Comparison of the Effects of Vapocoolant Spray and Topical Anesthetic Cream on Pain During Intra-articular Injection of Shoulder
Overview
- Phase
- Phase 4
- Intervention
- Walter Ritter Ethyl Chloride Spray
- Conditions
- Adhesive Capsulitis of the Shoulder
- Sponsor
- Soonchunhyang University Hospital
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Visual analog scale for injection pain
- Last Updated
- 7 years ago
Overview
Brief 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.
Detailed 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.
Investigators
SANGHYUN KIM
MD. PhD. Professor of Physical Medicine and Rehabilitation
Soonchunhyang University Hospital
Eligibility Criteria
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
Arms & Interventions
Spray group
Using Walter Ritter Ethyl Chloride Spray and placebo cream
Intervention: Walter Ritter Ethyl Chloride Spray
Spray group
Using Walter Ritter Ethyl Chloride Spray and placebo cream
Intervention: Placebo Cream
EMLA group
Using EMLA cream and placebo spray
Intervention: Placebo Spray
EMLA group
Using EMLA cream and placebo spray
Intervention: EMLA Cream
Placebo group
Using placebo cream and placebo spray
Intervention: Placebo Spray
Placebo group
Using placebo cream and placebo spray
Intervention: Placebo Cream
Outcomes
Primary Outcomes
Visual analog scale for injection pain
Time Frame: Within 5 minute
The 100-mm VAS consisted of a 100-mm horizontal line labeled ''no pain'' at the left and ''worst pain imaginable'' at the right.
Secondary Outcomes
- Five point Likert scale for preferences for future usage(Within 5 minute)
- Five point Likert scale for participant's satisfaction(Within 5 minute)