Ignite Creation Date:
2024-05-06 @ 12:52 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01673061
Status:
TERMINATED
Last Update Posted:
2020-03-19
First Post:
2012-08-14
Brief Title:
Vapocoolant Spray for Numbing Small Boils Before Incision and Drainage
Sponsor:
Albert Einstein Healthcare Network
Organization:
Albert Einstein Healthcare Network
Study Overview
Official Title:
Vapocoolant Spray as a Novel Local Anesthetic for Cutaneous Abscess Incision and Drainage
Status:
TERMINATED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Vapocoolant not effective controlling pain compared with Lidocaine
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1Non-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 attendingsenior 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 11133-Pentafluoropropane and 1112-Tetrafluoroethane spray Gebauers 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 ID 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
Specific aims 1Non-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 attendingsenior 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 11133-Pentafluoropropane and 1112-Tetrafluoroethane spray Gebauers 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 ID 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None