> -Chloral hydrate as a sedative (used in the dental office) was banned i
> WA state. Reasons not stated. (source Dentaltown, July 11, 2005). -
>
> \"CH in Washington State was DC'd about 10-12 years ago and was a
> exclusion in our malpractice policy...
>
> Versed is all we have used for many years at 0.25mg/kg--which is
> little light but safe. And baring cardiomyopathy, very little chance o
> sequela--death is a complication, not a sequela.\"
>
> -How widely used is chloral hydrate these days? Has it been replaced b
> Midazolam / Versed...other? -
>
> -Thanks, Sue-
>
> *Oral Midazolam Syrup as a Safe Sedative fo
> Pediatric Dentistry*
> Morton Rosenberg, D.M.D.
>
> ABSTRAC
>
> We report our experience with the use of the FDA approved ora
> midazolam syrup for uncooperative pediatric dental patients. Ou
> results confirm those of other investigators that oral midazolam is
> safe, effective oral sedative with a success rate at least equal if no
> greater to chloral hydrate. Palatability, need for supplementation wit
> nitrous oxide – oxygen, state of consciousness, incidence of cryin
> and oxygen saturation were also documented.
>
> INTRODUCTIO
>
> Chloral hydrate has long been the most popular oral sedative used i
> pediatric dentistry. The success rate measured by the ability to trea
> uncooperative pediatric patients for restorative dentistry has bee
> reported to be between 40 – 85% depending upon dosage, combinatio
> with other oral sedatives, and the co-administration of nitrou
> oxide-oxygen. ,,,
>
> Besides the many disadvantages inherent in any oral premedicatio
> (Table 1), in vivo and in vitro animal studies have raised the concer
> of the potential carcinogenicity of chloral hydrate due to it
> genotoxic effects causing chromosome changes. In addition, chlora
> hydrate is a reactive metabolite of trichlorethylene, a know
> carcinogen, and is structurally similar to other carcinogeni
> intermediates. Despite these disturbing preliminary animal studies
> chloral hydrate remains an essential and popular oral sedative acros
> the spectrum of pediatric medical and dental specialties.
>
> TABLE
>
> Disadvantages of Pediatric Oral Sedation
>
> - Patient and child non-compliance with instructions
> >   >   >

> when used for treatment of older, handicapped children.,, The risk
> of using recommended doses of chloral hydrate are minimal and cente
> upon tissue irritability and gastric upset, but can result i
> oversedation especially in children under the age of 2 or weighin
> less than 35 lbs. Vomiting following administration of chlora
> hydrate is often the only complication reported when usin
> recommended doses. The action of chloral hydrate is similar to th
> action of alcohol in depressing the central nervous system an
> inducing sleep as opposed to benzodiazepine sedation whic
> demonstrates more specific anti-anxiety effects. Despite thes
> caveats and with an awareness of the other problems associated wit
> all oral sedative agents, chloral hydrate remains an effective
> albeit non-specific central nervous system depressant, for th
> uncooperative pediatric dental patient as most recently evidenced b
> the excellent study of Ibricevic and Al-Jame in the Dental News.2
>
> The introduction of the benzodiazepines into clinical practice was
> revolutionary in providing health care providers with selective
> anti-anxiety agents combined with a great margin of safety as
> compared with barbiturates and other older central nervous system
> depressants. Benzodiazepines appear to exert their pharmacologic
> effects by their interaction with the receptor for the inhibitory
> neurotransmitter, gamma-amino butyric acid (GABA) in the central
> nervous system. Benzodiazepines all possess sedative, anxiolytic,
> amnesic and hypnotic properties in varying degrees . However, oral
> diazepam (Valiumâ ), the most popular oral benzodiazepine
> premedication, although providing excellent anxiety relief in adults
> has had mixed reviews for the pediatric patient. 11
>
> Midazolam hydrochloride (Versedâ ), a short-acting, water-soluble
> benzodiazepine, is rapidly absorbed intramuscularly, intravenously,
> nasally, rectally and via the gastrointestinal tract. Although not
> approved by the Federal Drug Administration (FDA), anesthesiologists
> have long popularized oral administration of midazolam as a safe and
> effective premedication prior to general anesthesia. Besides the
> medical legal ramifications of using a drug in a manner other than
> what appears on FDA-approved and mandated labeling, the parental form
> of midazolam was terribly bitter tasting and had to be admixed by the
> practitioner with a sweet vehicle to make it palatable. However, the
> recent FDA approval and availability of midazolam syrup as a
> cherry-flavored syrup with its potential for greater efficacy and
> safety than older drugs will further increase its popularity for
> pediatric sedation. We report our experience with oral midazolam in
> the treatment of the uncooperative, pediatric dental patient.
