Spray vs EMLA Cream on Pain During Intra-articular Injection

Adhesive Capsulitis of the Shoulder Clinical Trial

Official title:

Comparison of the Effects of Vapocoolant Spray and Topical Anesthetic Cream on Pain During Intra-articular Injection of Shoulder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03484832
• Other study ID #: EMLA SPRAY
• Status: Recruiting
• Phase: Phase 4
• Start date: March 14, 2018
• Est. completion date: May 19, 2020

Study information

• Verified date: April 2019
• Source: Soonchunhyang University Hospital
• Contact: SANGHYUN KIM
• Phone: 821023577324
• Email: sanghyunkim71[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: May 19, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis of the Shoulder
• Bursitis

Intervention

Device:
• Walter Ritter Ethyl Chloride Spray
Participants receive an application of EMLA or 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.

Other:
• Placebo Spray
Participants receive an application of EMLA or 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 placebo spray (Evain Eau Minerale Naturelle, a pure water spray with hydrocarbon propellant), then intra-articular injection of shoulder is performed.
• Placebo Cream
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 Walter Ritter Ethyl chloride spray or placebo spray, then intra-articular injection of shoulder is performed.

Drug:
• EMLA Cream
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 Walter Ritter Ethyl chloride spray or placebo spray, then intra-articular injection of shoulder is performed.

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Hospital, Bucheon	Bucheon	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale for injection pain	The 100-mm VAS consisted of a 100-mm horizontal line labeled ''no pain'' at the left and ''worst pain imaginable'' at the right.	Within 5 minute
Secondary	Five point Likert scale for participant's satisfaction	The five-point Likert scale (1, strongly agree; 2, agree; 3, undecided; 4, disagree; and 5, strongly disagree) is used to answer the question: ''Are you satisfied with the topical anesthetic methods used before performing the shoulder intra-articular injection?''	Within 5 minute
Secondary	Five point Likert scale for preferences for future usage	The five-point Likert scale (1, strongly agree; 2, agree; 3, undecided; 4, disagree; and 5, strongly disagree) is used to answer the question: "Would you use the topical anesthetic methods applied today again if the shoulder intra-articular injection is repeated in the future?"	Within 5 minute