Review of Cornea
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Annual Pharmaceutical Issue
Pain Management in the Optometric Practice

When patients are in pain, over-the-counter or topical medications usually ease discomfort. But sometimes, an oral narcotic is necessary to reduce the pain.

By Steven Ferrucci, O.D., and Marc Bloomenstein, O.D.

Release Date: February 2012
Expiration Date: February 1, 2015

Goal Statement:

Optometrists occasionally encounter patients who require pain management. Often, these patients can be treated with over-the-counter medications or common topical ophthalmic drugs. To that end, this course reviews both topical and oral medications that are appropriate for pain relief in the optometric practice. Narcotic agents, in particular, are also discussed.

Faculty/Editorial Board:

Steven Ferrucci, O.D., and Marc Bloomenstein, O.D.

Credit Statement:

This course is COPE-approved for 2 hour of CE credit. COPE ID is 33851-PH. Please check your state licensing board to see if this approval counts toward your CE requirement for relicensure.

Joint-Sponsorship Statement:

This continuing education course is joint-sponsored by the Pennsylvania College of Optometry.

Disclosure Statement:

Dr. Ferrucci is on the advisory board for Arctic DX, Alcon, Allergan and Reichert. Dr. Bloomenstein is a consultant and on the speakers’ bureau for Abbott Medical Optics, Allergan, Alcon Laboratories, Bausch + Lomb, Ista Pharmaceuticals, RPS and Reichert, and on the speakers’ bureau for Merck and Odyssey Labs. The authors have no financial interest in any products aside from their consulting agreements.


As optometrists, we will occasionally come across patients who require pain management. Although the need for pain relief is most often acute and lasts perhaps just 24 to 48 hours or less, patients certainly appreciate the cessation of discomfort. Incidences that necessitate pain control include corneal abrasions, foreign bodies, trauma, or after refractive or cataract surgery. Pain may also be associated with inflammation— most notably intraocular pain, such as that associated with episcleritis or preseptal cellulitis. In certain circumstances, a bandage contact lens, ophthalmic ointments or pressure patching may be enough to aid in patient comfort and augment the healing process.

More often, topical agents, such as non-steroidal agents (NSAIDs), with or without cycloplegics may be adequate. Yet in severe cases, an oral agent in the form of a narcotic is needed to reduce the pain.

This article reviews the various agents used for pain relief in the optometric practice, as well as some pearls and pitfalls to treating pain.

Know What You Are Treating

Before initiating any treatment for pain management, you need to do a thorough medical history that particularly focuses on allergies and current medications. Interactions of drugs and allergic response can aggravate an already unfortunate problem. Along these same lines, determine if your patient has any medical issues that may limit your ability to prescribe the appropriate treatment or recommended dose (e.g., issues with metabolizing or clearing the meds).

It is imperative to determine the true cause of the pain, and treat it accordingly. Otherwise, all we are doing is masking the pain, without truly remedying the problem. The pain may be something that your patient has experienced before, so during your history remember the mnemonic FOLDAR: Frequency, Onset, Location, Duration, Association and Relief. Asking these questions can help to localize the discomfort or give you a good indication of the treatment options already attempted to placate the pain.

img 1The nature of the pain, as well as its severity, should also be assessed. Gauging the pain is helpful and can be accomplished by subjectively asking the patient to assess their pain on a scale from 0 (“no pain”) to 10 (“the worst pain ever”). While each person has a different threshold of pain, it is important to make sure that as we treat the pain and the underlying condition, the patient’s relative discomfort is decreasing, not increasing. Although the irritation may sometimes get worse before it gets better, if the pain is increasing with treatment then we have to assume we either misdiagnosed or mistreated the condition. This indicates that we need to change the treatment protocol.

Topical Meds

The first line of pain management often can be initiated with a topical medication. The advantage with topical formulations—aside from the medication reaching the superficial tissue (episclera, cornea, etc.) in higher concentrations—is that there are fewer side effects and they are more easily manageable for the patient.

Ideally, we could simply treat ocular pain with 0.5% proparacaine to deaden the cornea-rich nerves and improve the surface pain. However, the toxicity and potential abuse of this class of medication prohibits that practice, and frankly is not the standard of care.