>
> *Methods*
>
> Seventy-five children ranging in age from 36 months to 7 years of age
> (mean age 5.1 years) were referred to the Tufts University School of
> Dental Medicine Pediatric Sedation Clinic due to inability to perform
> restorative dental procedures due to behavior issues. All patients
> were American Society of Anesthesiology Physical Status I and were
> fasting 6 hours prior to appointment. Patients were administered oral
> Versed â (midazolam HCL) syrup (.05 mg/kg) via oral dispenser by
> their parents. After administration, the children remained in the
> waiting room with observation by dental staff. The patients were
> brought into the operatory when the parents indicated that they felt
> their children would accept the dental environment. Parameters
> measured included palatability, success rate of treatment, incidence
> of crying, necessary supplementation of oral technique with nitrous
> oxide - oxygen, incidence of gastric upset, and oxygen saturation
> (Sp02) via a BCI International Monitor (Waukesha, Wisconsin, USA) and
> finger sensor.
>
> *Results*
>
> Palatability
>
> Palatability was assessed by facial grimaces and struggling in
> response to taste. Seventy-seven per cent ( 58/75) of the children
> accepted the medication without severe grimacing or struggling. In
> thirteen percent (10/75) of the children, struggling and severe
> facial grimacing were encountered. Nine percent (7/75) either totally
> refused or would only accept small aliquots of the syrup despite
> parental and staff encouragement.
>
> Supplementation with Nitrous Oxide – Oxygen Sedation
>
> Twelve per cent (8/68) children were administered nitrous oxide
> –oxygen to increase the depth of sedation in order to accept local
> anesthesia and be amenable for dental treatment. Of this group, two
> children were still unable to be treated.
>
> Ability to Achieve Local Anesthesia/Perform Procedure (Success Rate)
>
> From the original cohort of 75 patients, the rate of successful
> treatment was 84 per cent (63/75). Failures included: 7 children who
> refused medication, 2 children who continued to be uncooperative
> after the addition of nitrous oxide – oxygen, 3 children who
> remained uncooperative to the point of even refusing placement of the
> nitrous oxide – oxygen nasal hood.
>
> *State of Consciousness*
>
> During dental treatment, 7.4 % of the children were classified as to
> being alert by observers (This group included all of the patients
> unable to be treated.), 88.2% were drowsy/sedated and 4.4 % were
> sleeping. All of patients classified as sleeping also received
> nitrous oxide – oxygen supplementation.
>
> alert
>
> drowsy/sedated
>
> sleeping
>
> 7.4% (5/68)
>
> 88.2%(60/68)
>
> 4.4%(3/68)
>
> Crying
>
> During injection of local anesthesia, the following table describes
> the data on the incidence of crying.
>
> no crying
>
> minimal crying
>
> mild crying
>
> crying
>
> 31.7% (20/63)
>
> 28.6% (18/63)
>
> 23.8% (15/63)
>
> 15.8% (10/63)
>
> Oxygen Saturation
>
> Oxygen saturation (Sp02) remained between 96 – 98% for all patient
> sedated with oral midazolam with and without nitrous oxide – oxyge
> supplementation.
