Injectable Lidocaine Versus Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses

Pain Clinical Trial

Official title:

Injectable Lidocaine Provides Similar Analgesia Compared to Transdermal Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066818
• Other study ID #: ECUEM-Synera
• Status: Completed
• Phase: Phase 0
• First received: November 18, 2013
• Last updated: February 18, 2014
• Start date: January 2008
• Est. completion date: January 2010

Study information

• Verified date: February 2014
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Local anesthesia used for incision and drainage of abscesses is known to be painful.

We studied the analgesia provided by a lidocaine/tetracaine patch compared to injectable lidocaine during incision and drainage (I&D) of skin abscesses.

Local injection of lidocaine provided similar analgesia compared to the lidocaine/tetracaine patch during I&D of skin abscesses in the Emergency Department. Pain at presentation and following the procedure was similar in both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age>18 years

• Skin abscess in need of incision and drainage (judged by treating physician)

Exclusion Criteria:

• Allergy to lidocaine or tetracaine

• Non-intact skin

• Unable/unwilling to provide informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Abscess
• Cutaneous Abscess
• Pain

Intervention

Drug:
• Lidocaine/tetracaine patch

• 1% lidocaine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in VAS pain score over time	VAS measured at each of the 3 time points noted above.	Immediately prior to starting I&D (Time 0); 2-5 minutes after start of I&D (Time 1); within 1 minute of completion of I&D (Time 2)	No