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

Primary Purpose

Corneal Abrasion

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
topical tetracaine hydrochloride 1%
Placebo
Sponsored by
INTEGRIS Southwest Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Abrasion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Topical tetracaine

    Balanced artificial tear solution

    Arm Description

    Topical tetracaine hydrochoride 1%

    Balanced artificial tear solution (Systane)

    Outcomes

    Primary Outcome Measures

    Overall Visual Analog Scale score
    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

    Visual Analog Scale score
    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.
    Number of hydrocodone tablets taken
    adverse events
    any adverse events

    Full Information

    First Posted
    November 27, 2019
    Last Updated
    December 4, 2019
    Sponsor
    INTEGRIS Southwest Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04187417
    Brief Title
    Short Term Topical Tetracaine is Safe and Highly Efficacious for the Treatment of Pain Caused by Corneal Abrasions
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    September 30, 2017 (Actual)
    Study Completion Date
    September 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    INTEGRIS Southwest Medical Center

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Corneal Abrasion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    sealed, numbered opaque envelopes
    Allocation
    Randomized
    Enrollment
    118 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Topical tetracaine
    Arm Type
    Experimental
    Arm Description
    Topical tetracaine hydrochoride 1%
    Arm Title
    Balanced artificial tear solution
    Arm Type
    Placebo Comparator
    Arm Description
    Balanced artificial tear solution (Systane)
    Intervention Type
    Drug
    Intervention Name(s)
    topical tetracaine hydrochloride 1%
    Intervention Description
    topical ophthalmologic anesthestic
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Overall Visual Analog Scale score
    Description
    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.
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    Visual Analog Scale score
    Description
    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.
    Time Frame
    1 week
    Title
    Number of hydrocodone tablets taken
    Time Frame
    48 hours
    Title
    adverse events
    Description
    any adverse events
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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).

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28483289
    Citation
    Waldman N, Winrow B, Densie I, Gray A, McMaster S, Giddings G, Meanley J. An Observational Study to Determine Whether Routinely Sending Patients Home With a 24-Hour Supply of Topical Tetracaine From the Emergency Department for Simple Corneal Abrasion Pain Is Potentially Safe. Ann Emerg Med. 2018 Jun;71(6):767-778. doi: 10.1016/j.annemergmed.2017.02.016. Epub 2017 May 5.
    Results Reference
    background
    PubMed Identifier
    24730399
    Citation
    Waldman N, Densie IK, Herbison P. Topical tetracaine used for 24 hours is safe and rated highly effective by patients for the treatment of pain caused by corneal abrasions: a double-blind, randomized clinical trial. Acad Emerg Med. 2014 Apr;21(4):374-82. doi: 10.1111/acem.12346.
    Results Reference
    background
    PubMed Identifier
    20880433
    Citation
    Ball IM, Seabrook J, Desai N, Allen L, Anderson S. Dilute proparacaine for the management of acute corneal injuries in the emergency department. CJEM. 2010 Sep;12(5):389-96. doi: 10.1017/s1481803500012537.
    Results Reference
    background
    PubMed Identifier
    19561949
    Citation
    Ting JY, Barns KJ, Holmes JL. Management of Ocular Trauma in Emergency (MOTE) Trial: A pilot randomized double-blinded trial comparing topical amethocaine with saline in the outpatient management of corneal trauma. J Emerg Trauma Shock. 2009 Jan;2(1):10-4. doi: 10.4103/0974-2700.44676.
    Results Reference
    background
    PubMed Identifier
    9457454
    Citation
    Verma S, Corbett MC, Patmore A, Heacock G, Marshall J. A comparative study of the duration and efficacy of tetracaine 1% and bupivacaine 0.75% in controlling pain following photorefractive keratectomy (PRK). Eur J Ophthalmol. 1997 Oct-Dec;7(4):327-33. doi: 10.1177/112067219700700404.
    Results Reference
    background
    PubMed Identifier
    9098296
    Citation
    Verma S, Corbett MC, Marshall J. A prospective, randomized, double-masked trial to evaluate the role of topical anesthetics in controlling pain after photorefractive keratectomy. Ophthalmology. 1995 Dec;102(12):1918-24. doi: 10.1016/s0161-6420(95)30775-0.
    Results Reference
    background
    PubMed Identifier
    16783149
    Citation
    Chang YS, Tseng SY, Tseng SH, Wu CL. Cytotoxicity of lidocaine or bupivacaine on corneal endothelial cells in a rabbit model. Cornea. 2006 Jun;25(5):590-6. doi: 10.1097/01.ico.0000220775.93852.02.
    Results Reference
    background
    PubMed Identifier
    7925683
    Citation
    Grant RL, Acosta D. Comparative toxicity of tetracaine, proparacaine and cocaine evaluated with primary cultures of rabbit corneal epithelial cells. Exp Eye Res. 1994 Apr;58(4):469-78. doi: 10.1006/exer.1994.1040.
    Results Reference
    background
    PubMed Identifier
    1399407
    Citation
    Bisla K, Tanelian DL. Concentration-dependent effects of lidocaine on corneal epithelial wound healing. Invest Ophthalmol Vis Sci. 1992 Oct;33(11):3029-33.
    Results Reference
    background
    PubMed Identifier
    2625618
    Citation
    Higbee RG, Hazlett LD. Topical ocular anesthetics affect epithelial cytoskeletal proteins of wounded cornea. J Ocul Pharmacol. 1989 Fall;5(3):241-53. doi: 10.1089/jop.1989.5.241.
    Results Reference
    background
    PubMed Identifier
    2402423
    Citation
    Rosenwasser GO, Holland S, Pflugfelder SC, Lugo M, Heidemann DG, Culbertson WW, Kattan H. Topical anesthetic abuse. Ophthalmology. 1990 Aug;97(8):967-72. doi: 10.1016/s0161-6420(90)32458-2.
    Results Reference
    background
    PubMed Identifier
    2666331
    Citation
    Rosenwasser GO. Complications of topical ocular anesthetics. Int Ophthalmol Clin. 1989 Fall;29(3):153-8. doi: 10.1097/00004397-198902930-00005. No abstract available.
    Results Reference
    background
    PubMed Identifier
    629912
    Citation
    Henkes HE, Waubke TN. Keratitis from abuse of corneal anaesthetics. Br J Ophthalmol. 1978 Jan;62(1):62-5. doi: 10.1136/bjo.62.1.62.
    Results Reference
    background
    PubMed Identifier
    5472832
    Citation
    Willis WE, Laibson PR. Corneal complications of topical anesthetic abuse. Can J Ophthalmol. 1970 Jul;5(3):239-43. No abstract available.
    Results Reference
    background
    PubMed Identifier
    26319343
    Citation
    Ahmed F, House RJ, Feldman BH. Corneal Abrasions and Corneal Foreign Bodies. Prim Care. 2015 Sep;42(3):363-75. doi: 10.1016/j.pop.2015.05.004. Epub 2015 Jul 31.
    Results Reference
    background
    PubMed Identifier
    33121832
    Citation
    Shipman S, Painter K, Keuchel M, Bogie C. Short-Term Topical Tetracaine Is Highly Efficacious for the Treatment of Pain Caused by Corneal Abrasions: A Double-Blind, Randomized Clinical Trial. Ann Emerg Med. 2021 Mar;77(3):338-344. doi: 10.1016/j.annemergmed.2020.08.036. Epub 2020 Oct 27.
    Results Reference
    derived

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