Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients

Sponsor

Mahidol University (Other)

Overall Status

Terminated

CT.gov ID

NCT00789646

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

The propose of this study is to determine the efficacy of 2% xylocaine in reducing pain due to subconjunctival antibiotic and antifungal injection.

Condition or Disease	Intervention/Treatment	Phase
Corneal Ulcer	Procedure: Lidocaine/NSS Procedure: NSS/Lidocaine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients.

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NSS/Lidocaine First injection: Normal saline Second injection: 2% Lidocaine without adrenaline	Procedure: NSS/Lidocaine First injection: subconjunctival NSS 0.4 ml. before antibiotic injection Second injection (24 hours later): subconjunctival 2% lidocaine without adrenaline 0.4 ml. before antibiotic injection
Experimental: Lidocaine/NSS First injection: 2% Lidocaine without adrenaline Second injection: Normal saline	Procedure: Lidocaine/NSS First injection: subconjunctival 2% lidocaine without adrenaline 0.4 ml. before antibiotic injection Second injection (24 hours later): subconjunctival NSS 0.4 ml. before antibiotic injection

Arm

Intervention/Treatment

Experimental: NSS/Lidocaine

First injection: Normal saline Second injection: 2% Lidocaine without adrenaline

Procedure: NSS/Lidocaine

First injection: subconjunctival NSS 0.4 ml. before antibiotic injection Second injection (24 hours later): subconjunctival 2% lidocaine without adrenaline 0.4 ml. before antibiotic injection

Experimental: Lidocaine/NSS

First injection: 2% Lidocaine without adrenaline Second injection: Normal saline

Procedure: Lidocaine/NSS

First injection: subconjunctival 2% lidocaine without adrenaline 0.4 ml. before antibiotic injection Second injection (24 hours later): subconjunctival NSS 0.4 ml. before antibiotic injection

Outcome Measures

Primary Outcome Measures

Numeric rating scale [immediately after injection]

Secondary Outcome Measures

Side effects [24 hours after injection]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The corneal ulcer patients who are diagnosed by ophthalmologist and have 2 of 3 in these following features.

corneal epithelial defect with stromal infiltration
reaction in anterior chamber
positive for bacteria or fungus

The patients have to receive subconjunctival antibiotic injection twice at least.
The patients must be informed consent.

Exclusion Criteria:

The patients who have history of allergy of local anesthetics, antibiotics or antifungal drugs.
The patients who administered NSAIDs or weak opioids within 24 hours prior to subconjunctival antibiotic/antifungal injection.
Unable to cooperate with the treatment.
Pregnant women