>
> Gastric Upset
>
> There were no cases of gastric upset (nausea or vomiting) reported.
>
> *Discussion*
>
> With its rapid absorption from the gastrointestinal tract, ora
> midazolam became an extremely popular oral premedication fo
> pediatric patients in the hospital setting although it was no
> available as an FDA approved oral preparation. The drug was use
> mainly to facilitate parental-child separation prior to the inductio
> of anesthesia as well as provide sedation and amnesia. Although highe
> doses have been advocated, there appears to be an optimal balanc
> between anxiolytic activity and side effect liability in doses o
> 0.25 mg to 0.50 mg/kg. to a maximum of 20 mg with the dose bein
> individualized based upon patient age, (older children need less o
> the drug), degree of anxiety, and the level of sedation desired.
> Higher doses of midazolam (0.75 – 1.0 mg/kg) result in greater sid
> effects especially regarding loss of balance and head control whic
> could result in airway obstruction when compared with the .5mg/ k
> recommended dose.15 “Fixed” oral doses of sedative drugs are
> dangerous practice in pediatrics and should be avoided and wheneve
> possible drugs should be administered as calculated by body weight o
> surface area.. Oral midazolam has been shown to reduce anxiet
> significantly when compared with oral diazepam and a placebo.
>
> The palatability of oral midazolam syrup as demonstrated in ou
> results confirm the fact that this drug is much better tolerated an
> accepted than chloral hydrate where facial grimacing and strugglin
> have been reported in up to 50% of children receiving the drug. Ou
> success rate and measurements of efficacy, crying, and state o
> consciousness compared favorably with results in studies evaluatin
> chloral hydrate for sedation during pediatric dental procedure
> 2,4,5,7,10, and confirm other studies advocating oral midazolam as a
> effective and safe sedative for children.4,,,, It is important to not
> that although there was a small percentage of patients who were aslee
> during treatment (4.4%), all of them occurred with th
> co-administration of nitrous oxide –sedation. The potentiation o
> oral midazolam by nitrous oxide has been documented and can result i
> clinically significant airway obstruction especially in the presenc
> of enlarged tonsils. Despite the fact that oxygen saturation
> remained in acceptable ranges for every case during this study, w
> advocate the use of pulse oximetry as a simple, non-invasive monito
> whenever a central nervous system depressant is administered to
> child.
>
> Versed â Syrup is supplied in a bottle with a child-resistant bottl
> cap and press-in bottle adapter (PIBA). A graduated, oral dispense
> easily inserts in the PIBA. Each mL of syrup contains 2 mg o
> midazolam.
>
> *Conclusion*
>
> Oral midazolam is a safe, effective sedative choice for uncooperativ
> children for dental procedures. This margin of safety can only b
> maintained with the following caveats in place:
> >   >   >

> provide access to care for all children especially those wit
> behavioral issues. The introduction of oral midazolam provides
> dentistry with safe, effective method of sedating the uncooperative
> pediatric patient and avoiding the alternative of general anesthesia.
> This enthusiasm must be tempered, however, by a careful analysis of
> the risk/benefit ratio inherent in any pharmacologic intervention,
> and the realization that success and safety depends upon the training
> and adherence to basic safety standards by the dentist.
>
> 1-houpt m. project usap the use of sedative agents in pediatric
> dentistry:1991 update. pediatric dentistry 1993 january-february
> 15:36-40.
>
> 2 ibricevic h, al-jame q. chloral hydrate as a sedative in
> dental treatment of young children as alternative to general
> anesthesia. dental news 1998 5:27-30.
>
> 3 scott tr, kenneth rw, wrobleski j, synthia l, hardin ml,
> pinosky a. a randomized double-blind trial of chloral
> hydrate/hydroxyzine versus midazolam/acetaminophen in the sedation of
> pediatric dental outpatients. j dent child 1996 march – april
> 63:95-100.
