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Triazolam and Dental Anxiety
personal stake in the outcome. T heir only purpose was to assess the accuracy and the “objectivity” of th e research methodologies, data collection and analysis, resu lts and conclusions of the clinical studies based on modern scientific sta n d a rd s and criteria. U nfortunately, the evidence from those studies w as found to be wanting. If th a t is “academ ic tyranny,” so be it! N orm an D. M ohl, D.D.S., Ph.D . B u ffalo, N.Y.
usually achieved by doubling the tim e required to achieve an SAL of 106. B ut w hen the Food and D rug A dm inistration sent dentists letters recom m ending th a t dental handpieces and related in stru m en ts be h eat sterilized betw een each patient use, no SAL was specified a t all! The FDA instead only m ade a “process recom m endation,” requiring th a t adequately cleaned handpieces be “h e a t sterilized.” S te v e n Ira F ein , D.D.S. K in gston , N.Y.
IS IT STERILIZED?
TRIAZOLAM AND DENTAL ANXIETY
The article on “The Emergence of Load-O riented Sterilization,” by Dr. Robert Kolstad (January 1994) will bring to the attention of m any dentists the concept of sterility assurance level. In discussing infection control issues w ith m any dentists, I discovered th a t m any naively assum ed th a t placing an item in a device labeled “sterilizer” and pressing a b u tton labeled “s ta r t” would produce an article which they could call sterile. A fter reading th is article, I am sure they will now understand th a t th e question of instru m en t sterilization is far more com plex, and th a t it is unacceptable to refer to som ething as “sterile,” w ithout specifying an SAL. Dr. Kolstad, however, does p resent th e im pression th a t because th e Food and Drug A dm inistration standards for sterilization devices utilize an SAL of 10'6, th a t this is the only sta n d a rd used by the FDA. In fact, FDA regulations include a t least two other standards. The FDA requires th a t item s of commerce be sterilized to an SAL of 1 0 12, 358
JADA, Vol. 125, April 1994
The article “U sing Triazolam to Reduce D ental Anxiety” by Dr s. C harles W. Berthold, Adam Schneider and Raymond A. Dionne (November 1993) is very helpful. The au th o rs’ review of Halcion’s excellent overall safety, its use in dentistry and th eir suggestions for its expanded use for relief of anxiety before and during tre a tm e n t should be helpful to th e public and th e profession. W hen needed, I prescribe non sedative dosage of anxiolytic, oral pre-m edications, or OPM, for my patients. I used mostly IV and occasionally IM sedation safely and successfully until th e cost of th a t insurance caused me to drop the paren tal coverage. D uring th a t tim e period I “titra te d ” each and every IV sedation case and learned a great deal from the titratio n process. P atien ts should not have to experience or experim ent w ith a placebo effect, or the incorrect tim ing of sedative effects. Safety being param ount, we
m u st not overdose our patients. Most frequently, I find patients have suffered from being underm edicated due to tim ing or inadequate dosage. The authors did not cover w hat I have found when tre a tin g the typical, reasonably healthy, am bulatory dental patient. W hen taking a health history, especially for a highanxiety case, particular inquiry m u st be m ade as to the p a tie n t’s anesthetic experi ences, usually hospital based; resistance or susceptibility to the effects of drugs and/or alcohol; frequency of drug and alcohol use; and consideration of the p a tie n t’s weight, age and size. A fter IV titra tio n with “sedative” doses of Demerol, Prom ethazine, barb itu rates and nitrous oxide analgesia, in doses assum ed by my colleagues to be supposedly lethal, I have h ad m any patients converse w ith us in perfect clarity to describe th eir hobbies, their pets or express th eir continuing anxieties. We need to know w hat is the p a tie n t’s “cerebral threshold” for alcohol and sim ilar m edications. For oral dosagetitratio n , we need to know w hat it takes to get the “first slight buzz.” Based upon my experiences w ith paren tal sedation and cu rren t experiences w ith oral m edications, both w ith nitrous oxide analgesia, I cannot accept dogma based on age or weight or both to determ ine supposedly “standardized” dosage or as in th e next to last paragraph, “no additional drug or higher doses,” in effect a “never more th a n .” U nfortunately, the authors do not w rite as or for practicing, clinical dentists;
