Spray vs EMLA Cream on Pain During Intra-articular Injection

Phase

Condition

Bursitis

Treatment

N/A

Clinical Study ID

NCT03484832

EMLA SPRAY

Ages 19-70
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

those who refused to participate, those who were unable to understand a visual analogscale or a Likert scale, those with a history of an allergic reaction to vapocoolantspray 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 24hours, those with prior history of intra-articular injection of shoulder, those whoexhibited an abnormal shoulder sensation on neurologic examination

Study Design

March 14, 2018

May 19, 2020

Study 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.

Connect with a study center

Soonchunhyang University Hospital, Bucheon
Bucheon, Gyeonggido 420767
Korea, Republic of
Active - Recruiting

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