Since the MKO Melt became available last spring, our practice has administered this sublingual pill, which delivers anesthetic medications, to more than 2,500 patients. Our transition away from the placement of a needle in the arm (IV) to a pill under the tongue has been relatively quick for a few reasons — most importantly because our patients prefer it and it has proven itself to be safe.

During this time, we have learned some important points about the Melt, mainly regarding patient selection and time of administration. And we have incorporated those points, knowing, for example, that more nervous people might prefer an IV or that those who regularly drink alcohol or take illicit drugs will need a larger dose of it.

What follows is a brief summary of our experiences with the Melt, and a discussion of what we have learned about it.

EVOLUTION

Cataract surgery continues to evolve. After safety was mastered, surgeons, and industry, made improved refractive outcomes their goal. Now, the focus is on improving a patient’s overall experience. For many patients, a major source of anxiety is administration of the intravenous line. Some patients have difficulty with administration of the IV due to poor accessibility of their veins. Many patients associate anticipation of the IV with pain, or the perception of it. These patients consider the pain they associate with the IV needle stick likely worse than the pain experienced during cataract surgery.

The MKO Melt has helped these patients. The Melt is an IV-free conscious sedation compounded formulation. It consists of 3 mg of midazolam (Versed, Roche), 25 mg of ketamine HCl, and 2 mg of ondansetron (Zofran, GSK). It is delivered as a single-use prescription for each patient. Initially lemon flavored, the Melt eventually becomes slightly bitter.

During the development of this product, midazolam was chosen as one of the primary components since it is frequently used during cataract surgery. It provides a good anxiolytic effect with a rapid on and off effect. Ketamine delivers analgesia with a mild amount of euphoria. It also provides for a “ketamine stare,” enabling patients to look at the microscope light rather than away from it.

The dosage of ketamine in the melt is much less than what is typically administered IV, resulting in fewer untoward side effects.

TRANSITIONS AND SURVEYS

When we first transitioned over to the MKO Melt, we conducted a small, 24-patient survey (unpublished) so those patients could discuss their experience with this therapy. These patients’ views were important, as they had had surgery on both eyes: For the first eye, they received an IV anesthetic and for their second surgery, the sublingual pill. In general, most patients, during their second eye surgery, are more aware and experience more discomfort than with the cataract surgery in their first eye.

We found that 75% of patients preferred the MKO Melt, which was surprising to us for the reasons mentioned. Patients felt that the Melt was equivalent to having an IV, and they felt that it was less invasive than the IV.

Subsequently, we conducted an additional 300-patient (unpublished) survey. We found that 90% of patients felt comfortable and did not experience any unexpected side effects. Eighty-five percent of patients felt that their perception during surgery was “just right” rather than being “too awake or too sleepy.”

OBSERVATIONS

Typically, most patients receive one to two Melts under the tongue. In our experience, we have found that the dosage depends primarily based on age rather than weight. Though initially we thought that weight would be an important dosage determinant, we have instead found that a younger, thin person will need more Melt than an older and overweight individual.

Generally speaking, a person between 60 and 65 years of age will receive two pills; 1.5 melts for patients between 65 to 70, one melt for patients between 70 to 80, and 0.5 melt for patients greater than 80.

The timing of administration is extremely important. The melts take approximately two to five minutes to dissolve. Patients often report feeling some type of effect within 5 to 10 minutes, with the maximal effect occurring in about 30 to 40 minutes. Initially, we were administering the Melts right before the cataract surgery, but that was too late. Patients would not have enough effect in the operating room and would end up with a prolonged stay in the recovery room. By administering the sublingual pills about half an hour prior to the procedure, the patient experiences the maximum effect in the OR during surgery, with a shortened recovery time.

Certain situations will result in an increased dose, such as with extremely nervous patients or patients who regularly use alcohol, illicit drugs or benzodiazepines.

We give a decreased dose to patients who appear very frail or have poor general health. Sometimes, we just use an IV for these patients. If we desire more control, such as for a very elderly individual, we will administer an IV. If someone looks like an outlier, we don’t take the chance. If a patient is not as medically stable, we will place an IV to have better control since we can titrate the medication.

Any individual, including the preoperative nurses and anesthetist, has veto power to administer an IV. If staff involved feel that the patient would be better served through placement of an IV, then it is placed without question.

MORE ADVICE

Other pearls to share: It is important to inform patients preoperatively that they will not be going to sleep. Let them know that they will be awake but that they will feel sedated. Hand-holding for anxious patients can be helpful. Utilize vocal anesthesia by using encouraging phrases such as “Everything is going well” or “You’re doing great.”

Initially, many surgery centers and anesthesiologists may be skeptical of utilizing the MKO Melt due to lack of experience with this product. Certain steps may be taken to help ease the transition. At the beginning, it is best to continue placing an IV on all patients. The sublingual pill should be administered as previously described. Over time, gradually reduce the administration of medications through the IV.

When a certain level of confidence is achieved that intravenous medications are not required concomitantly with the MKO melt, the IV can be mostly eliminated.

We also use the Melt on other procedures besides cataract surgery, such as implantable phakic lenses, pterygium surgery and refractive lens exchanges.

Overall, we have found that the switch to the MKO Melt has been excellent. It is cost effective ($25 a pill) and provides for a predictable dosing. It reduces the number of anesthetic IVs needed and provides for a comfortable patient experience. Patients are less fearful of undergoing cataract surgery.

And there may be several challenges associated with an IV approach to anesthesia for both the surgery center and the patient. For instance, time and personnel must be allotted to both the set-up preoperatively and the take-down postoperatively. Additionally, the IV supplies have costs associated with them.

Utilization of this product has helped from a marketing perspective by increasing patient volume. Some patients select us for surgery since their friends told them that we could perform the procedure without an IV. Our staff is happier that they rarely need to start IVs.

Most importantly, as surgeons, we are comfortable with performing surgery on patients who are not anxious but are relaxed during the procedure. Just keep in mind that anytime there is a question of patient suitability, dispense with the Melt and start the IV. OM

About the Author

Dr. Shamik Bafna is a cataract and refractive surgeon at the Cleveland Eye Clinic. After finishing his medical degree at the University of Michigan, he completed his residency at the Cullen Eye Institute at the Baylor College of Medicine followed by a cornea and refractive fellowship at the New England Eye Center. His passion is the utilization of the latest technology to reduce an individual’s dependence on glasses.

Financial Disclosure: Dr. Bafna is a consultant to Imprimis.