Yet, there has been a movement of late, spurred by the discomfort induced by surface ablation surgeries, to use a diluted proparacaine for the analgesic effects. Investigators in Canada conducted a small, randomized, masked study of adults with corneal injuries.1 Participants were treated with either 0.05% proparacaine or an artificial tear placebo. The proparacaine arm had a significant improvement in pain reduction. The investigators found no ocular complications or signs of delayed healing in either group, and concluded that the use of diluted proparacaine may be an efficacious analgesic for these acute corneal injuries.

(As described in this study, the proparacaine was diluted by a factor of 10, and this can be accomplished by a pharmacy.1 However, similar results can be achieved by using a 3mL sample of artificial tears diluted with two to three drops of proparacaine 0.5% solution.)

When this diluted drug is put into practice, patients who receive it should be cautioned about the significant potential for abuse and potential cornea-related complications. Perhaps even educate the patient to “not use” these drops— unless absolutely necessary. Just knowing that they have it available to decrease or terminate the acute pain may provide a psychological benefit for patients to get them through the worst of the pain, without having to actually use it. Be sure to ask your patients to bring back the diluted bottle at a follow-up appointment (you may be surprised to see that the bottle is still full), and discard the remaining drops upon completion of the treatment.

• Artificial tears. Lubricating the ocular surface helps reduce discomfort that may be a concomitant reaction to the inflamed tissue. Moreover, certain treatment options, such as topical antivirals, may induce some irritation or dryness that only a lubricating drop can alleviate. So, the use of artificial tears can provide a minor sense of relief.

• NSAIDs. The primary mechanism of action responsible for nonsteroidal anti-inflammatory drugs (NSAID) and their analgesic effect is the inhibition of prostaglandin synthesis by competitive blocking of cyclooxygenase (COX).2 COX is an enzyme that is responsible for the production of inflammatory mediators, such as prostaglandins. The use of a topical NSAID, frequently used in surgery patients, can reduce inflammation, maintain pupil dilation and induce an analgesic effect. This triad is most useful in the successful management of ocular pain.

Because this class does not work on the same enzymes as steroids, there is little concern of any sight threatening long-term complications. Although some cases of delayed wound healing and corneal melts have been reported, the use of an NSAID for long-term pain management is beneficial; also, the contributing factors to these corneal complications may be overuse of the medication or concomitant systemic factors, such as diabetes.3 Patients who report low-grade discomfort, ocular or periocular allergy or medicamentosa secondary to other medications, as well as acute pain, can appreciate the analgesic effects.

Unfortunately, the earlier NSAID formulations sting or burn upon instillation, so many doctors (and patients) avoid this line of treatment. However, one strategy to help patients with the burn upon instillation is to keep the drop in the refrigerator. When the drop is instilled, it reduces the burning sensation and provides pain relief like a cold compress.

For many years, the stalwart NSAIDs have been Voltaren (diclofenac 0.1%, Novartis) and Acular LS (ketorolac tromethamine 0.4%, Allergan). Although both show a decrease in corneal sensitivity, these drops require a q.i.d. dosage and have the added deficiency of inducing that uncomfortable sting. Because we want to ameliorate the pain, not add to it, these side effects may be a deterrent.

The newer ophthalmic NSAIDs do not carry the same stinging side effect and are more readily used for pain relief.

Acuvail (ketorolac tromethamine 0.45%, Allergan) is the latest NSAID to be approved by the FDA. This formulation is preservative free and is supplied in individual ampules that are useful for the transient nature of this treatment. This NSAID is dosed b.i.d. and is indicated for perioperative use one day prior to cataract surgery. There has been some concern that this drop is cost prohibitive. But for patients who may have recurring pain issues, such as recurrent corneal erosions, the availability of a b.i.d.-dosed analgesic that is preservative free may justify the price.

img 2Nevanac (nepafenac 0.1%, Alcon) is a unique NSAID that is a prodrug. The suspension first touches the cornea as nepafenac, which delivers the analgesic to the surface without discomfort associated with other NSAIDs. As it penetrates the intraocular tissues, an enzyme converts nepafenac molecules into the COX-inhibitor amfenac.4 Alcon reports that this mechanism of action gives Nevanac a target-specific activity, maximizing the efficacy at the intended ocular sites where pain and inflammation reside.