[ETTERS th eir suggestions often will not be clinically relevant. T ransportation and dism issal in th e care of a responsible ad u lt is necessary for all sedation dosed, anxiolytic m edications. I dispense all sedative oral OPM. I do not prescribe sedative oral OPM. The dosage and the hour at which the m edication is to be tak e n are re-evaluated based on th e outcome and comfort of the patient. Sedative OPM is individually dispensed, usually for each following appointm ent, in pre-printed carefully labeled packaging. Microwaved hot w ater, in sufficient quantity, speeds the absorption tim e. Retrograde am nesia caused by the use of benzodiazepinetype drugs is a highly accept able side effect, even desired by m any patients. Halcion in higher doses or combinations, w here it is useful for sedationam nesia, is often needed to obtain th is effect. In addition to the m inim al dosage recommended by the authors, I advise all dentists to “know your p a tie n t.” M att K urzrock, D .D .S. T orrance, C alif. A u th o rs’ resp on se: We appreciate Dr. Kurzrock’s agreem ent w ith the conclusions of our article th a t triazolam is an effective and safe drug for anxiety reduction before o u tp atien t procedures. The in te n t of the article was to assu re the dental profession of the drug’s safety despite the adverse publicity in the lay press and to m ake recom m endations for using triazolam in dental outpatients. The adverse events reported for triazolam fall into three general categories: prescribing 360
JADA, Vol. 125, April 1994
the drug for prolonged periods as a hypnotic w ithout appro priate medical supervision; use of doses which have proven too high; and idiosyncratic reac tions, prim arily in the elderly. The dosing recom m endations m ade for the use of triazolam in our article attem p t to m inimize th e occurrence of such adverse events by suggesting th a t low doses be used initially and th a t th e dose only be increased if these lower doses prove ineffective. Like all drugs, however, the increased efficacy achieved w ith higher doses is likely to be accompanied by an increased incidence of side effects. A dm inistration of triazolam routinely to all patients a t doses g reater th a n 0.25 mg is likely to resu lt in benefit to those p atien ts not adequately sedated by lower doses b u t exposes all p atien ts to the adverse events associated w ith oversedation. Thus, we agree w ith Dr. K urzrock th a t some patients will be undersedated w ith a fixed dose of 0.25 mg but advise only increasing the dose when 0.25 mg has proven inadequate and w ith the knowledge th a t side effects will occur w ith g rea ter frequency. The recommended doses by weight in the table for pediatric p atients are based on generally accepted reference texts and the knowledge th a t overdosage is the m ost likely cause of m orbidity and m ortality following oral sedation in children. While individual p atien t variation, knowledge of th e p a tie n t’s anesthetic experiences and the ability of the clinician to m anage an overly sedated patien t are im portant considerations, the probability of adverse outcomes
will inevitably increase w ith g rea ter doses. The recom m endations for the use of triazolam in children a tte m p t to balance the needs of individual patients against the probability of adverse events if g rea ter th a n recommended doses of a sedative are combined w ith nitrous oxide and local anesthesia. We agree th a t anterograde am nesia, not retrograde am nesia, is a desirable effect for some patients. Based on our previous studies, however, it appears th a t a dose of 0.5 m g is needed to produce am nesia to clinical events b ut is associated w ith prolonged psychomotor recovery and delayed dism issal from th e dental office. Triazolam appears to be a n e a r optim al drug for oral sedation, w ith even greater efficacy associated w ith sublingual adm inistration. The m anagem ent of individual p atien ts requires not only the inform ation presented in the article b u t also appreciation for th e m any recom mendations m ade by Dr. Kurzrock. This m ay lead to the use of higher doses th an we recom m ended, but careful consider ation should be m ade of the th erapeutic benefit to the p atien ts against the need for more careful m onitoring and the possible risk associated with higher doses. R aym ond A. D ion n e, D.D .S., Ph.D . C h arles B erth old , D.D.S., M.S. N a tio n a l In stitu te o f D e n ta l R esea rch B eth esd a , Md. FAMILY VIOLENCE
On behalf of W ashington sta te ’s PANDA (Prevent Abuse and
usually achieved by doubling the tim e required to achieve an SAL of 106. B ut w hen the Food and D rug A dm inistration sent dentists letters recom m ending th a t dental handpieces and related in stru m en ts be h eat sterilized betw een each patient use, no SAL was specified a t all! The FDA instead only m ade a “process recom m endation,” requiring th a t adequately cleaned handpieces be “h e a t sterilized.” S te v e n Ira F ein , D.D.S. K in gston , N.Y.
