Postoperative Pain Clinical Trial
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:
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04633850 -
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
|
||
Recruiting |
NCT03181620 -
Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation
|
N/A | |
Completed |
NCT04579354 -
Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia
|
N/A | |
Recruiting |
NCT06007378 -
Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery
|
N/A | |
Recruiting |
NCT05943015 -
Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks
|
N/A | |
Completed |
NCT04544228 -
Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy
|
N/A | |
Completed |
NCT03678168 -
A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries
|
N/A | |
Completed |
NCT03286543 -
Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System
|
N/A | |
Completed |
NCT03663478 -
Continuous TQL Block for Elective Cesarean Section
|
Phase 4 | |
Completed |
NCT04176822 -
Designing Animated Movie for Preoperative Period
|
N/A | |
Completed |
NCT05170477 -
Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment
|
N/A | |
Not yet recruiting |
NCT04561856 -
Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone
|
Phase 4 | |
Completed |
NCT06425601 -
A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy
|
N/A | |
Completed |
NCT03612947 -
TAP Block in Laparoscopic Cholecystectomy.
|
Phase 2 | |
Completed |
NCT05974501 -
Pre vs Post Block in Total Knee Arthroplasty (TKA)
|
Phase 4 | |
Completed |
NCT05995912 -
Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain
|
Phase 2 | |
Completed |
NCT04571515 -
Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
|
Phase 2 | |
Active, not recruiting |
NCT04190355 -
The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain
|
N/A | |
Recruiting |
NCT05145153 -
Incidence of Chronic Pain After Thoracic Surgery
|
||
Recruiting |
NCT03697278 -
Monitoring Postoperative Patient-controlled Analgesia (PCA)
|
N/A |