Bromday (bromfenac 0.09%, Ista) is a once-a-day selective NSAID that is indicated for the treatment of pain and ocular inflammation following cataract surgery. Ista reports that this drop is the most selective and potent COX-2 inhibitor. The q.d. dosing may be the perfect solution for the acute pain that your patients are experiencing and, from a prophylactic aspect, may increase patient compliance.

All NSAIDs have the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents. So, use caution when treating individuals who have previously exhibited sensitivities to these drugs. Moreover, with the potential for corneal toxicity and melting issues, these drops should be used with precaution when there is a corneal breach. If there is an epithelial compromise that lasts longer than a week of treatment, cease the use of the NSAID.

The NSAIDs are specifically indicated for the treatment of pain and inflammation in and around cataract surgery; thus, alternative use would be considered an off-label treatment. This may become necessary to explain to the pharmacy or the patient.

• Cylcoplegics. Often, ocular pain is related to an intraocular inflammatory component, or a superficial corneal problem that translates internally. An example is a patient with a foreign body on the epithelium that also induces an iritis or internal inflammation. In these instances, the use of a cycloplegic agent can help to reduce the excruciating pain your patient is experiencing. Depending on the duration and extent of cycloplegia and mydriasis desired (as well as taking into account that heavily pigmented irises may require higher strengths), the exact concentration, dosage and type of cycloplegic should be determined on a per-case basis.

Cycloplegics block acetylcholine, a stimulatory neurotransmitter of the autonomic nervous system. Because acetylcholine induces contraction of the iris and ciliary body, the cycloplegic does the exact opposite by temporarily inducing pupil dilation and paralysis of the ciliary body. The relaxation of the ciliary spasm induces a reduction in the pain and stabilizes the bloodaqueous barrier, which reduces the anterior chamber inflammation.

Atropine, derived from the atropa belladonna (deadly nightshade) plant, is the most potent cycloplegic agent available, with a duration lasting up to 12 days. Atropine is available in 0.5%, 1% and 2% ophthalmic solutions and a 1% ophthalmic ointment, with a recommended dosage of b.i.d. to t.i.d. Long-lasting cycloplegia may be necessary in extreme cases of iritis, and using such a strong cycloplegic will also help prevent posterior synechiae formation.

Scopolamine is available in 0.25% ophthalmic solution and is dosed b.i.d. The choice of scopolamine vs. that of the more potent atropine should be based on the severity of the patient’s inflammation.

Homatropine, another cycloplegic agent, is available in 2% and 5% concentrations. With only about 10% the potency of atropine, this is a very effective drop for those acute inflammatory pain reactions. It tends to have a cycloplegic recovery in one to three days after use.

When a patient presents with a traumatic corneal injury, such as an abrasion, consider the use of cyclopentolate instead. Cyclopentolate is available in 0.5%, 1% or 2% concentrations. Because this drop is short-acting, its role is to hold the potential inflammatory mediators in the blood vessels and not release them into the anterior chamber. So, if you have no other drops at hand, cyclopentolate is an acceptable Band-Aid until you can use a stronger cycloplegic.

• Topical steroids. The use of steroids as adjunctive pain modulators is limited to the cessation of the inflammation in the eye. As stated earlier, it is important to find cause of the discomfort and treat it accordingly. But, whether that cause is secondary or idiopathic, steroids can help treat the underlying inflammation that is producing the pain.

Steroids have a high side-effect profile and should be limited to short-term treatment options. Patients need to be followed more closely to measure the intraocular pressure (IOP), which may be raised secondary to the medication. Although some data suggest that selective steroids, such as ester-based steroids, have a lower prevalence of IOP spiking, a good rule of thumb is to measure the IOP bi-weekly every time a steroid is prescribed, regardless of the dosing and concentration. There are, however, some differences in ophthalmic steroids, and making a decision of which would be the most effective for the patient’s inflammatory pain should be taken into account.

Loteprednol etabonate is an ester-based steroid marketed by Bausch + Lomb in two concentrations of topical formulations: Alrex (loteprednol etabonate 0.2%) and Lotemax (loteprednol etabonate 0.5%), as well as an ointment (loteprednol etabonate 0.5%).

