Vapocoolant Spray for Numbing Small Boils Before Incision and Drainage

• Sponsor: Albert Einstein Healthcare Network (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01673061
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Abscess	Drug: Lidocaine; Drug: Vapocoolant	Phase 4

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.

1. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Vapocoolant Spray as a Novel Local Anesthetic for Cutaneous Abscess Incision and Drainage
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lidocaine 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.	Drug: Lidocaine; See associated Arm Description; Other Names: Lidocaine with Epinephrine
Active Comparator: Vapocoolant 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.	Drug: Vapocoolant; See associated Arm Description; Other Names: Gebauer's Pain Ease Numbing Spray 1,1,1,3,3-Pentafluoropropane 1,1,1,2-Tetrafluoroethane

Outcome Measures

Primary Outcome Measures

1. VNRS Pain Scale - Anesthetic Administration [Once, on Day 1, at time of anesthetic administration]

   Visual Numeric Rating Scale (VNRS) for pain level at time of anesthetic administration on Day 1.

Secondary Outcome Measures

1. VNRS Pain Scale - Incision and Drainage [Once, on Day 1, at time of incision and drainage]

   Visual Numeric Rating Scale (VNRS) for pain level during incision and drainage of the abscess on Day 1.

2. Change in VNRS - From Pre-anesthesia to Administration of Anesthesia [Once, on Day 1]

   Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at the moment of anesthesia administration, on Day 1.

3. Change in VNRS - From Pre-anesthesia to Post-procedure [Once, on Day 1]

   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.

4. Willingness to Use Method of Anesthesia in the Future [Once, on Day 1]

   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.

5. Unexpected Events [Measured continuosly from consent to discharge, on Day 1.]

   Any unexpected events that would occur during study period, including adverse events, on Day 1.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Albert Einstein Medical Center	Philadelphia	Pennsylvania	United States	19141

Sponsors and Collaborators

• Albert Einstein Healthcare Network

Investigators

• Principal Investigator: Joseph D'Orazio, MD, Albert Einstein Healthcare Network

Study Documents (Full-Text)

None provided.

More Information

Publications

• Biro P, Meier T, Cummins AS. Comparison of topical anaesthesia methods for venous cannulation in adults. Eur J Pain. 1997;1(1):37-42.
• 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.
• Cannon CR, Replogle B. Fine-needle aspiration biopsy: is anesthesia necessary? Otolaryngol Head Neck Surg. 1999 Apr;120(4):458-9.
• Cohen Reis E, Holubkov R. Vapocoolant spray is equally effective as EMLA cream in reducing immunization pain in school-aged children. Pediatrics. 1997 Dec;100(6):E5.
• 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.
• Hijazi R, Taylor D, Richardson J. Effect of topical alkane vapocoolant spray on pain with intravenous cannulation in patients in emergency departments: randomised double blind placebo controlled trial. BMJ. 2009 Feb 10;338:b215. doi: 10.1136/bmj.b215.
• Mawhorter S, Daugherty L, Ford A, Hughes R, Metzger D, Easley K. Topical vapocoolant quickly and effectively reduces vaccine-associated pain: results of a randomized, single-blinded, placebo-controlled study. J Travel Med. 2004 Sep-Oct;11(5):267-72.
• Rosier EM, Iadarola MJ, Coghill RC. Reproducibility of pain measurement and pain perception. Pain. 2002 Jul;98(1-2):205-16.
• Singer AJ, Richman PB, Kowalska A, Thode HC Jr. Comparison of patient and practitioner assessments of pain from commonly performed emergency department procedures. Ann Emerg Med. 1999 Jun;33(6):652-8.

• Responsible Party: Albert Einstein Healthcare Network
• ClinicalTrials.gov Identifier: NCT01673061
• Other Study ID Numbers: HN 4405
• First Posted: Aug 27, 2012
• Last Update Posted: Mar 19, 2020
• Last Verified: Jun 1, 2014

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Albert Einstein Healthcare Network: Abscess; Boils; Anesthetics, Local; Lidocaine; Vapocoolant; 1,1,1,3,3-Pentafluoropropane; 1,1,1,2-Tetrafluoroethane
• Additional relevant MeSH terms: Abscess; Lidocaine; Epinephrine; Norflurane

Study Results

Participant Flow

Recruitment Details	0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Pre-assignment Detail	0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Arm/Group Title	Lidocaine	Vapocoolant
Arm/Group 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. Lidocaine: See associated 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. Vapocoolant: See associated Arm Description
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Lidocaine	Vapocoolant	Total
Arm/Group 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. Lidocaine: See associated 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. Vapocoolant: See associated Arm Description	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Arm/Group Title	Lidocaine	Vapocoolant
Arm/Group 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. Lidocaine: See associated 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. Vapocoolant: See associated Arm Description
Measure Participants	0	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Arm/Group Title	Lidocaine	Vapocoolant
Arm/Group 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. Lidocaine: See associated 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. Vapocoolant: See associated Arm Description
Measure Participants	0	0

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Arm/Group Title	Lidocaine	Vapocoolant
Arm/Group 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. Lidocaine: See associated 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. Vapocoolant: See associated Arm Description
Measure Participants	0	0

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Arm/Group Title	Lidocaine	Vapocoolant
Arm/Group 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. Lidocaine: See associated 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. Vapocoolant: See associated Arm Description
Measure Participants	0	0

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Arm/Group Title	Lidocaine	Vapocoolant
Arm/Group 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. Lidocaine: See associated 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. Vapocoolant: See associated Arm Description
Measure Participants	0	0

6. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Arm/Group Title	Lidocaine	Vapocoolant
Arm/Group 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. Lidocaine: See associated 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. Vapocoolant: See associated Arm Description
Measure Participants	0	0

Adverse Events

Time Frame	0
Adverse Event Reporting Description	0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Arm/Group Title	Lidocaine		Vapocoolant
Arm/Group 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. Lidocaine: See associated 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. Vapocoolant: See associated Arm Description
All Cause Mortality
	Lidocaine		Vapocoolant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Lidocaine		Vapocoolant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Lidocaine		Vapocoolant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.