Spray vs EMLA Cream on Pain During Intra-articular Injection

Sponsor

Soonchunhyang University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03484832

Collaborator

(none)

Enrollment

Location

Arms

26.2

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adhesive Capsulitis of the Shoulder	Device: Walter Ritter Ethyl Chloride Spray Other: Placebo Spray Other: Placebo Cream Drug: EMLA Cream	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 14, 2018

Anticipated Primary Completion Date :

Mar 19, 2020

Anticipated Study Completion Date :

May 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Spray group Using Walter Ritter Ethyl Chloride Spray and placebo cream	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 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.
Experimental: EMLA group Using EMLA cream and placebo spray	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. 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. Other Names: EMLA 5% cream
Placebo Comparator: Placebo group Using placebo cream and placebo spray	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. Other: 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.

Arm

Intervention/Treatment

Experimental: Spray group

Using Walter Ritter Ethyl Chloride Spray and placebo cream

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 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.

Experimental: EMLA group

Using EMLA cream and placebo spray

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.

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.

Other Names:

EMLA 5% cream

Placebo Comparator: Placebo group

Using placebo cream and placebo spray

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.

Other: Placebo Cream

Outcome Measures

Primary Outcome Measures

Visual analog scale for injection pain [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 Outcome Measures

Five point Likert scale for participant's satisfaction [Within 5 minute]
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?''
Five point Likert scale for preferences for future usage [Within 5 minute]
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?"

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Soonchunhyang University Hospital, Bucheon	Bucheon	Gyeonggido	Korea, Republic of	420767

Sponsors and Collaborators

Soonchunhyang University Hospital

Investigators

Principal Investigator: SANGHYUN KIM, Soonchunhyang University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SANGHYUN KIM, MD. PhD. Professor of Physical Medicine and Rehabilitation, Soonchunhyang University Hospital

ClinicalTrials.gov Identifier:

NCT03484832

Other Study ID Numbers:

EMLA SPRAY

First Posted:

Apr 2, 2018

Last Update Posted:

Apr 8, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Bursitis

Lidocaine, Prilocaine Drug Combination

Ethyl Chloride

Study Results

No Results Posted as of Apr 8, 2019