>
> 4 dunkan wk, de ball s, perkins tm. chloral hydrate sedation:a
> simple technique. compendium 1994 july 15:886-888.
>
> 5 houpt m, shesskin rb, koenigsberg rs, desjardins pj, sheyz.
> assessing chloral hydrate dosage for young children. j dent child
> 1985, september – october 52:364-369.
>
> 6 salmon ag, kizer kw, zeise l, jackson rj, smith mt. potential
> carcinogenicity of chloral hydrate – a review. j toxicol clin
> toxicol 1995 33:115-121.
>
> 7 moore pa. therapeutic assessment of chloral hydrate
> premedication of pediatric dentistry. anesthesia progress 1984
> 31:191-196.
>
> 8 smith rc. chloral hydrate sedation for handicapped children:a
> double blind study. anesthesia progress 1977 24:159-161.
>
> 9 barr es. oral premedication for the problem child: placebo
> and chloral hydrate. j ped 1977 1:272-280.
>
> 10 moore pa, mickey ea, hargreaves ja, needleman hl. sedation
> in pediatric dentistry. a practical assessment procedure. j am dent
> assoc 1984 109:564-569.
>
> 11 needleman hl, griffith dg. conscious sedation of pediatric
> dental patients using chloral hydrate, hydroxyzine, and nitrous
> oxide-a retrospective study of 382 sedations. pediatric dentistry
> 1995 7:424-31.
>
> 12badalaty mm, houpt mi, koenigsberg sr. a comparison of
> chloral hydrate and diazepam sedation in young children. ped dent
> 1990 12:33-37.
>
> 13malinovsky j, populaire c, cozian a et al. premedication with
> midazolam in children. effect of intranasal, rectal and oral routes on
> plasma midazolam concentrations. anaesthesia 1995 50:351-354.
>
> 14feld l, negus j, white p. oral midazolam. preanesthetic
> medication in pediatric outpatients. anesthesiology 1990
> 73:831-834.
>
> 15mcmillan co, spahr-schopfer ia, skich n, et al.premedication
> of children with oral midazolam. canadian journal of anaesthesia 1990
> 39:545-550.
>
> 16package insert, versedâ (midazolam hcl) syrup, roche
> laboratories, nutley, nj, usa, 1998.
>
> 17parnis sj. foate ja, van der walt jh, et al. oral midazolam
> is an effective premedication for children having day-stay
> anaesthesia. anaesthesia and intensive care 1992 20:9-14.
>
> 18saarnivarra l, lindgren l, u-m klemola. comparison of chloral
> hydrate and midazolam by mouth as premedicants in children undergoing
> otolaryngological surgery. british journal of anaesthesia 1988
> 61:390-396.
>
> 19gallardo f, cornejoo g, borie r. oral midazolam as
> premedication for the apprehensive child before dental treatment.
> journal of clinical pediatric dentistry 1994 18:123-127.
>
> 20krafft tc, kramer n, kunzelmann k-h, et al. experience with
> midazolam as sedative in the treatment of the uncooperative child.
> journal of dentistry for children 1993 60:295-299, 1993.
>
> 21smith bm, cutilli bj, saudners w. oral midazolam:pediatric
> conscious sedation. compendium continuing educ dental 1998
> 19:586-592.
>
> 22dionne r. oral midazolam syrup:a safer alternative for
> pediatric sedation. compendium continuing educ dental 1999
> 20:221-230.
>
> 23litman rs, berkowitz rj, ward ds. levels of consciousness and
> ventilatory parameters in young children during sedation with oral
> midazolam and nitrous oxide. archives of pediatric and adolescent
> medicine 1996 150:671-675.
>
> 24litman rs, kottra ja, berkowitz rj, ward ds. upper airway
> obstruction during midazolam/nitrous oxide sedation in sedation in
> children with enlarged tonsils. pediatric dentistry 1998 50:
> 318-320.