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Spray vs EMLA Cream on Pain During Intra-articular Injection

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ClinicalTrials.gov Identifier: NCT03484832
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
SANGHYUN KIM, Soonchunhyang University Hospital

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 14, 2018
Estimated Primary Completion Date : March 19, 2020
Estimated Study Completion Date : May 19, 2020

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 Name: 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Five point Likert scale for participant's satisfaction [ Time Frame: 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?''

  2. Five point Likert scale for preferences for future usage [ Time Frame: 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?"



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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484832


Contacts
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Contact: SANGHYUN KIM 821023577324 sanghyunkim71@gmail.com

Locations
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Korea, Republic of
Soonchunhyang University Hospital, Bucheon Recruiting
Bucheon, Gyeonggido, Korea, Republic of, 420767
Contact: SANGHYUN KIM    821023577324    sanghyunkim71@gmail.com   
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
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Principal Investigator: SANGHYUN KIM Soonchunhyang University Hospital

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Responsible Party: SANGHYUN KIM, MD. PhD. Professor of Physical Medicine and Rehabilitation, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT03484832     History of Changes
Other Study ID Numbers: EMLA SPRAY
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases
Lidocaine, Prilocaine Drug Combination
Ethyl Chloride
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Combined