Should You Add Oral Sedation?

For many patients undergoing minor outpatient procedures like cataract surgery, the needlestick that's used to administer IV sedation is often the most painful part of the process. So why not eliminate this patient satisfaction-killer whenever you have an opportunity to do so?

Needle aversion is one of the primary reasons John Berdahl, MD, an ophthalmologist at Vance Thompson Vision in Sioux Falls, S.D., gives most of his patients sublingual sedation tablets consisting of midazolam (3 mg), ketamine HCI (25 mg) and ondansetron (2 mg). The "melts" are placed under the patient's tongue before surgery and take effect within minutes.

"Every facility has some form of oral sedation available for patients who refuse to have IVs started," says T. Hunter Newsom, MD, a cataract and refractive surgeon and the founder of the Newsom Eye & Laser Center in Sebring and Tampa, Fla.

Not having to place an IV is only one of the reasons to use oral sedation for cataract patients. "Anesthesia approaches vary so widely, and sublingual sedation brings a greater consistency to the process because we can avoid first pass metabolism. It also has rapid onset," says Dr. Berdahl.

The "sublingual troche" Dr. Berdahl uses generally is given in one-, one-and-a-half or two-tablet dosages. He estimates 40% of his cataract patients get one tablet, 30% get one and a half and the other 30% get two tablets before surgery. The dosage is driven primarily by age. "The older the patient, the less sedation they receive," says Dr. Berdahl.

The final and, according to Dr. Berdahl, potentially greatest big-picture benefit of oral sedation options is that they're opioid-free. "The ability to avoid fentanyl in cataract procedures is important," says Dr. Berdahl. "The literature shows patients who receive opioids only once can face problems of dependency."

With all the reported benefits, you'd think oral sedation would be a standard form of anesthesia for cataract surgeries. That's not the case. "There are some real barriers to adoption," says Dr. Berdahl.

For one, the current form of the midazolam-ketamine-ondansetron tablet isn't an FDA-approved product. "Even though it's compounded at a 503(b) outsourcing facility that undergoes the same scrutiny as traditional drug manufacturers, it's still a compounded product," says Dr. Berdahl. He believes that status is holding some facilities back from adding this conscious sedation option.

Cost in another barrier. Dr. Berdahl's facility compared the hard costs of sublingual sedation tablets and IV sedation, and found the tablets added $1 to $2 to case costs. "The price of the tablets is bundled into the facility fee for cataract surgery," says Dr. Berdahl.

"There's currently no separate billing mechanism."

For eye centers that often operate with razor-thin margins, this could present a major obstacle. But Dr. Berdahl believes it's short-sighted to conduct an apples-to-apples cost comparison between the sedation options. "When we included the soft costs of the time that it took anesthetists or members of our nursing staff to prep and start IVs, the troches were actually the less expensive option," says Dr. Berdahl.

We've grown accustomed to always having IV access, and a lot of anesthesia providers don't feel comfortable without it.
John Berdahl, MD

Even if you don't technically come out ahead cost-wise, time and convenience are two factors to consider. "You definitely save time with the tablets because you can sedate the patient without having to find a vein," says Dr. Newsom. "There's no doubt it's a more convenient and easier option."

While FDA status and cost are major obstacles, perhaps the greatest barrier is simply human nature. "I think one of the biggest factors [to a lack of widespread adoption] is a resistance to change," says Dr. Berdahl. "We've grown accustomed to always having IV access and a lot of anesthesia providers don't feel comfortable without it."

Facilities that aren't using sublingual sedation, or are using it only as a last resort, may want to rethink that approach. Dr. Berdahl believes the FDA will approve sedation tablets within the next 5 years. "We're also continuing to move away from opioids," he adds, "and that will lead to more non-IV alternatives for conscious sedation."

If you simply can't get comfortable with the idea of IV-free cataract surgery, Dr. Berdahl suggests establishing intravenous access and administering the troches until you gradually get used to relying on oral sedation alone. He believes you'll soon realize the IV isn't needed and eventually eliminate the extra step.

Dr. Berdahl points out anesthesia providers can still establish IV access quickly and easily in the rare situation it's needed. He estimates less than 5% of his cataract patients — those who are undergoing anticipated difficult procedures or those who are overly nervous — have an IV started as a back-up. Although the IV option is almost never used, it's always available. OSM