IS IT STERILIZED?
TRIAZOLAM AND DENTAL ANXIETY
The article on “The Emergence of Load-O riented Sterilization,” by Dr. Robert Kolstad (January 1994) will bring to the attention of m any dentists the concept of sterility assurance level. In discussing infection control issues w ith m any dentists, I discovered th a t m any naively assum ed th a t placing an item in a device labeled “sterilizer” and pressing a b u tton labeled “s ta r t” would produce an article which they could call sterile. A fter reading th is article, I am sure they will now understand th a t th e question of instru m en t sterilization is far more com plex, and th a t it is unacceptable to refer to som ething as “sterile,” w ithout specifying an SAL. Dr. Kolstad, however, does p resent th e im pression th a t because th e Food and Drug A dm inistration standards for sterilization devices utilize an SAL of 10'6, th a t this is the only sta n d a rd used by the FDA. In fact, FDA regulations include a t least two other standards. The FDA requires th a t item s of commerce be sterilized to an SAL of 1 0 12, 358
JADA, Vol. 125, April 1994
The article “U sing Triazolam to Reduce D ental Anxiety” by Dr s. C harles W. Berthold, Adam Schneider and Raymond A. Dionne (November 1993) is very helpful. The au th o rs’ review of Halcion’s excellent overall safety, its use in dentistry and th eir suggestions for its expanded use for relief of anxiety before and during tre a tm e n t should be helpful to th e public and th e profession. W hen needed, I prescribe non sedative dosage of anxiolytic, oral pre-m edications, or OPM, for my patients. I used mostly IV and occasionally IM sedation safely and successfully until th e cost of th a t insurance caused me to drop the paren tal coverage. D uring th a t tim e period I “titra te d ” each and every IV sedation case and learned a great deal from the titratio n process. P atien ts should not have to experience or experim ent w ith a placebo effect, or the incorrect tim ing of sedative effects. Safety being param ount, we
m u st not overdose our patients. Most frequently, I find patients have suffered from being underm edicated due to tim ing or inadequate dosage. The authors did not cover w hat I have found when tre a tin g the typical, reasonably healthy, am bulatory dental patient. W hen taking a health history, especially for a highanxiety case, particular inquiry m u st be m ade as to the p a tie n t’s anesthetic experi ences, usually hospital based; resistance or susceptibility to the effects of drugs and/or alcohol; frequency of drug and alcohol use; and consideration of the p a tie n t’s weight, age and size. A fter IV titra tio n with “sedative” doses of Demerol, Prom ethazine, barb itu rates and nitrous oxide analgesia, in doses assum ed by my colleagues to be supposedly lethal, I have h ad m any patients converse w ith us in perfect clarity to describe th eir hobbies, their pets or express th eir continuing anxieties. We need to know w hat is the p a tie n t’s “cerebral threshold” for alcohol and sim ilar m edications. For oral dosagetitratio n , we need to know w hat it takes to get the “first slight buzz.” Based upon my experiences w ith paren tal sedation and cu rren t experiences w ith oral m edications, both w ith nitrous oxide analgesia, I cannot accept dogma based on age or weight or both to determ ine supposedly “standardized” dosage or as in th e next to last paragraph, “no additional drug or higher doses,” in effect a “never more th a n .” U nfortunately, the authors do not w rite as or for practicing, clinical dentists;
