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Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00789646
First received: November 11, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients.

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

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

No publications provided

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

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

Additional relevant MeSH terms:
Corneal Ulcer
Ulcer
Eye Infections
Infection
Keratitis
Corneal Diseases
Eye Diseases
Pathologic Processes
Anti-Bacterial Agents
Antifungal Agents
Clotrimazole
Miconazole
Lidocaine
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013