Vapocoolant Spray for Numbing Small Boils Before Incision and Drainage
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|