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

NCT ID: NCT04187417

Last Updated: 2019-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Corneal Abrasion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
sealed, numbered opaque envelopes

Study Groups

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Topical tetracaine

Topical tetracaine hydrochoride 1%

Group Type EXPERIMENTAL

topical tetracaine hydrochloride 1%

Intervention Type DRUG

topical ophthalmologic anesthestic

Balanced artificial tear solution

Balanced artificial tear solution (Systane)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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topical tetracaine hydrochloride 1%

topical ophthalmologic anesthestic

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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INTEGRIS Southwest Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type BACKGROUND
PMID: 28483289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24730399 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20880433 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19561949 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9457454 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9098296 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16783149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7925683 (View on PubMed)

Bisla K, Tanelian DL. Concentration-dependent effects of lidocaine on corneal epithelial wound healing. Invest Ophthalmol Vis Sci. 1992 Oct;33(11):3029-33.

Reference Type BACKGROUND
PMID: 1399407 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2625618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2402423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2666331 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 629912 (View on PubMed)

Willis WE, Laibson PR. Corneal complications of topical anesthetic abuse. Can J Ophthalmol. 1970 Jul;5(3):239-43. No abstract available.

Reference Type BACKGROUND
PMID: 5472832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26319343 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33121832 (View on PubMed)

Other Identifiers

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14-055

Identifier Type: -

Identifier Source: org_study_id