Vapocoolant Spray for Numbing Small Boils Before Incision and Drainage
Primary Purpose
Abscess
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidocaine
Vapocoolant
Sponsored by
About this trial
This is an interventional treatment trial for Abscess focused on measuring Abscess, Boils, Anesthetics, Local, Lidocaine, Vapocoolant, 1,1,1,3,3-Pentafluoropropane, 1,1,1,2-Tetrafluoroethane
Eligibility Criteria
Inclusion Criteria:
- Greater than or equal to 18 years old
- Able to consent
- Has cutaneous abscess less than or equal to 2 centimeters requiring incision and drainage in the Emergency Department
Exclusion Criteria:
- Less than 18 years old
- Unable to consent
- Pregnant or breastfeeding
- Prisoner or in police custody
- Known sensitivity to vapocoolant or lidocaine
- Cold hypersensitivity
- Chronic steroid use
- Peripheral neuropathy
- Diabetes
- HIV
- Malignancy
- Immunosuppressive state
- Sickle cell disease
- Sarcoidosis
- Abscess greater than 2 centimeters in any dimension
- Abscess requiring procedural sedation and analgesia for incision and drainage, or further intervention outside the Emergency Department
- Abscess located on the hands, feet, face, or perineal areas
- Pilonidal cyst
- hidradenitis suppurativa
- Not a good candidate per attending physician
Sites / Locations
- Albert Einstein Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lidocaine
Vapocoolant
Arm Description
Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.
Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.
Outcomes
Primary Outcome Measures
VNRS Pain Scale - Anesthetic Administration
Visual Numeric Rating Scale (VNRS) for pain level at time of anesthetic administration on Day 1.
Secondary Outcome Measures
VNRS Pain Scale - Incision and Drainage
Visual Numeric Rating Scale (VNRS) for pain level during incision and drainage of the abscess on Day 1.
Change in VNRS - From Pre-anesthesia to Administration of Anesthesia
Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at the moment of anesthesia administration, on Day 1.
Change in VNRS - From Pre-anesthesia to Post-procedure
Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at after all aspects of incision and drainage are complete, on Day 1.
Willingness to Use Method of Anesthesia in the Future
Willingness of the subject to use their assigned method of anesthesia again if they were to require the same procedure in the future. Measured once on Day 1.
Unexpected Events
Any unexpected events that would occur during study period, including adverse events, on Day 1.
Full Information
NCT ID
NCT01673061
First Posted
August 14, 2012
Last Updated
March 6, 2020
Sponsor
Albert Einstein Healthcare Network
1. Study Identification
Unique Protocol Identification Number
NCT01673061
Brief Title
Vapocoolant Spray for Numbing Small Boils Before Incision and Drainage
Official Title
Vapocoolant Spray as a Novel Local Anesthetic for Cutaneous Abscess Incision and Drainage
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
Vapocoolant not effective controlling pain compared with Lidocaine.
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein Healthcare Network
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cutaneous abscesses (boils) are collections of pus or infection in the skin, and are a frequent reason for emergency department visits. The only proven cure for abscesses is cutting them open and allowing the infection to drain, but this procedure is often painful. Currently, the usual method of pain control is to inject a numbing medication (lidocaine) into the site, but this injection itself is often painful and sometimes does not offer full pain relief. Although there has been some research into the use of non-injected numbing agents as another option, no studies have looked at the use of numbing sprays (vapocoolant) in this context specifically. The hypothesis of this study is that numbing spray is as good as injected numbing medication at relieving pain in patients having small abscesses opened and drained. This theory will be tested by taking two groups of patients having small abscesses drained in the Emergency Department, and assigning one group to get a numbing injection, and the other to get a numbing spray. Their levels of pain and satisfaction will be recorded before, during, and after the procedure, and the two groups will be compared.
Detailed Description
Hypotheses: Patients would have a similar amount of pain with incision and drainage using local infiltration of anesthetic as with application of a vapocoolant spray and the pain of the administration of anesthesia would be similar or reduced with the use of the vapocoolant spray.
Specific aims: 1.Non-inferiority in pain of anesthesia administration and incision and drainage of small abscesses by finding no significant difference of patient pain as measured on the VRNS scale.
2. Show that patients were willing to undergo anesthesia again with a vapocoolant spray as assesed by the Likert scale Long term goals- To implement the use of vapocoolant sprays as an alternative form of anesthesia for incision and drainage of abscesses
The primary outcome measure for this study would be the finding of no significant difference in the pain as measured by the VRNS between the two arms for administration of anesthesia. Secondary measures would be finding no significant difference in VRNS for incisional and drainage, and change in VRNS from presentation to anesthesia, and to incision and drainage, willingness of the patient to choose the allocated sprayin the future, and unexpected events.
