Phase 4
N=31
Pain Outcomes Following Intralesional Corticosteroid Injections
Keloid · Alopecia Areata · Acne · Hypertrophic Scar · Epidermal Inclusion Cyst
Bottom Line
View on ClinicalTrials.gov: NCT03630198 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Pain Outcome: Visual Analog Scale — 5.4; 2.7 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Corticosteroid with lidocaine (Drug); Corticosteroid with normal saline (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Outcome: Visual Analog Scale |
0.9; 0.1; 0; 0 | — |
Summary
Corticosteroid therapy, including intralesional and topical applications, has many indications within the fields of Dermatology, Plastic Surgery, and Orthopedics. However, these injections can be quite painful, which leads many patients to discontinue treatment.
Often, the injection involves a mixture of local anesthetic and corticosteroids despite a lack of evidence that the use of lidocaine improves pain. Due to the acidic pH, the lidocaine component of the injection can actually cause a significant burning sensation during the procedure. Lidocaine does not have anti-inflammatory properties and does not treat the underlying pathology. By including another medication, lidocaine also adds cost and risk to the procedure.
The purpose of this study is to see if removing lidocaine from intralesional injections decreases the pain of injection.
Eligibility Criteria
Inclusion Criteria
- >12 years old presenting with an indication for intralesional steroid injection
Exclusion Criteria
- Unconsentable
- Not a candidate for corticosteroid injection
- Contraindication to lidocaine
Data sourced from ClinicalTrials.gov (NCT03630198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.