Pain Outcomes Following Intralesional Corticosteroid Injections

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Vanderbilt University Medical Center

Status and phase

Completed
Phase 4

Conditions

Granuloma Annulare
Acne
Lichen Planus
Epidermal Inclusion Cyst
Morphea
Nummular Eczema
Keratoacanthoma
Alopecia Areata
Keloid
Prurigo Nodularis
Lichen Simplex Chronicus
Hypertrophic Scar
Plaque Psoriasis
Frontal Fibrosing Alopecia
Lichen Plano-Pilaris

Treatments

Drug: Corticosteroid with normal saline
Drug: Corticosteroid with lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03630198
181119

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

31 participants in 2 patient groups

Corticosteroid with lidocaine
Active Comparator group
Description:
This arm will include an injection mixture of corticosteroid and lidocaine
Treatment:
Drug: Corticosteroid with lidocaine
Corticosteroid with normal saline
Experimental group
Description:
This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine.
Treatment:
Drug: Corticosteroid with normal saline

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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