Podcast Link: SGEM83
Date: July 12th, 2014
Rebel Skeptics: Dr. Salim Rezaie is an Assistant Professor in the Department of Emergency Medicine and Internal Medicine at the University of Texas at San Antonio. You may better know him from his website REBEL EM or twitter handle @srrezaie.
Case Scenario: 47 year old man is playing Marco Polo in the pool with his daughters. He is accidentally hit in the eye and sustains a uncomplicated corneal abrasion.
Question: Is the use of topical 1.0% tetracaine for 24 hours safe and effective for the treatment of uncomplicated corneal abrasions?
Background: Corneal abrasions are very common presentations to the emergency department and very painful. We have all been warned that topical anesthetics to take home should not be given to patients with corneal injuries. The fear is that these drops could delay/decrease healing, prevent recognition of eye foreign bodies, cause keratitis or worsen corneal symptoms.
Some of this information comes from animal models or local anesthetic injected directly into the anterior chamber of the eye for cataract surgery:
- Duffin RM, Olson RJ. Tetracaine toxicity. Ann Ophthalmol. 1984;16(9)836,838.
- Judge AJ, et al. Corneal endothelial toxicity of topical anesthesia. Ophthalmology. 1997;104(9):1373–1379.
- Guzey M, et al. The effects of bupivacaine and lidocaine on the corneal endothelium when applied into the anterior chamber at the concentrations supplied commercially. Ophthalmologica. 2002;216(2):113–117.
Are the dangers of topical anesthetics for simple corneal abrasions fact or fiction?
Article: Waldman N et al. Topical Tetracaine used for 24 Hours is Safe and Rated Highly Effective by Patients for the Treatment of apain Caused by Corneal Abrasions: A Double-Blind, Randomized Clinical Trial. Acad Emerg Med 2014; 21: 374 – 382.
- Population: Patients presenting to the ED of Southland Hospital in New Zealand with Corneal Abrasions (N = 116)
- Intervention: Acetaminophen 500mg plus 1% tetracaine hydrochloride topical eye drops
- Comparison: Acetaminophen 500mg plus placebo (saline eye drops)
- Primary Outcome Safety: Repeat fluorescein/slit lamp ED examinations at 48 hours, 1-week, and 1-month telephone interviews for corneal complications
- Secondary Outcomes Pain: 100-mm VAS pain scores recorded every 2 hours while awake for 48 hours and patient perceived overall effectiveness with a numeric rating scale (NRS) of 0 – 10.
- Exclusions: Injury > 36hrs before presentation, < 18 years of age, previous eye surgery or cataracts, wear contact lenses, injury to both eyes, suffering from infectious or chemical conjunctivitis, grossly contaminated foreign bodies, suffering from an ocular infection, current herpes keratitis, allergy to tetracaine, injury requiring urgent ophthalmologic evaluation (i.e. penetrating eye injuries, large corneal abrasions, or injuries causing a disruption of vision), and unable to attend follow up at 48 hours
Authors Conclusions: ”Topical Tetracaine used for 24 hours is safe, and while there was no significant difference in patient VAS pain ratings over time, patient surveys on overall effectiveness showed that patients perceived tetracaine to be significantly more effective than saline.”
Quality Check List for Random Control Trials:
- The study population included or focused on those in the ED? Yes
- Comment: These were all patients presenting to a regional ED in New Zealand
- The patients were adequately randomized? Yes
- They used numbered sealed envelopes to randomize patients
- The randomization process was concealed? Yes
- Both the authors and the patients were blinded
- The patients were analyzed in the groups to which they were randomized? Yes
- Two arms 1% tetracaine vs. saline eye drops
- The study patients were recruited consecutively (i.e. no selection bias)? Yes
- Patient enrollment into the study could occur at any time during the day or night, 7 days a week and was dictated in part by staffing levels and demands on the department
- The patients in both groups were similar with respect to prognostic factors. Yes
- All participants (patients, clinicians, outcome assessors) were unaware of group allocation. Unsure?
- Some patients commented on the fact that the drops they were using burned like the tetracaine used in the ED at their initial evaluation. This may have unblinded some physicians and some patients
- All groups were treated equally except for the intervention. Yes
- Follow-up was complete (i.e. at least 80% for both groups). No
- Only 70% of patients had 48 hour follow-up
- All patient-important outcomes were considered. Yes
- specifically pain relief and corneal complications
- The treatment effect was large enough and precise enough to be clinically significant. No
- Twenty-three patients were removed from data analysis after 48 hour check up. This was due to retained rust rings, making the study underpowered to detect differences in corneal complications and pain scale evaluation.
