain
An observational study of Tonsillitis and Postoperative Pain, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Tonsillitis, Postoperative Pain, Cryotherapy Effect
- What is being tested?
- 2 daily standard doses of vanilla-chocolate ice cream (cryotherapy)
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Nov 2019to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients undergoing tonsillectomy in a tertiary referral center.
Who may be able to join
- pediatric patients able to consume ice cream
- sufficient age and dietary status), undergoing tonsillectomy
- informed consent from parents
Who cannot join
- failure to record data
- incomplete follow-up
- invalid informed consent
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Center Sestre milosrdnice
Zagreb, 10000
Andro Košec, MD, PhD, +385989817156, andro.kosec@yahoo.com
Filip Matovinović, MD, +385989817156, filip.matovinovic@gmail.com
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Tonsillitis, Postoperative Pain, Cryotherapy Effect
- Being tested
- 2 daily standard doses of vanilla-chocolate ice cream (cryotherapy)
- Keywords
- pediatric, tonsillectomy, ice cream, cryotherapy, postoperative pain
- Medical subject headings
- Tonsillitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 daily standard doses of vanilla-chocolate ice cream (cryotherapy)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: 2 daily standard doses of vanilla-chocolate ice cream (cryotherapy) | |
| Patients without post-tonsillectomy ice cream | Pediatric patients undergoing tonsillectomy, not receiving any ice cream for 2 weeks after surgery. Standard analgesic therapy available. Receives: Dietary Supplement: 2 daily standard doses of vanilla-chocolate ice cream (cryotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (1)
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)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Nov 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andro Košec, MD, PhD, University Hospital Sestre Milosrdnice
- Investigators
- Goran Geber, MD, PhD, Study chair, Department of Otorhinolaryngology and Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164511
- Sponsor's protocol ID
- EP-SLA01
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ice Cream Consumption on Postoperative Rrecovery After Tonsillectomy
- ClinicalTrials.gov ID
- NCT04164511
- Acronym / sponsor ID
- EP-SLA01
- Conditions
- Tonsillitis, Postoperative Pain, Cryotherapy Effect
- Keywords
- pediatric, tonsillectomy, ice cream, cryotherapy, postoperative pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital Sestre MilosrdniceUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with post-tonsillectomy ice cream | – | Dietary Supplement: 2 daily standard doses of vanilla-chocolate ice cream (cryotherapy)Pediatric patients undergoing tonsillectomy and receiving 2 daily ice creams for 2 weeks after surgery. Standard analgesic therapy available. |
| Patients without post-tonsillectomy ice cream | – | Dietary Supplement: 2 daily standard doses of vanilla-chocolate ice cream (cryotherapy)Pediatric patients undergoing tonsillectomy, not receiving any ice cream for 2 weeks after surgery. Standard analgesic therapy available. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients undergoing tonsillectomy in a tertiary referral center.
Key inclusion criteria (3 listed)
- pediatric patients able to consume ice cream
- sufficient age and dietary status), undergoing tonsillectomy
- informed consent from parents
Key exclusion criteria (3 listed)
- failure to record data
- incomplete follow-up
- invalid informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Patients with post-tonsillectomy ice cream, Patients without post-tonsillectomy ice cream |
Primary outcome
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
1 secondary outcome
Amount of post-tonsillectomy analgesics consumed within first 2 postoperative weeks
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goran Geber, MD, PhD study chair
Department of Otorhinolaryngology and Head and Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tonsillitis and Postoperative Pain, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andro Košec, MD, PhD (+385989817156, andro.kosec@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of post-tonsillectomy pain within first 2 postoperative weeks: VAS scale (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.