Loteprednol has proven effective in the reduction of ocular inflammation. Subsequently, in a post hoc analysis of data collected from two published pivotal clinical trials, Lotemax provided statistically significant relief of postoperative pain following cataract surgery.5 This translates into superior use for pain management in your patients with mild inflammatory conditions.

img3Durezol (difluprednate 0.05% emulsion, Alcon) is the first and only FDA-approved steroid indicated for the treatment of pain following cataract surgery. The recommended dosage is one drop, b.i.d to q.i.d., postoperatively.

Durezol has been shown to be as effective q.i.d. as prednisolone acetate administered eight times a day in resolving inflammation and pain associated with endogenous anterior uveitis.6 This suggests that Durezol can be effectively used at a lower dosage than other steroids.

Oral Meds

Before initiating any oral pain management, a more thorough medical history of the patient is warranted. Be sure to ask about alcohol use, antidepressant use, smoking, history of stomach ulcers and pregnancy in appropriate patients, because these may be contraindications for certain treatments. Also, be sure to ask about any current medications as well as over-the-counter (OTC) preparations that the patient may be taking—especially warfarin, digoxin and antidepressants, because these have interactions with many other medications. Additionally, check the patient’s medical history for kidney or liver disease, as medications may be metabolized and cleared less quickly with liver or renal status. Lastly, make sure to inquire about a history of previous allergy to any medications, especially aspirin, and document accordingly.

In general, start with the simplest, most cost-effective treatment and work up, depending on the patient’s level of pain, symptoms, etc. So, OTC agents are often the first line treatment for mild to moderate pain. Yet, caution your patients about the notion of “more is better,” because the side effects of these medications, although OTC, may be significant.

• Over-the-counter options. There are several OTC preparations that can be recommended for pain management.

Aspirin (acetylsalicylic acid) is available in a variety of forms and is very inexpensive. However, it is not great for pain relief, and a low dose (81mg/day) is generally used more for stroke, myocardial infarction and blood clot prevention than for true pain relief. Dosage for analgesia is typically 650mg to 975mg every four hours. It is contraindicated in patients with a history of aspirin allergy, bleeding ulcers or other bleeding disorders as well as in patients who consume more than three alcoholic beverages a day, or are pregnant as it is category D medication (positive evidence of risk). Another consideration: Avoid aspirin in patients less than 18 years of age or with viral illnesses, such as the flu or chicken pox, due to concerns of Reye’s syndrome.

img4Acetaminophen is also available in many preparations, such as brand-name Tylenol (McNeil) or as a generic. It is much better at relieving pain than aspirin, but does not have any platelet or antiinflammatory properties like aspirin or NSAIDs. The new recommended dosage is 650mg to 975mg every four hours for pain relief, with a maximum daily dose of 3,000mg to prevent liver toxicity. It is safe to use during pregnancy, with bleeding disorders, and in children with viral infections because there is no danger of Reye’s syndrome, as with aspirin. It is contraindicated in patients with liver disease, alcoholism or a history of acetaminophen hypersensitivity.

Over-the-counter NSAIDs are readily available as well, and are effective for mild to moderate pain relief. They have the added benefit of anti-inflammatory control; due to this dual effect, they are often a good choice for a patient with ocular pain from iritis, for example.

Ibuprofen is available OTC as brand-name Motrin (McNeil) or as ageneric. It can be dosed from 200mg to 800mg every four hours, with a maximum daily dose of 2,400 mg. The side effects of ibuprofen—stomach upset and GI toxicity—can be lessened if the daily dose is kept under 1,600mg per day.

Naproxen sodium is another OTC NSAID option, available as Aleve (Bayer Healthcare) and as a generic. Dosage is 220mg every eight to 12 hours, with a maximum dose of 1,500mg per day. Many doctors recommend two pills as a loading dose and then one pill every eight to 12 hours thereafter, with no more than three pills in a 24-hour period.

Contraindications to all the NSAIDs include GI bleeding, avid alcohol use and pregnancy (because it is category C, an unknown risk). Also, they should be avoided in patients with a known hypersensitivity to NSAIDs and used in caution with patients with an aspirin allergy, as there may be a crossover effect.

