Clinical trial NCT07002632: Using Dexpanthenol Cream to Prevent Lip Corner Cracks in Children After Tonsil/Adenoid Surgery
Official title: Effect of Preoperative Dexpanthenol Moisturizer on the Prevention of Angular Cheilitis After Pediatric Adenotonsillectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cheilitis, Angular
Postoperative Complications
Adenotonsillar Hypertrophy
Keywords: Cheilitis, Angular
Tonsillectomy
Adenoidectomy
Dexpanthenol
Pain
Pediatrics
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2025-06-03
Enrollment: 106
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a parallel-group, randomized, controlled trial. Participants were randomly assigned to one of two arms: an intervention group receiving preoperative dexpanthenol moisturizer or a control group receiving no preoperative topical intervention. Participants remained in their assigned group for the duration of the study.
Primary purpose: PREVENTION

Brief summary: Soreness and cracking at the corners of the mouth, a condition called angular cheilitis, can be an uncomfortable problem for children after they have surgery to remove their tonsils and adenoids. This study looks at whether applying a moisturizing cream containing dexpanthenol to the corners of the mouth right before the surgery can help prevent this from happening.

The main idea (hypothesis)i the investigators are testing is that this dexpanthenol cream will protect the skin and reduce the number of children who get these painful lip sores after their operation.

To find this out, children who are scheduled to have tonsil and/or adenoid surgery will be invited to join the study. Children (participants) will be randomly placed into one of two groups by chance. One group of children will have the dexpanthenol cream applied to their lip corners just before their surgery. The other group will not have any cream applied to their lip corners before surgery. After the surgery, investigators will check all children to see if they have developed lip corner sores and compare how many children in each group experienced this problem.

The goal of this research is to see if this simple cream application can be an easy way to help children feel more comfortable while they are recovering from their surgery.


Eligibility criteria: Inclusion Criteria:

* Age between 3 and 15 years, inclusive
* Scheduled for adenotonsillectomy (for indications such as obstructive sleep apnea and/or recurrent tonsillitis/adenotonsillitis).
* Written informed consent provided by parents or legal guardians.

Exclusion Criteria:

* Known allergy or hypersensitivity to dexpanthenol or any components of the cream.
* Presence of angular cheilitis at the time of preoperative assessment.
* Use of topical or systemic steroids or antibiotics within \[örneğin, 2 weeks\] prior to surgery that might affect oral healing.
* Participants with known systemic diseases or conditions that might impair wound healing (e.g., uncontrolled diabetes, immunosuppressive disorders).
* Known diagnosis of iron deficiency and/or vitamin B12 deficiency prior to surgery.

Primary outcomes:
measure: Incidence of Angular Cheilitis
timeFrame: Postoperative Day 1 and Postoperative Day 7
Secondary outcomes:
measure: Postoperative Pain Score
timeFrame: Postoperative Day 1 and Postoperative Day 7
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training and Research Hospital
Study officials:
affiliation: Department of ENT, University of Health Sciences, Gaziosmanpasa TREH, Istanbul, Turkey
name: ethem ilhan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: England RJ, Lau M, Ell SR. Angular cheilitis after tonsillectomy. Clin Otolaryngol Allied Sci. 1999 Aug;24(4):277-9. doi: 10.1046/j.1365-2273.1999.00255.x.