Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients - Full Text View

Sponsored by:	Mahidol University
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00789646

Purpose

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

Condition	Intervention
Corneal Ulcer	Procedure: Lidocaine/NSS Procedure: NSS/Lidocaine

MedlinePlus related topics: Antibiotics

Drug Information available for: Lidocaine Clotrimazole Miconazole Miconazole nitrate Tioconazole Epinephrine Epinephrine bitartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients.

Further study details as provided by Mahidol University:

Primary Outcome Measures:

Numeric rating scale [ Time Frame: immediately after injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Side effects [ Time Frame: 24 hours after injection ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	32
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 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
2 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Department of Anesthesiology, Siriraj hospital ( Pramote Euasobhon )
Study ID Numbers:	SI 271/2008
Study First Received:	November 11, 2008
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00789646
Health Authority:	Thailand: Ethical Committee

Keywords provided by Mahidol University:

corneal ulcer
painless
subconjunctival injection

antibiotics
antifungal
lidocaine

Study placed in the following topic categories:

Corneal Diseases
Clotrimazole
Miconazole
Eye Diseases
Ulcer
Eye Infections

Lidocaine
Tioconazole
Keratitis
Corneal Ulcer
Epinephrine

Additional relevant MeSH terms:

Anti-Infective Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Cardiovascular Agents
Infection
Pharmacologic Actions
Anesthetics, Local

Anti-Infective Agents, Local
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Antifungal Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009