Does Ice Cream Help With Post-tonsillectomy Pain

NCT04164511 | Unknown

• 1 other identifier: EP-SLA01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsillitis; Postoperative Pain; Cryotherapy Effect

Keywords

pediatric; tonsillectomy; ice cream; cryotherapy; postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Amount of post-tonsillectomy analgesics consumed within first 2 postoperative weeks

  14 days

Study Arms (2)

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.

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.

Dietary Supplement: 2 daily standard doses of vanilla-chocolate ice cream (cryotherapy)

Interventions

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.

Patients with post-tonsillectomy ice cream; Patients without post-tonsillectomy ice cream

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients undergoing tonsillectomy in a tertiary referral center.

You may qualify if:

• pediatric patients able to consume ice cream
• sufficient age and dietary status), undergoing tonsillectomy
• informed consent from parents

You may not qualify if:

• failure to record data
• incomplete follow-up
• invalid informed consent

Sponsors & Collaborators

• University Hospital Sestre Milosrdnice: lead

Study Sites (1)

University Hospital Center Sestre milosrdnice

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Tonsillitis; Pain, Postoperative

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Goran Geber, MD, PhD

  Department of Otorhinolaryngology and Head and Neck Surgery

  STUDY CHAIR

Central Study Contacts

Andro Košec, MD, PhD

CONTACT

+385989817156; andro.kosec@yahoo.com

Filip Matovinović, MD

CONTACT

+385989817156; filip.matovinovic@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Otorhinolaryngologist and Head and Neck Surgeon

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 15, 2019
• Study Start: November 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: July 1, 2020
• Last Updated: November 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)