Vapocoolant Spray for Numbing Small Boils Before Incision and Drainage

NCT01673061 | Terminated Phase 4 Results DMC

• 1 other identifier: HN 4405
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Abscess

Keywords

Abscess; Boils; Anesthetics, Local; Lidocaine; Vapocoolant; 1,1,1,3,3-Pentafluoropropane; 1,1,1,2-Tetrafluoroethane

Outcome Measures

Primary Outcomes (1)

• VNRS Pain Scale - Anesthetic Administration

  Visual Numeric Rating Scale (VNRS) for pain level at time of anesthetic administration on Day 1.

  Once, on Day 1, at time of anesthetic administration

Secondary Outcomes (5)

• VNRS Pain Scale - Incision and Drainage

  Once, on Day 1, at time of incision and drainage

• Change in VNRS - From Pre-anesthesia to Administration of Anesthesia

  Once, on Day 1

• Change in VNRS - From Pre-anesthesia to Post-procedure

  Once, on Day 1

• Willingness to Use Method of Anesthesia in the Future

  Once, on Day 1

• Unexpected Events

  Measured continuosly from consent to discharge, on Day 1.

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

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

Vapocoolant

ACTIVE COMPARATOR

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

Interventions

Lidocaine DRUG

See associated Arm Description

Also known as: Lidocaine with Epinephrine

Lidocaine

Vapocoolant DRUG

See associated Arm Description

Also known as: Gebauer's Pain Ease, Numbing Spray, 1,1,1,3,3-Pentafluoropropane, 1,1,1,2-Tetrafluoroethane

Vapocoolant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Related Publications (9)

• Singer AJ, Richman PB, Kowalska A, Thode HC Jr. Comparison of patient and practitioner assessments of pain from commonly performed emergency department procedures. Ann Emerg Med. 1999 Jun;33(6):652-8.

  PMID: 10339680 BACKGROUND

• Hijazi R, Taylor D, Richardson J. Effect of topical alkane vapocoolant spray on pain with intravenous cannulation in patients in emergency departments: randomised double blind placebo controlled trial. BMJ. 2009 Feb 10;338:b215. doi: 10.1136/bmj.b215.

  PMID: 19208703 BACKGROUND

• Costello M, Ramundo M, Christopher NC, Powell KR. Ethyl vinyl chloride vapocoolant spray fails to decrease pain associated with intravenous cannulation in children. Clin Pediatr (Phila). 2006 Sep;45(7):628-32. doi: 10.1177/0009922806291013.

  PMID: 16928840 BACKGROUND

• Cohen Reis E, Holubkov R. Vapocoolant spray is equally effective as EMLA cream in reducing immunization pain in school-aged children. Pediatrics. 1997 Dec;100(6):E5. doi: 10.1542/peds.100.6.e5.

  PMID: 9374583 BACKGROUND

• Mawhorter S, Daugherty L, Ford A, Hughes R, Metzger D, Easley K. Topical vapocoolant quickly and effectively reduces vaccine-associated pain: results of a randomized, single-blinded, placebo-controlled study. J Travel Med. 2004 Sep-Oct;11(5):267-72. doi: 10.2310/7060.2004.19101.

  PMID: 15544709 BACKGROUND

• Cannon CR, Replogle B. Fine-needle aspiration biopsy: is anesthesia necessary? Otolaryngol Head Neck Surg. 1999 Apr;120(4):458-9.

  PMID: 10187933 BACKGROUND

• Browne J, Awad I, Plant R, McAdoo J, Shorten G. Topical amethocaine (Ametop) is superior to EMLA for intravenous cannulation. Eutectic mixture of local anesthetics. Can J Anaesth. 1999 Nov;46(11):1014-8. doi: 10.1007/BF03013194.

  PMID: 10566919 BACKGROUND

• Biro P, Meier T, Cummins AS. Comparison of topical anaesthesia methods for venous cannulation in adults. Eur J Pain. 1997;1(1):37-42. doi: 10.1016/s1090-3801(97)90051-3.

  PMID: 15102427 BACKGROUND

• Rosier EM, Iadarola MJ, Coghill RC. Reproducibility of pain measurement and pain perception. Pain. 2002 Jul;98(1-2):205-16. doi: 10.1016/s0304-3959(02)00048-9.

  PMID: 12098633 BACKGROUND

MeSH Terms

Conditions

Abscess; Furunculosis

Interventions

Lidocaine; Epinephrine; 1,1,1,3,3-pentafluoropropane; norflurane

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Staphylococcal Skin Infections; Staphylococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Fish Diseases; Animal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Results Point of Contact

• Title: Kamran Mohiuddin, Director Clinical Research Emergency Medicine
• Organization: Albert Einstein Medical Center

mohiuddk@einstein.edu

2154562313

Study Officials

• Joseph D'Orazio, MD

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 27, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2014-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)