Adenotonsillar Hypertrophy, Cheilitis, Angular, Postoperative Complications
Conditions
Keywords
Cheilitis, Angular, Tonsillectomy, Adenoidectomy, Dexpanthenol, Pain, Pediatrics
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.
Interventions
DRUGDexpanthenol 5 % Topical Ointment
Dexpanthenol is a topical agent, a derivative of pantothenic acid (a B-complex vitamin), used for its moisturizing and skin regenerative properties. The formulation studied was a 5% dexpanthenol in a water-in-oil emulsion.
Sponsors
Gaziosmanpasa Research and Education Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor, a senior surgeon responsible for evaluating postoperative angular cheilitis and pain, was blinded to the treatment group allocation of the participants.
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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 15 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Angular Cheilitis | Postoperative Day 1 and Postoperative Day 7 | Presence or absence of angular cheilitis determined by clinical examination. Angular cheilitis was defined as any inflammation, erythema, fissures, ulceration, or crusting at one or both oral commissures. Evaluations were performed by a senior surgeon blinded to treatment group allocation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score | Postoperative Day 1 and Postoperative Day 7 | Pain intensity was assessed by the parents using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 (no hurt) to 10 (hurts worst). |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Participants were recruited from the Department of Otorhinolaryngology at a single tertiary care center, Gaziosmanpasa Training and Research Hospital, in Istanbul, Turkey. The recruitment period for the study was between July 2021 and June 2024. Eligible participants were children aged 3 to 15 years who were scheduled for adenotonsillectomy and were identified during their routine preoperative clinical assessment.
Pre-assignment details
No pre-assignment events, such as a run-in or washout period, occurred in this study. Enrolled participants were directly randomized to their assigned group after meeting the eligibility criteria.
Participants by arm
| Arm | Count |
|---|---|
| Dexpanthenol Group 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.
Dexpanthenol 5 % Topical Ointment: Dexpanthenol is a topical agent, a derivative of pantothenic acid (a B-complex vitamin), used for its moisturizing and skin regenerative properties. The formulation studied was a 5% dexpanthenol in a water-in-oil emulsion. | 51 |
| Control Group Participants in this arm received no topical cream or moisturizer on the oral commissures before or during the adenotonsillectomy procedure. | 50 |
| Total | 101 |
Baseline characteristics
| Characteristic | Control Group | Dexpanthenol Group | Total |
|---|---|---|---|
| Age, Continuous | 5.96 years STANDARD_DEVIATION 2.82 | 6.65 years STANDARD_DEVIATION 2.36 | 6.31 years STANDARD_DEVIATION 2.61 |
| Mallampati Classification class 1 | 39 Participants | 43 Participants | 82 Participants |
| Mallampati Classification class 2 | 11 Participants | 8 Participants | 19 Participants |
| Mallampati Classification class 3 | 0 Participants | 0 Participants | 0 Participants |
| Mallampati Classification class 4 | 0 Participants | 0 Participants | 0 Participants |
| Mouth opener size | 7.01 centimeters STANDARD_DEVIATION 1.15 | 7.36 centimeters STANDARD_DEVIATION 0.76 | 7.18 centimeters STANDARD_DEVIATION 0.98 |
| Operation time | 38.86 minutes STANDARD_DEVIATION 18.53 | 35.10 minutes STANDARD_DEVIATION 14.39 | 36.96 minutes STANDARD_DEVIATION 16.59 |
| Pre-operative Tonsil Grade Grade 1 | 7 Participants | 8 Participants | 15 Participants |
| Pre-operative Tonsil Grade Grade 2 | 14 Participants | 14 Participants | 28 Participants |
| Pre-operative Tonsil Grade Grade 3 | 16 Participants | 18 Participants | 34 Participants |
| Pre-operative Tonsil Grade Grade 4 | 13 Participants | 11 Participants | 24 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Turkey | 50 Participants | 51 Participants | 101 Participants |
| Sex: Female, Male Female | 20 Participants | 25 Participants | 45 Participants |
| Sex: Female, Male Male | 30 Participants | 26 Participants | 56 Participants |
| Surgical Indication Obstructive sleep apnea | 13 Participants | 14 Participants | 27 Participants |
| Surgical Indication Recurrent adenotonsillitis | 6 Participants | 10 Participants | 16 Participants |
| Surgical Indication Recurrent tonsillitis + obstructive sleep apnea | 31 Participants | 27 Participants | 58 Participants |
| Vertical mouth opening length | 4.63 centimeters STANDARD_DEVIATION 0.89 | 4.48 centimeters STANDARD_DEVIATION 0.7 | 4.55 centimeters STANDARD_DEVIATION 0.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 50 |
| other Total, other adverse events | 51 / 51 | 50 / 50 |
| serious Total, serious adverse events | 0 / 51 | 0 / 50 |
Outcome results
Primary
Incidence of Angular Cheilitis
Presence or absence of angular cheilitis determined by clinical examination. Angular cheilitis was defined as any inflammation, erythema, fissures, ulceration, or crusting at one or both oral commissures. Evaluations were performed by a senior surgeon blinded to treatment group allocation.
Time frame: Postoperative Day 1 and Postoperative Day 7
Population: The analysis for this outcome measure was performed on all participants who completed the study. A total of 106 participants were initially randomized, but five were lost to follow-up. Therefore, the analysis population for this outcome consists of the 101 participants who completed the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexpanthenol Group | Incidence of Angular Cheilitis | 1st day Angular cheilitis pozitif | 5 Participants |
| Dexpanthenol Group | Incidence of Angular Cheilitis | 1st day Angular cheilitis negative | 46 Participants |
| Dexpanthenol Group | Incidence of Angular Cheilitis | 1st week Angular cheilitis pozitif | 2 Participants |
| Dexpanthenol Group | Incidence of Angular Cheilitis | 1st week Angular cheilitis negative | 49 Participants |
| Control Group | Incidence of Angular Cheilitis | 1st week Angular cheilitis negative | 45 Participants |
| Control Group | Incidence of Angular Cheilitis | 1st day Angular cheilitis pozitif | 22 Participants |
| Control Group | Incidence of Angular Cheilitis | 1st week Angular cheilitis pozitif | 5 Participants |
| Control Group | Incidence of Angular Cheilitis | 1st day Angular cheilitis negative | 28 Participants |
Secondary
Postoperative Pain Score
Pain intensity was assessed by the parents using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 (no hurt) to 10 (hurts worst).
Time frame: Postoperative Day 1 and Postoperative Day 7
Population: The analysis for this outcome measure was performed on all participants who completed the study. A total of 106 participants were initially enrolled, but five were lost to follow-up. Therefore, the analysis population for this outcome consists of the 101 participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexpanthenol Group | Postoperative Pain Score | 1st day pain score | 4.47 score on a scale | Standard Deviation 1.93 |
| Dexpanthenol Group | Postoperative Pain Score | 1st week pain score | 2.41 score on a scale | Standard Deviation 1.66 |
| Control Group | Postoperative Pain Score | 1st day pain score | 4.48 score on a scale | Standard Deviation 1.94 |
| Control Group | Postoperative Pain Score | 1st week pain score | 2.38 score on a scale | Standard Deviation 1.59 |