There are also many NSAIDs available by prescription only, such as naproxen. Its recommended dose is 500mg initially, then 250mg every six to eight hours thereafter for reduction of pain and inflammation.

Indomethacin is also a commonly used NSAID for the pain, tenderness, swelling and stiffness caused by arthritis, but it has no indication for general pain. However, it is used frequently in eye care for the treatment of scleritis, typically 25mg to 50mg three times a day.

• Narcotics. When greater pain relief is needed, the next step is a narcotic. Narcotics should be used judiciously; but when used appropriately, they are great options for patients in moderate to severe pain. Rules governing prescribing of narcotics by optometrists vary state by state, so be familiar with your particular state’s rules. As an example, an optometrist in California can prescribe Schedule III narcotics if there is a direct indication for ocular pain. (See “States That Permit Optometrists to Prescribe Controlled [Narcotic] Legend Drugs, below”)

tbl1
Source: AOA State Government Relations Center
Last Revised April 28, 2011
1. Reserved.
2. Treatment for ocular pain and inflammation.
3. Treatment with only those oral analgesic drugs included in
the formulary.
4. Therapeutically-certified ODs may utilize any pharmaceutical
agent rational to the treatment of eye disease.
5. Treatment with controlled analgesic drugs over 72 hours may
not be done without consultation with the patient’s physician.
6. Within the Schedule II category - topical only is permitted
(this would be the one controlled drug available for diagnostic
purposes)
7. Within the Schedule III category - no agents containing dihydrocodeinone
(“hydrocodone”),
other Schedule III drugs limited
to Rx not to exceed 96 hours.
8. Prescriptions limited to dosages for no more than 72 hours.
9. Treatment with acetaminophen plus 30mg of codeine only.
10. Prescription of analgesics for a duration of no more than
3 days.
11. Compounds containing codeine or hydrocodone only.
12. Treatment with Schedule III analgesics longer than 7 days
requires consultation with an MD.
13. Plus may prescribe dihydrocodeinone combination drugs, no matter what class they are scheduled in.
14. Prescription for controlled narcotic substance may not be for
more than 7 days for a single condition, trauma, episode.
15. Rx of narcotic for 48 hours only. May be followed with one
additional 48 hour Rx if warranted by follow-up exam.
16. Prescriptions limited to analgesics in dosages for no more than 72 hours.
17. Prescriptions limited to 4 days quantity.
18. Prescriptions limited to one 5 day supply of analgesics in
Schedules III, IV, and V.
State optometry acts specifically prohibiting optometrists from
prescribing controlled (narcotic) legend drugs: Delaware, Hawaii,
Indiana, and Massachusetts (when referring to this list of states
which specifically prohibit the prescription of controlled drugs,
remember that other states not listed here authorizing “topical
agents only” or “specific categories only” could essentially prohibit
the use of controlled narcotic drugs as well.)

 

Codeine is a very useful narcotic for mild to moderate pain relief. It is not typically prescribed by itself, but rather in conjunction with either aspirin or Tylenol. When combined with aspirin, it has the added benefit of inflammatory control. However, when combined with Tylenol, the codeine and the Tylenol work on separate areas of the central nervous system to produce a synergistic effect and very good pain relief.

The most common form of codeine is Tylenol #3, which has 30mg of codeine and 300mg of acetaminophen. (Tylenol #1 has 15mg codeine and Tylenol #4 has 60mg of codeine—each with the same amount of acetaminophen, 300mg). Its recommended dose is one to two tablets every four to six hours, with a maximum daily dose of 360mg codeine and 4,000mg Tylenol.

Empirin (Glaxo Wellcome) with codeine #3 is 30mg of codeine combined with 325mg of aspirin. Empirin with codeine #4 is 60mg codeine with 325mg aspirin. Recommended dose of either is one tablet every four to six hours, with a maximum daily dose of 360mg of codeine.

Codeine can be fairly sedating, so advise caution, especially if a patient has not used it previously. Also, GI disturbances are common, with constipation being the most reported side effect.

