drugset / Trial / NCT03484832

Spray vs EMLA Cream on Pain During Intra-articular Injection

NCT03484832 ↗

Phase 4 Unknown 63 enrolled Soonchunhyang University Hospital
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2018-03-14
Primary completion
2020-03-19
Completion
2020-05-19

Drugs

EvaluationDrugModalityDoseRoute
Subject EMLA Cream Unknown — Topical

Indications