We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vapocoolant Spray for Numbing Small Boils Before Incision and Drainage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by (Responsible Party):
Joseph D'Orazio, MD, Albert Einstein Healthcare Network

August 14, 2012
August 27, 2012
June 23, 2014
August 2012
August 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01673061 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Vapocoolant Spray for Numbing Small Boils Before Incision and Drainage
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Abscess
  • Drug: Lidocaine
    See associated Arm Description
    Other Name: Lidocaine with Epinephrine
  • Drug: Vapocoolant
    See associated Arm Description
    Other Names:
    • Gebauer's Pain Ease
    • Numbing Spray
    • 1,1,1,3,3-Pentafluoropropane
    • 1,1,1,2-Tetrafluoroethane
  • 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.
    Intervention: Drug: Lidocaine
  • 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.
    Intervention: Drug: Vapocoolant

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
21
August 2014
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Greater than or equal to 18 years old
  • Able to consent
  • Has cutaneous abscess less than or equal to 2 centimeters requiring incision and drainage in the Emergency Department

Exclusion Criteria:

  • Less than 18 years old
  • Unable to consent
  • Pregnant or breastfeeding
  • Prisoner or in police custody
  • Known sensitivity to vapocoolant or lidocaine
  • Cold hypersensitivity
  • Chronic steroid use
  • Peripheral neuropathy
  • Diabetes
  • HIV
  • Malignancy
  • Immunosuppressive state
  • Sickle cell disease
  • Sarcoidosis
  • Abscess greater than 2 centimeters in any dimension
  • Abscess requiring procedural sedation and analgesia for incision and drainage, or further intervention outside the Emergency Department
  • Abscess located on the hands, feet, face, or perineal areas
  • Pilonidal cyst
  • hidradenitis suppurativa
  • Not a good candidate per attending physician
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01673061
HN 4405
Yes
Not Provided
Not Provided
Joseph D'Orazio, MD, Albert Einstein Healthcare Network
Albert Einstein Healthcare Network
Not Provided
Principal Investigator: Joseph D'Orazio, MD Albert Einstein Healthcare Network
Albert Einstein Healthcare Network
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP