Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections

Pain Clinical Trial

Official title:

Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027611
• Other study ID #: jsp-001
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2009
• Last updated: May 3, 2010
• Start date: October 2009
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: Illinois Retina Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

There are currently several different commercially available topical eye drops and gels used to reduce eye discomfort (topical anesthetics) during and after eye injections. Dr. Pollack is performing a research study to evaluate three commercially available topical anesthetics (eye numbing treatments) to determine if individuals have a preference for one over the other. The three topical anesthetics being studied are 1) 0.5% proparacaine hydrochloride (generic, Akorn, Inc), 2) 0.5% proparacaine hydrochloride (generic, Akorn, Inc) PLUS 4% lidocaine hydrochloride topical solution (generic, Roxane Laboratories), and 3) 3.5% lidocaine hydrochloride ophthalmic gel (Akten, Akorn, Inc). These eye anesthetics are NOT experimental medications. They are all commercially available topical anesthetics currently used in our offices and their use is widespread among retina specialists throughout the United States. Dr. Pollack will randomly select one topical anesthetic to use and he will ask you to grade your level of pain associated with the injection procedure. Answering these questions should take less than one minute of your time and your identity will NOT be revealed with the results of this study. The results of this study will be used to inform doctors which eye anesthetics patients find most effective for pain control during eye injections.

Description:

In this prospective study, 120 sequential patients undergoing 30 and 33 Gauge intravitreal injections were randomly assigned to receive either: proparacaine HCL 0.5% (Group 1), proparacaine HCL 0.5% + 4% lidocaine liquid drops (Group 2); or 3.5% lidocaine gel (Group 3) as topical anesthetic prior to injection. All procedures utilized a lid speculum and 5% povidone iodine. Approximately 10 seconds after injection, patients graded pain associated with the lid speculum, the needle, and with burning sensation on a pain scale of 0 to 10, with 0 representing no pain and 10 representing the patient's worst imaginable pain. They also graded their overall injection procedure experience as Excellent, Very Good, Fair, Poor, or Awful.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients requiring intravitreal injection for treatment of eye disease

Exclusion Criteria:

• Eye infection

• Retinal detachment

• Age less than 18 years

• Pregnant

• Unable or unwilling to provide informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• proparacaine HCL 0.5%

• proparacaine HCL 0.5% + 4% lidocaine solution

• 3.5% viscous lidocaine gel

Locations

Country	Name	City	State
United States	Illinois Retina Associates	Joliet	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Illinois Retina Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Injection experience "grade"		Outcome data is obtained approximately 10 seconds after conclusion of procedure	No
Secondary	Pain grades for lid speculum, needle insertion, povidone iodine burning/stinging		Outcome data is obtained approximately 10 seconds after conclusion of procedure	No