Initial medical assessment will be made by an attending/senior resident in accordance with established clinical procedures, including the history, physical examination, and vital signs. If by clinical assessment the patients meet eligibility criteria, then they will be approached by a research associate for screening, informed consent process, enrollment in the study, and data collection. Following the screening questionnaire, the research associate will hold thorough discussion about the study. The patients will be given as much time as they require to understand and make an informed decision. A formal written consent will be obtained if patients agree to participate. After the patient understands and signs the informed consent form, they will be randomized to either the placebo group or treatment group by using a randomization scheme. The treating physician will measure erythema and induration using a measuring tape, estimate the amount of fluctuance as small, moderate, or large, and note the location of the abscess. Once randomized, subjects will be given a VRNS scale to rate their pain upon initial presentation The treating physician will clean the abscess with chlorhexidine solution then either spray the skin overlying the abscess with 1,1,1,3,3-Pentafluoropropane and 1,1,1,2-Tetrafluoroethane spray (Gebauer's Pain Ease® Medium Stream Spray) at a distance of 12 cm from the site for a duration of 2 seconds or infiltrate the abscess with 2% lidocaine with epinepherine (amount determinted by treating physician). Any reactions to the vapocoolant administration will be noted. The abscess will then be incised with a No. 11 surgical scalpel, and a cotton tipped applicator will be used to break up loculations within the abscess cavity. The method of I&D, and decision to probe to break-up loculations will be standardized, but the degree of probing, and decision to pack will be left to the discretion of the treating physician. Subjects will be asked by the research assistant to describe the discomfort of the abscess using the Visual Numerical Rating Scale (VRNS) during vapocoolant administration, during incision of the abscess, and after the procedure is complete.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscess
Keywords
Abscess, Boils, Anesthetics, Local, Lidocaine, Vapocoolant, 1,1,1,3,3-Pentafluoropropane, 1,1,1,2-Tetrafluoroethane
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Lidocaine injection will be used for anesthesia prior to incision and drainage. 2% Lidocaine with epinephrine will be injected into the abscess site. Amount injected will be per physician discretion.
Arm Title
Vapocoolant
Arm Type
Active Comparator
Arm Description
Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Lidocaine with Epinephrine
Intervention Description
See associated Arm Description
Intervention Type
Drug
Intervention Name(s)
Vapocoolant
Other Intervention Name(s)
Gebauer's Pain Ease, Numbing Spray, 1,1,1,3,3-Pentafluoropropane, 1,1,1,2-Tetrafluoroethane
Intervention Description
See associated Arm Description
Primary Outcome Measure Information:
Title
VNRS Pain Scale - Anesthetic Administration
Description
Visual Numeric Rating Scale (VNRS) for pain level at time of anesthetic administration on Day 1.
Time Frame
Once, on Day 1, at time of anesthetic administration
Secondary Outcome Measure Information:
Title
VNRS Pain Scale - Incision and Drainage
Description
Visual Numeric Rating Scale (VNRS) for pain level during incision and drainage of the abscess on Day 1.
Time Frame
Once, on Day 1, at time of incision and drainage
Title
Change in VNRS - From Pre-anesthesia to Administration of Anesthesia
Description
Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at the moment of anesthesia administration, on Day 1.
Time Frame
Once, on Day 1
Title
Change in VNRS - From Pre-anesthesia to Post-procedure
Description
Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at after all aspects of incision and drainage are complete, on Day 1.
Time Frame
Once, on Day 1
Title
Willingness to Use Method of Anesthesia in the Future
Description
Willingness of the subject to use their assigned method of anesthesia again if they were to require the same procedure in the future. Measured once on Day 1.
Time Frame
Once, on Day 1
Title
Unexpected Events
Description
Any unexpected events that would occur during study period, including adverse events, on Day 1.
Time Frame
Measured continuosly from consent to discharge, on Day 1.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Greater than or equal to 18 years old
Able to consent
Has cutaneous abscess less than or equal to 2 centimeters requiring incision and drainage in the Emergency Department
Exclusion Criteria:
Less than 18 years old
Unable to consent
Pregnant or breastfeeding
Prisoner or in police custody
Known sensitivity to vapocoolant or lidocaine
Cold hypersensitivity
Chronic steroid use
Peripheral neuropathy
Diabetes
HIV
Malignancy
Immunosuppressive state
Sickle cell disease
Sarcoidosis
Abscess greater than 2 centimeters in any dimension
Abscess requiring procedural sedation and analgesia for incision and drainage, or further intervention outside the Emergency Department
Abscess located on the hands, feet, face, or perineal areas
Pilonidal cyst
hidradenitis suppurativa
Not a good candidate per attending physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph D'Orazio, MD
Organizational Affiliation
Albert Einstein Healthcare Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
10339680
Citation
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Results Reference
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PubMed Identifier
19208703
Citation
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Results Reference
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PubMed Identifier
16928840
Citation
Costello M, Ramundo M, Christopher NC, Powell KR. Ethyl vinyl chloride vapocoolant spray fails to decrease pain associated with intravenous cannulation in children. Clin Pediatr (Phila). 2006 Sep;45(7):628-32. doi: 10.1177/0009922806291013.
Results Reference
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PubMed Identifier
9374583
Citation
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Results Reference
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PubMed Identifier
15544709
Citation
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Results Reference
background
PubMed Identifier
10187933
Citation
Cannon CR, Replogle B. Fine-needle aspiration biopsy: is anesthesia necessary? Otolaryngol Head Neck Surg. 1999 Apr;120(4):458-9.
Results Reference
background
PubMed Identifier
10566919
Citation
Browne J, Awad I, Plant R, McAdoo J, Shorten G. Topical amethocaine (Ametop) is superior to EMLA for intravenous cannulation. Eutectic mixture of local anesthetics. Can J Anaesth. 1999 Nov;46(11):1014-8. doi: 10.1007/BF03013194.
Results Reference
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PubMed Identifier
15102427
Citation
Biro P, Meier T, Cummins AS. Comparison of topical anaesthesia methods for venous cannulation in adults. Eur J Pain. 1997;1(1):37-42. doi: 10.1016/s1090-3801(97)90051-3.
Results Reference
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PubMed Identifier
12098633
Citation
Rosier EM, Iadarola MJ, Coghill RC. Reproducibility of pain measurement and pain perception. Pain. 2002 Jul;98(1-2):205-16. doi: 10.1016/s0304-3959(02)00048-9.
Results Reference
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Vapocoolant Spray for Numbing Small Boils Before Incision and Drainage
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