[ETTERS th eir suggestions often will not be clinically relevant. T ransportation and dism issal in th e care of a responsible ad u lt is necessary for all sedation dosed, anxiolytic m edications. I dispense all sedative oral OPM. I do not prescribe sedative oral OPM. The dosage and the hour at which the m edication is to be tak e n are re-evaluated based on th e outcome and comfort of the patient. Sedative OPM is individually dispensed, usually for each following appointm ent, in pre-printed carefully labeled packaging. Microwaved hot w ater, in sufficient quantity, speeds the absorption tim e. Retrograde am nesia caused by the use of benzodiazepinetype drugs is a highly accept able side effect, even desired by m any patients. Halcion in higher doses or combinations, w here it is useful for sedationam nesia, is often needed to obtain th is effect. In addition to the m inim al dosage recommended by the authors, I advise all dentists to “know your p a tie n t.” M att K urzrock, D .D .S. T orrance, C alif. A u th o rs’ resp on se: We appreciate Dr. Kurzrock’s agreem ent w ith the conclusions of our article th a t triazolam is an effective and safe drug for anxiety reduction before o u tp atien t procedures. The in te n t of the article was to assu re the dental profession of the drug’s safety despite the adverse publicity in the lay press and to m ake recom m endations for using triazolam in dental outpatients. The adverse events reported for triazolam fall into three general categories: prescribing 360
JADA, Vol. 125, April 1994
the drug for prolonged periods as a hypnotic w ithout appro priate medical supervision; use of doses which have proven too high; and idiosyncratic reac tions, prim arily in the elderly. The dosing recom m endations m ade for the use of triazolam in our article attem p t to m inimize th e occurrence of such adverse events by suggesting th a t low doses be used initially and th a t th e dose only be increased if these lower doses prove ineffective. Like all drugs, however, the increased efficacy achieved w ith higher doses is likely to be accompanied by an increased incidence of side effects. A dm inistration of triazolam routinely to all patients a t doses g reater th a n 0.25 mg is likely to resu lt in benefit to those p atien ts not adequately sedated by lower doses b u t exposes all p atien ts to the adverse events associated w ith oversedation. Thus, we agree w ith Dr. K urzrock th a t some patients will be undersedated w ith a fixed dose of 0.25 mg but advise only increasing the dose when 0.25 mg has proven inadequate and w ith the knowledge th a t side effects will occur w ith g rea ter frequency. The recommended doses by weight in the table for pediatric p atients are based on generally accepted reference texts and the knowledge th a t overdosage is the m ost likely cause of m orbidity and m ortality following oral sedation in children. While individual p atien t variation, knowledge of th e p a tie n t’s anesthetic experiences and the ability of the clinician to m anage an overly sedated patien t are im portant considerations, the probability of adverse outcomes
will inevitably increase w ith g rea ter doses. The recom m endations for the use of triazolam in children a tte m p t to balance the needs of individual patients against the probability of adverse events if g rea ter th a n recommended doses of a sedative are combined w ith nitrous oxide and local anesthesia. We agree th a t anterograde am nesia, not retrograde am nesia, is a desirable effect for some patients. Based on our previous studies, however, it appears th a t a dose of 0.5 m g is needed to produce am nesia to clinical events b ut is associated w ith prolonged psychomotor recovery and delayed dism issal from th e dental office. Triazolam appears to be a n e a r optim al drug for oral sedation, w ith even greater efficacy associated w ith sublingual adm inistration. The m anagem ent of individual p atien ts requires not only the inform ation presented in the article b u t also appreciation for th e m any recom mendations m ade by Dr. Kurzrock. This m ay lead to the use of higher doses th an we recom m ended, but careful consider ation should be m ade of the th erapeutic benefit to the p atien ts against the need for more careful m onitoring and the possible risk associated with higher doses. R aym ond A. D ion n e, D.D .S., Ph.D . C h arles B erth old , D.D.S., M.S. N a tio n a l In stitu te o f D e n ta l R esea rch B eth esd a , Md. FAMILY VIOLENCE
On behalf of W ashington sta te ’s PANDA (Prevent Abuse and