Spray vs EMLA Cream on Pain During Intra-articular Injection

Soon Chun Hyang University

Status and phase: Unknown; Phase 4

Conditions: Adhesive Capsulitis of the Shoulder

Treatments: Drug: EMLA Cream; Other: Placebo Spray; Device: Walter Ritter Ethyl Chloride Spray; Other: Placebo Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT03484832

EMLA SPRAY

Details and patient eligibility

About

All participants are randomly allocated to the spray group, EMLA group and placebo group. In spray group, participants receive an application of placebo cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed from a distance of 30 cm for 5 seconds or until the skin was blanched, then intra-articular injection of shoulder is performed. Immediately after injection, participants are asked to fill out the visual analog scale for injectional pain, five point Likert scale for satisfaction about the topical anesthesia. In EMLA group, participants receive an EMLA cream and placebo spray. In placebo group, participants receive a placebo cream and placebo spray.

Full description

All participants are randomly allocated to the spray group, EMLA group and placebo group.

In spray group, participants receive an application of placebo cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed using ethyl chloride spray (Walter Ritter GmbH and Co., Hamburg, Germany) from a distance of 30 cm for 5 seconds or until the skin was blanched, then intra-articular injection of shoulder is performed. Immediately after injection, participants are asked to fill out the visual analog scale for injectional pain, five point Likert scale for satisfaction about the topical anesthesia.

In EMLA group, participants receive an application of EMLA cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed using placebo spray (Evain Eau Minerale Naturelle, a pure water spray with hydrocarbon propellant), then intra-articular injection of shoulder is performed. Immediately after injection, participants are asked to fill out the same scales.

In placebo group, participants receive a placebo cream and placebo spray.

Enrollment: 63 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Who had a normative schedule of intra-articular injection of shoulder

Exclusion criteria

• those who refused to participate, those who were unable to understand a visual analog scale or a Likert scale, those with a history of an allergic reaction to vapocoolant spray or lidocaine, those with a history of cold intolerance (eg, Raynaud syndrome), those who took pain medications or had used topical anesthetics within the previous 24 hours, those with prior history of intra-articular injection of shoulder, those who exhibited an abnormal shoulder sensation on neurologic examination

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 3 patient groups, including a placebo group

Spray group

Experimental group

Description:

Using Walter Ritter Ethyl Chloride Spray and placebo cream

Treatment:

Device: Walter Ritter Ethyl Chloride Spray

Other: Placebo Cream

EMLA group

Experimental group

Description:

Using EMLA cream and placebo spray

Treatment:

Other: Placebo Spray

Drug: EMLA Cream

Placebo group

Placebo Comparator group

Description:

Using placebo cream and placebo spray

Treatment:

Other: Placebo Spray

Other: Placebo Cream