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Vapocoolant Spray for Numbing Small Boils Before Incision and Drainage

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01673061
Enrollment
21
Registered
2012-08-27
Start date
2012-08-31
Completion date
2013-08-31
Last updated
2020-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abscess

Keywords

Abscess, Boils, Anesthetics, Local, Lidocaine, Vapocoolant, 1,1,1,3,3-Pentafluoropropane, 1,1,1,2-Tetrafluoroethane

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.

Interventions

DRUGLidocaine

See associated Arm Description

See associated Arm Description

Sponsors

Albert Einstein Healthcare Network
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
VNRS Pain Scale - Anesthetic AdministrationOnce, on Day 1, at time of anesthetic administrationVisual Numeric Rating Scale (VNRS) for pain level at time of anesthetic administration on Day 1.

Secondary

MeasureTime frameDescription
VNRS Pain Scale - Incision and DrainageOnce, on Day 1, at time of incision and drainageVisual 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 AnesthesiaOnce, on Day 1Difference 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-procedureOnce, on Day 1Difference 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 FutureOnce, on Day 1Willingness 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 EventsMeasured continuosly from consent to discharge, on Day 1.Any unexpected events that would occur during study period, including adverse events, on Day 1.

Countries

United States

Participant flow

Recruitment details

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

Pre-assignment details

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

Participants by arm

ArmCount
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. Lidocaine: See associated Arm Description
0
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. Vapocoolant: See associated Arm Description
0
Total0

Baseline characteristics

Characteristic
Region of Enrollment
United States
— participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

VNRS Pain Scale - Anesthetic Administration

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

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

Secondary

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.

Time frame: Once, on Day 1

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

Secondary

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.

Time frame: Once, on Day 1

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

Secondary

Unexpected Events

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.

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

Secondary

VNRS Pain Scale - Incision and Drainage

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

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

Secondary

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.

Time frame: Once, on Day 1

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

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026