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Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Mahidol University.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00789646
First Posted: November 13, 2008
Last Update Posted: November 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mahidol University
  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

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Mahidol University:

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

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

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

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Pramote Euasobhon, Department of Anesthesiology, Siriraj hospital
ClinicalTrials.gov Identifier: NCT00789646     History of Changes
Other Study ID Numbers: SI 271/2008
First Submitted: November 11, 2008
First Posted: November 13, 2008
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