Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Short Term Topical Tetracaine is Safe and Highly Efficacious for the Treatment of Pain Caused by Corneal Abrasions

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.
 
ClinicalTrials.gov Identifier: NCT04187417
Recruitment Status : Completed
First Posted : December 5, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
INTEGRIS Southwest Medical Center

Brief Summary:
The objective of this study was to show that patients with corneal abrasions would experience more pain relief with short term topical tetracaine than placebo, have similar complication rates, and take less hydrocodone for breakthrough pain.

Condition or disease Intervention/treatment Phase
Corneal Abrasion Drug: topical tetracaine hydrochloride 1% Drug: Placebo Not Applicable

Detailed Description:
Corneal abrasions are among the most common eye-related injuries seen in the emergency department (ED). Topical anesthetic drops are routinely used prior to slit-lamp examination for diagnosis of corneal abrasions and often provide immediate pain relief. Patients are then sent home with oral analgesics and topical antibiotics. The use of topical anesthetics for outpatient treatment of corneal abrasions is discouraged by most emergency medicine textbooks due to concerns over safety. Case reports of abuse and misuse as well as animal studies have suggested that long term use of topical anesthetics may lead to rare complications. Two clinical trials showed no delayed healing after a short course of topical anesthetics following PRK surgery. Whether this could be applied to nonsurgical patients in the ED was investigated by two small clinical trials that showed similar efficacy and safety but were underpowered to prove a statistical difference. In 2014, a larger randomized trial demonstrated the safety of tetracaine for ED patients with corneal abrasions but failed to show a significant difference in patient visual analogue scale (VAS) pain ratings over time. More recently, a retrospective cohort study of 444 ED patients given tetracaine for 24 hours reported no serious complications or uncommon adverse events. If topical anesthetics could be safely prescribed for short term use in the management of corneal abrasions, it is possible that this would decrease use of systemic opioids for this purpose. The aim of this randomized, double-blind trial was to compare the effectiveness of topical tetracaine versus placebo in ED patients with corneal abrasions as measured by a reduction in the VAS score.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: sealed, numbered opaque envelopes
Primary Purpose: Treatment
Official Title: Short Term Topical Tetracaine is Safe and Highly Efficacious for the Treatment of Pain Caused by Corneal Abrasions: a Double-blind Randomized Clinical Trial
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Topical tetracaine
Topical tetracaine hydrochoride 1%
Drug: topical tetracaine hydrochloride 1%
topical ophthalmologic anesthestic

Placebo Comparator: Balanced artificial tear solution
Balanced artificial tear solution (Systane)
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Overall Visual Analog Scale score [ Time Frame: 48 hours ]
    The primary endpoint of the study was the overall post study drop Visual Analog Scale pain score measured at the patients initial follow up Emergency Department visit. Measured on a 0-10 scale with 0 meaning no pain and 10 worst pain.


Secondary Outcome Measures :
  1. Visual Analog Scale score [ Time Frame: 1 week ]
    Secondary endpoint were the average self-reported post study drop Visual Analog Scale score after each use.Measured on a 0-10 scale with 0 meaning no pain and 10 worst pain.

  2. Number of hydrocodone tablets taken [ Time Frame: 48 hours ]
  3. adverse events [ Time Frame: 1 week ]
    any adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients aged 18 years to 80 years old presenting to the ED with suspected acute corneal abrasion from mechanical trauma or removal of a foreign body by the physician were included

Exclusion Criteria:

  • Patients were excluded if they wore contact lenses, had previous corneal surgery or transplant in the affected eye, presented more than 36 hours after their injury, had a grossly contaminated foreign body or coexisting ocular infection. Additional exclusion criteria were pregnancy, retained foreign body, penetrating eye injury, immunosuppression, allergy to study medication, inability to attend follow up, inability to fluently read and speak English or Spanish, or any injury requiring urgent ophthalmologic evaluation (large or complicated abrasions with significant vision loss, corneal ulcers, corneal lacerations).
Publications:

Layout table for additonal information
Responsible Party: INTEGRIS Southwest Medical Center
ClinicalTrials.gov Identifier: NCT04187417    
Other Study ID Numbers: 14-055
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents