TRIAZOLAM: A CLINICAL STUDY IN A GENERAL DENTAL OFFICE
Introduction
Over a two year period I have used triazolam about 150 times. Forty (40) times were for a double blind study of first time users. This study is yet to be analyzed. One hundred and five (105) uses are reported here. Initially, the patients were monitored by recording blood pressure and pulse. Later, pulse oximetry was added and finally an end tidal carbon dioxide monitor. The first time a patient used the drug we attempted to measure their amnesia. Initially, I feel many of the patients were undersedated. However, we had little guidance as to what dosage to use. Over time, I found sublingual administration could be used at the 30 minute mark where inadequate sedation was inevitable. I now have a dose-weight relationship that I am comfortable with and which rarely fails.
Methods
The patient population included 105 patients of a private dental practice. The mean age was 25.1 years (SD 18.9 years), with a range of 1.5 to 63 years. Average weight was 125.6 pounds (SD 83.7 pounds) with a range of 23 to 286 pounds. All patients were ASA 1 or 2 with no history of recent illness.
All adult patients were dental phobics who requested IV sedation or general anesthesia for their procedures. The children had previous attempts at treatment with conventional methods, including nitrous oxide, which were unsuccessful.
At a pre-appointment interview medical history was reviewed to determine that there are no contraindications to Triazolam. The procedures, possible risks, benefits and options were discussed with the patient or, in the case of children, with their parents. Our office protocol was explained, including the need for an adult to take the patient home, and the restrictions of their activities on the day of the appointment. It was stressed that we were not attempting to have the patient asleep, although they might experience amnesia for some or all of the appointment.
Patients assessed and recorded their apprehension on an analogue scale graded from 0 to 6. Numbers referred to the following states: 0 calm, relaxed; 1 a little nervous; 2 tense, upset; 3 afraid; 4 very afraid; 5 panicked; 6 terrified. Apprehension was reevaluated at 30 minutes and 60 minutes (the start of the procedure) and at the conclusion of the procedure.
Twenty-six (26) patients were shown 5 different symbols, one at a time, for 30 seconds. These symbols were shown at the start, at 30 minutes, at 60 minutes, half- way through the procedure, and at its completion. They received a sealed envelope with directions to open it the following day and circle the symbols they remembered from a sheet showing 16 symbols. They also were asked to record a narrative of their memory of the procedure.
Cardiovascular and respiratory parameters measured and recorded included blood pressure (systolic and diastolic), heart rate, percentage hemoglobin-oxygen saturation and end tidal carbon dioxide levels. With uncooperative children, only heart rate and oxygen saturation could be measured. Cardiovascular parameters were recorded every 15 minutes until the procedure was started. During the procedure, oxygen saturation and ETCO2 were continuously monitored by a Matrixª 3700 pulse oximeter and a Matrixª ETCO2 monitor.
After recording initial data, oral Triazolam was dispensed. Many authors have reported on the appropriate dosage for sleep enhancement. Suggested dosages range from .125 mg. to .5 mg. Initially, doses in this study were limited to .125 mg. and .25 mg. After several cases of inadequate sedation, I decided to administer one-half the initial dose after 30 minutes if there was no evidence of sedation. Supplemental dosages were necessary for 16 patients. The mean dosage was 0.0042 mg per pound (SD .0022 mg per pound) with a range of 0.00083 to 0.108 mg per pound.
At the close of the appointment the operator assessed relaxation on an analogue scale graded from 0 to 6. Numbers referred to the following: 0 asleep (to relaxed), 1 very relaxed, 2 easy to work with - slight relaxation, 3 normal patient, 4 slight apprehension (crying in the case of children), 5 difficult to work on and 6 uncontrollable.
RESULTS
Patient's apprehension report
Self-reported apprehension levels fell from an initial mean of 3.14 - SD 1.75 (afraid) to 1.97 - SD 1.49 (tense) at 30 minutes and to 1.41 SD 1.45 during the procedure and - 0.85 SD 1.28 (a little nervous) during and after the procedure. The largest drop in apprehension occurred in the first 30 minutes; the second largest drop in the second 30 minutes.
Amnesia
All 26 patients remembered the first symbol; 69% remembered the symbol shown at 30 minutes; 50% remembered the 60 minute symbol;40% remembered the symbol shown half-way through the appointment and 32% remembered the symbol shown at the conclusion of treatment. The narratives written by patients tend to agree with the amnesia reported with the symbols, 30% remembering the injection which occurred at 60 minutes. Only one patient recalled the whole appointment. Most remembered only small portions of it. A small control group of 3, all normal patients requiring no sedation for dentistry, remembered all 5 symbols.
Cardiovascular-respiratory parameters
Cardiovascular parameters had small changes. The systolic blood pressure fell 9% from a preoperative mean of 124 mmHg - SD l7.6 to 120 mmHg - SD 16.5 at 15 minutes and 117 mmHg - SD 116.7 from 30 minutes to completion. The diastolic blood pressure fell 7% from 79 mmHg - SD 11.7 mean preoperatively to 77.9-76.9 mmHg SD 14.5 - 9.5 from 15 minutes to completion. The heart rate fell from 91.3 beats per minute SD 21.1 to 89.7 SD 19.1 at 15 minutes, fell to 89.0 - SD 18.0 at 30 minutes, climbed to 91.4 SD 20.1 at 45 minutes and climbed to 94.3 - SD 20.7 after the injection of local anesthesia. Hemoglobin-oxygen saturation remained stable at 95.4 - 96.1 % for the whole procedure. End tidal carbon dioxide levels were monitored on the last 11 patients and recorded; it varied from 33.6 mmHg SD 2.7 to 35.0 - SD 2.76.
Dosages
Early dosages derived from reports in the literature for sleep enhancement proved inadequate for our purposes; 16 patients required additional drug. When dose in mg. and weight in pounds is compared with operator's assessment of level of sedation, a trend emerged indicating that the appropriate initial dosage could be determined by the following equation: Dose in mg. = .25 mg + .125 mg. for every 70 pound weight increment over 40 pounds. In the case of children under 40 pounds, the first treatment was attempted with 0.125 mg. In most cases this dose was ineffective. The mean dosage was 0.0042 mg per pound (SD .0022 mg per pound) with a range of 0.00083 to 0.108 mg per pound.
Discussion
It should be emphasized that this study was conducted coincidentally to the patient's treatment in a private practice. The technique described and the parameters evaluated evolved with drug familiarity. As questions arose, the study was expanded to investigate these areas. With the increased cost of malpractice insurance, it is difficult to justify the use of IV agents for the occasional sedation patient. Oral medication is an alternative. Determining dosage of drug early in the study was difficult. Many of the amnesia failures, higher levels of apprehension and lack of sedation which occurred were with patients who were undersedated because of a lack of knowledge as to what constituted an adequate dose. A much larger study is needed to confirm our findings.