Spray vs EMLA Cream on Pain During Intra-articular Injection
- Conditions
- Adhesive Capsulitis of the Shoulder
- Interventions
- Registration Number
- NCT03484832
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 63
- Who had a normative schedule of intra-articular injection of shoulder
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Spray group Placebo Cream Using Walter Ritter Ethyl Chloride Spray and placebo cream Spray group Walter Ritter Ethyl Chloride Spray Using Walter Ritter Ethyl Chloride Spray and placebo cream EMLA group Placebo Spray Using EMLA cream and placebo spray Placebo group Placebo Spray Using placebo cream and placebo spray Placebo group Placebo Cream Using placebo cream and placebo spray EMLA group EMLA Cream Using EMLA cream and placebo spray
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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?"
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?''
Trial Locations
- Locations (1)
Soonchunhyang University Hospital, Bucheon
🇰🇷Bucheon, Gyeonggido, Korea, Republic of