Vapocoolant Spray for Numbing Small Boils Before Incision and Drainage

This study has been terminated.
(Vapocoolant was not effective in controlling/preventing pain during an abscess incision and drainage when compared with Lidocaine.)
Sponsor:
Information provided by (Responsible Party):
Joseph D'Orazio, MD, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier:
NCT01673061
First received: August 14, 2012
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Abscess
Drug: Lidocaine
Drug: Vapocoolant
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Albert Einstein Healthcare Network:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 21
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673061

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

Publications:

Responsible Party: Joseph D'Orazio, MD, Attending Physician, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT01673061     History of Changes
Other Study ID Numbers: HN 4405
Study First Received: August 14, 2012
Last Updated: June 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein Healthcare Network:
Abscess
Boils
Anesthetics, Local
Lidocaine
Vapocoolant
1,1,1,3,3-Pentafluoropropane
1,1,1,2-Tetrafluoroethane

Additional relevant MeSH terms:
Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Epinephrine
Lidocaine
Anesthetics
Norflurane
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Central Nervous System Depressants
Central Nervous System Agents
Anesthetics, Local

ClinicalTrials.gov processed this record on July 28, 2014