Vapocoolant Spray for Numbing Small Boils Before Incision and Drainage
|ClinicalTrials.gov Identifier: NCT01673061|
Recruitment Status : Terminated (Vapocoolant was not effective in controlling/preventing pain during an abscess incision and drainage when compared with Lidocaine.)
First Posted : August 27, 2012
Last Update Posted : June 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Abscess||Drug: Lidocaine Drug: Vapocoolant||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vapocoolant Spray as a Novel Local Anesthetic for Cutaneous Abscess Incision and Drainage|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||August 2014|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673061
|United States, Pennsylvania|
|Albert Einstein Medical Center|
|Philadelphia, Pennsylvania, United States, 19141|
|Principal Investigator:||Joseph D'Orazio, MD||Albert Einstein Healthcare Network|