Vapocoolant Spray for Numbing Small Boils Before Incision and Drainage

March 6, 2020 updated by: Albert Einstein Healthcare Network

Vapocoolant Spray as a Novel Local Anesthetic for Cutaneous Abscess Incision and Drainage

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VNRS Pain Scale - Anesthetic Administration
Time Frame: 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.
Once, on Day 1, at time of anesthetic administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VNRS Pain Scale - Incision and Drainage
Time Frame: 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.
Once, on Day 1, at time of incision and drainage
Change in VNRS - From Pre-anesthesia to Administration of Anesthesia
Time Frame: 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.
Once, on Day 1
Change in VNRS - From Pre-anesthesia to Post-procedure
Time Frame: 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.
Once, on Day 1
Willingness to Use Method of Anesthesia in the Future
Time Frame: 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.
Once, on Day 1
Unexpected Events
Time Frame: Measured continuosly from consent to discharge, on Day 1.
Any unexpected events that would occur during study period, including adverse events, on Day 1.
Measured continuosly from consent to discharge, on Day 1.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein Healthcare Network

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 23, 2012

First Posted (Estimate)

August 27, 2012

Study Record Updates

Last Update Posted (Actual)

March 19, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN 4405

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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