Vapocoolant Spray for Numbing Small Boils Before 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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vapocoolant Spray as a Novel Local Anesthetic for Cutaneous Abscess Incision and Drainage|
- VNRS pain scale - anesthetic administration [ Time Frame: Once, on Day 1, at time of anesthetic administration ] [ Designated as safety issue: No ]Visual Numeric Rating Scale (VNRS) for pain level at time of anesthetic administration on Day 1.
- VNRS pain scale - incision and drainage [ Time Frame: Once, on Day 1, at time of incision and drainage ] [ Designated as safety issue: No ]Visual 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 anesthesia [ Time Frame: Once, on Day 1 ] [ Designated as safety issue: No ]Difference 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-procedure [ Time Frame: Once, on Day 1 ] [ Designated as safety issue: No ]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.
- Willingness to use method of anesthesia in the future [ Time Frame: Once, on Day 1 ] [ Designated as safety issue: No ]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.
- Unexpected Events [ Time Frame: Measured continuosly from consent to discharge, on Day 1. ] [ Designated as safety issue: Yes ]Any unexpected events that would occur during study period, including adverse events, on Day 1.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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.
See associated Arm Description
Other Name: 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.
See associated Arm Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673061
|United States, Pennsylvania|
|Albert Einstein Medical Center|
|Philadelphia, Pennsylvania, United States, 19141|
|Principal Investigator:||Joseph D'Orazio, MD||Albert Einstein Healthcare Network|