- 48 hours: No statistical difference in healing identified by fluorescein uptake between the two groups
- 20 patients had persistent symptoms (10/46 tetracaine vs. 10/47 placebo)
- 1 Week: Persistent symptoms in five patients (1 tetracaine and 4 placebo)
- 1 Month: No complications reported by either group
- 48 hours: No statistical difference in healing identified by fluorescein uptake between the two groups
- No difference in 100mm VAS pain scores at an given time between the two groups
- Patient perceived effectiveness at 1 week (0- not effective and 10- completely effective)
- Statistically difference (7.7 for tetracaine vs. 3.8 for saline group)
Comments: This was the largest randomized clinical trial to date (n=116) to evaluate the use of topical anesthetics for corneal abrasions. There was no significant difference in healing between the two groups. However, only 93 patients returned for the primary outcome of follow-up at 48 hours.
Another problem was the large number of patients with retained rust rings (13-tetracaine and 10-placebo). This was unanticipated and made it challenging to analyze the data.
The study was underpowered to detect a difference in efficacy between the two groups both in 100mm-VAS pain scale. This represents a common limitations to randomized control trials. They are powered for the primary outcome not for the secondary outcome. However, their goal was to look at safety and that did not show a difference at 48hrs, 1-week or 1-month.
Patients self rated their pain about 50/100 on the VAS. Within 12 hours both groups had dropped to below 10 and at 24 hours approached zero. This speaks to the amazing healing properties of the cornea and made it nearly impossible to show a clinically significant difference between the two groups at 48 hours.
In addition, the study may have been unblinded. Tetracaine causes some local irritation and patients commented on the drops burning like the tetracaine drops used in the initial ED evaluation. A placebo drop which caused mild local irritation could have been used rather than saline. This potential unblinding may have caused the secondary outcome of patient-perceived overall effectiveness to be inflated. Researchers could have simply asked participants which group they thought they were assigned.
Finally, patient compliance with drops was not recorded. This makes it unclear whether drops were used as instructed.
This data agrees with a couple other smaller studies looking at acute corneal injuries:
- Ting et al. 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, 2(1):10-14, Jan-April, 2009
- Ball et al. Dilute proparacaine for the management of acute corneal injuries in the emergency department. CJEM 12(5):389, September 2010
Author’s conclusion compared to our conclusion: One small randomized control trial does not prove safety but it does help chip away at the myth that these drugs are toxic when used correctly.
The Bottom Line: Tetracaine appears safe for uncomplicated corneal abrasions and provides more effective pain relief than saline eye drops.
Consult Ophthalmology: Dr. Louis Probst from Michigan. He would evaluate the injury and be most concerned about infection. The next step would be to treat the patient symptomatically. This includes:
- Antibiotic eye drops (4th generation fluroquinolone plus polytrim for gram positive coverage)
- Bandage contact lens
- Non-steroidal anti-inflammatory drugs (NSAID) eye drops
These patients would then traditionally be follow-up every 24 hours by ophthalmology until the corneal defect had healed.
Case Resolution: You offer the Marco Polo playing dad some 1% tetracaine drips to use as needed every two hours for the next 24 hours. The drops sting and burn when used but make it much easier to get to sleep that night. He is seen in the emergency department for follow-up in 48 hours. The pain is gone and the abrasion has completely healed.
Clinical Application: Topical anesthetics are better at patient perceived pain relief compared to oral pain medications and saline eye drops. Evidence is not robust, but indicates when topical anesthetics are used appropriately, and for a short duration of time (24 hours) there are no corneal complications.
What do I tell my patients? You have scratched your cornea. Here are some eye drops to help treat the pain. It is safe to use for 24 hours. Your vision is important so we have arranged to see you back in the emergency department in two days. Please come back earlier if you have increased pain, decreased vision or otherwise concerned.
For more on this topic, checkout REBEL EM, where Salim discusses:
- Historical case reports, case series, and animal studies (The dogma of topical anesthetics being unsafe for corneal abrasions)
- Other trials evaluating the safety and effectiveness of topical anesthetics
- My review of the current paper we discussed plus commentary article that was released shortly after this publication
- How your pharmacist can make a 1:10 dilution of topical anesthetics
- Take home message for safety of topical anesthetics
Keener Kontest: There was no winner from last week. I guess the Swedish Skeptic, Katrin Hruska, came up with a question that was just too hard.
If you want to play the Keener Kontest this week then listen to the podcast for the question. Email me your answer at TheSGEM@gmail.com with “keener” in the subject line. The first person to correctly answer the question will receive a cool skeptical prize.
Remember to be skeptical of anything you learn,
even if you heard it on the Skeptics’ Guide to Emergency Medicine.