Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients

NCT ID: NCT00789646

Last Updated: 2019-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-06-30

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.

Conditions

Corneal Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NSS/Lidocaine

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

Group Type: EXPERIMENTAL

NSS/Lidocaine

Intervention Type: PROCEDURE

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

Lidocaine/NSS

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

Group Type: EXPERIMENTAL

Lidocaine/NSS

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

1. corneal epithelial defect with stromal infiltration

2. reaction in anterior chamber

3. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Pramote Euasobhon

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SI 271/2008

Identifier Type: -

Identifier Source: org_study_id