Using Dexpanthenol Cream to Prevent Lip Corner Cracks in Children After Tonsil/Adenoid Surgery (PrevAC-PedAT)

Gaziosmanpasa Research and Education Hospital

Status: Completed

Conditions: Postoperative Complications; Cheilitis, Angular; Adenotonsillar Hypertrophy

Treatments: Drug: Dexpanthenol 5 % Topical Ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT07002632

309 Anguler Cehilitis

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 3 to 15 years old

Volunteers: No Healthy Volunteers

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 4 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

Dexpanthenol group

Experimental group

Description:

Participants in this arm received a single application of 5% dexpanthenol cream (water-in-oil emulsion) to both oral commissures. The cream was applied immediately before mouth gag insertion at the start of the adenotonsillectomy procedure.

Treatment:

Drug: Dexpanthenol 5 % Topical Ointment

Control group

No Intervention group

Description:

Participants in this arm received no topical cream or moisturizer on the oral commissures before or during the adenotonsillectomy procedure.