Hydrocodone is about six times as potent as codeine, and may cause less constipation and sedation than codeine. Like codeine, hydrocodone is a Schedule III drug and is commonly co-formulated with either Tylenol or ibuprofen. The most commonly prescribed form is Vicodin (Abbott Laboratories), which is 5mg hydrocodone with 500mg acetaminophen. Recommended dose is one to two tabs every four to six hours, with a maximum dose of eight tablets per day, or 4,000 mg acetaminophen.

img5It is also available as Vicodin ES (extra strength), which is 7.5mg hydrocodone and 750mg acetaminophen, with a maximum dose of five tablets per day. Vicodin HP (high potency) is 10mg hydrocodone with 660mg acetaminophen, with a maximum of six tablets per day.

Hydrocodone also can be combined with ibuprofen for added inflammatory control in the form of Vicoprofen (Abbott Laboratories), which is 7.5mg hydrocodone and 200mg ibuprofen, given one to two tabs every four to six hours, with a maximum dose of five tablets per day.

Tramadol is a synthetic analogue of codeine; but it is non-narcotic, so it is not DEA classified. Tramadol has similar potency as Tylenol #3, but its abuse and addiction potential is very low. It has minimal side effects, including dizziness, headaches, nausea, vomiting and drowsiness. However, it has many interactions with other drugs, including tegretol, digoxin, warfarin and others. Also, it should be avoided in patients with a history of seizures. Recommended dose is 50mg to 100mg every four to six hours with a maximum dose of 400mg a day. (Individuals 75 years and older should be limited to 300mg a day.) When combined with acetaminophen, it is called Ultacet (37.5 tramadol/325mg acetaminophen, Ortho-McNeil-Janssen) with a recommended dose of one to two tablets every four to five hours.

Side effects of these narcotics include drowsiness, respiratory depression, liver toxicity, renal failure and urinary retention, nausea and vomiting, and abuse or addiction potential. However, when used appropriately for the short term, many of these side effects are never realized. Further, addiction and abuse potential is very low when used for such a short period of time.

img6The treatment of pain is not limited to on-label indications, and finding the right dosing should be individualized. A realistic goal is to provide relief of the discomfort the fastest way possible with the least amount of side effects. Bear in mind that there is sometimes a disconnect between the severity of the pain and the physical signs. Yet, we as clinicians need to balance both when helping patients get back to status quo.

Looking for a topical solution is optimal and yet is not always possible. Combining treatments may be the best solution; so don’t be afraid to write multiple prescriptions to alleviate your patient’s discomfort.

At the end of the day, your patient just wants to feel better.

Dr. Ferrucci is chief of optometry and residency director at the Sepulveda VA Ambulatory Care Center and Nursing Home in North Hills, Calif. He is also an associate professor at Southern California College of Optometry. Dr. Bloomenstein is the director of optometric services at Schwartz Laser Eye Center in Scottsdale, Ariz. He is the immediate past president of the Optometric Council on Refractive Technology.

References

  1. Ball IM, Seabrook J, Desai N, et al. Dilute proparacaine for the management of acute corneal injuries in the emergency department. CJEM. 2010 Sep;12(5):389-96.
  2. Vane JR. Inhibition of prostaglandin synthesis as a mechanism of action for aspirin-like drugs. Nat New Biol. 1971 Jun 23;231(25):2325.
  3. Congdon NG, Schein OD, von Kulajta P, et al. Corneal complications associated with topical ophthalmic use of nonsteroidal antiinflammatory drugs. J Cataract Refract Surg. 2001 Apr;27(4):622-31.
  4. Gamache DA, Graff G, Brady MT, et al. Nepafenac, a unique nonsteroidal prodrug with potential utility in the treatment of trauma-induced ocular inflammation: I. Assessment of anti-inflammatory efficacy. Inflammation. 2000 Aug;24(4):357-70.
  5. Comstock TL, Paterno MR, Singh A, et al. Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery. Clin Ophthalmol. 2011;5:177-86.
  6. Foster CS, Davanzo R, Flynn TE, et al. Durezol (Difluprednate Ophthalmic Emulsion 0.05%) compared with Pred Forte 1% ophthalmic suspension in the treatment of endogenous anterior uveitis. J Ocul Pharmacol Ther. 2010 Oct;26(5):475-83.

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