Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
It's unclear if the application of topical lidocaine prior to laser follicle ablation is effective in reducing discomfort from the procedure. This study will use a doubly blinded case-control model to evaluate pain scores after the procedure comparing topical lidocaine to placebo.
Patients presenting to a dedicated Pilonidal Care Clinic who have at least 2 future laser follicle ablations planned will be queried to determine their interest in participating in the study. Patients will be randomized to topical lidocaine or placebo, which will be applied for 30 minutes prior to the laser procedure, before which it will be removed. Laser technicians will be unaware of which cream the patient received and will record a post-procedure Likert pain score, from 0 to 10.
Patients will return in 6 to 8 weeks at which time they will crossover to the other group. Patients who received lidocaine cream will receive placebo and patients who received placebo will receive lidocaine cream. Cream removal and laser follicle ablation, with post-procedure pain score recording, will be conducted as during the first visit.
Twenty patients will be recruited and each patient will act as their own control.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Sham cream placed and then removed prior to laser follicle ablation. |
|
| Active agent | Active Comparator | Topical lidocaine cream placed and then removed prior to laser follicle ablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical lidocaine | Drug | Topical lidocaine cream prior to laser follicle ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain related to laser follicle ablation | Patient description on a Likert scale from 0 to 10 of the discomfort associated with the procedure. | 5 minutes |
Not provided
Not provided
Inclusion Criteria: undergoing laser follicle ablation for pilonidal disease and expected to need at least 2 more treatments -
Exclusion Criteria: Unwilling to consent, not expected to need at least 2 more laser follicle ablations, not a candidate for laser
-
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ashley P Stoeckel, MD | Boston Children's | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital at Waltham | Waltham | Massachusetts | 02453 | United States |
Protocol details and anonymized patient data will be shared
90 days after study completion, and for 1 year
Investigator approval
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Placebo versus agent crossover per patient
Not provided
Not provided
Cream will be applied by a clinician not involved in the laser procedure and will be removed prior to the procedure. Laser technicians will assess patient pain and will be blinded, as will the patient, to the study arm.
| Sham cream | Drug | Placebo cream without lidocaine will be placed and removed before laser. |
|
| Aniline Compounds |
| D000588 | Amines |