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. 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
Information provided by (Responsible Party):
Joseph D'Orazio, MD, Albert Einstein Healthcare Network

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.

Condition or disease Intervention/treatment Phase
Abscess Drug: Lidocaine Drug: Vapocoolant Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Arm Intervention/treatment
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.
Drug: Lidocaine
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.
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01673061

United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Albert Einstein Healthcare Network
Principal Investigator: Joseph D'Orazio, MD Albert Einstein Healthcare Network


Responsible Party: Joseph D'Orazio, MD, Attending Physician, Albert Einstein Healthcare Network Identifier: NCT01673061     History of Changes
Other Study ID Numbers: HN 4405
First Posted: August 27, 2012    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014

Keywords provided by Joseph D'Orazio, MD, Albert Einstein Healthcare Network:
Anesthetics, Local

Additional relevant MeSH terms:
Pathologic Processes
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents