Abscess Clinical Trial
Official title:
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.
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.
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