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
About this trial
This is an interventional treatment trial for Corneal Abrasion
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).
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
NCT ID
NCT04187417
First Posted
November 27, 2019
Last Updated
December 4, 2019
Sponsor
INTEGRIS Southwest Medical Center
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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Short Term Topical Tetracaine is Safe and Highly Efficacious for the Treatment of Pain Caused by Corneal Abrasions
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