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Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients

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ClinicalTrials.gov Identifier: NCT00789646
Recruitment Status : Unknown
Verified June 2008 by Mahidol University.
Recruitment status was:  Enrolling by invitation
First Posted : November 13, 2008
Last Update Posted : November 13, 2008
Sponsor:
Information provided by:
Mahidol University

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
Corneal Ulcer Procedure: Lidocaine/NSS Procedure: NSS/Lidocaine

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 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 : June 2008
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Numeric rating scale [ Time Frame: immediately after injection ]

Secondary Outcome Measures :
  1. Side effects [ Time Frame: 24 hours after injection ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: Pramote Euasobhon, Department of Anesthesiology, Siriraj hospital
ClinicalTrials.gov Identifier: NCT00789646     History of Changes
Other Study ID Numbers: SI 271/2008
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: November 13, 2008
Last Verified: June 2008

Keywords provided by Mahidol University:
corneal ulcer
painless
subconjunctival injection
antibiotics
antifungal
lidocaine

Additional relevant MeSH terms:
Ulcer
Corneal Ulcer
Pathologic Processes
Eye Infections
Infection
Keratitis
Corneal Diseases
Eye Diseases
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
Anti-Bacterial Agents
Antibiotics, Antitubercular
Antifungal Agents
Miconazole
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Antitubercular Agents
14-alpha Demethylase Inhibitors