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Chloral Hydrate and Its Effects on Multiple Physiological Parameters in Young Children: a Dose-Response Study Stephen Wilson, DMD, MA, Phd

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Chloral Hydrate and Its Effects on Multiple Physiological Parameters in Young Children: a Dose-Response Study Stephen Wilson, DMD, MA, Phd Chloral hydrate and its effects on multiple physiological parameters in young children: a dose-response study Stephen Wilson, DMD, MA, PhD Abstract This study evaluated the dose-responseeffect of chloral hydrate (CH)used alone on several physiological parametersin 26 healthy children 21 to 42 monthsold. Selection criteria for the children in this institutionally approvedstudy included: a) uncooperative behavior during an initial examination; b) a minimumof four sextants with caries involvement; c) healthy, ASAI; d) parental informed consent; e) a noncompromised airway (e.g., minimaltonsillar enlargement)and f) no knownallergies. A repeated measures, Latin-square design was used in evaluatingeither a placeboand three dosagesof CH(25, 50, 70 mg/kg)over four visits for each of eight patients or the samethree dosagesover three visits for each of the remainingpatients. The physiologicalparameters included: heart and respiratory rate, systolic and diastolic blood pressure, peripheral oxygen saturation, and expired carbon dioxide. For statistical purposes, physiological parameters were analyzed during specific phases which included: baseline, topical and local anesthesia administration, at initiation of cavity preparation; and at the end of the appointment. A repeated measures ANOVAand descriptive statistics wereused to analyzethe data.Theresults indicated that the diastolic blood pressureand expired carbon dioxide were affected significantly by CHdosage (P < 0.02 and 0.005, respectively). The findings should be temperedin light of patient behavior during the visits. Dental proceduresalso had an influence on cardiovascular parameters. The significance of these findings related to patient safety and behavior in these very youngchildren is discussed. (Pediatr Dent 14:171-77, 1992) Introduction Since the 1950s, most articles on sedation of children overly sensitive to mild behavioral (e.g., low-intensity for dental treatment have focused on the behavioral crying) or pharmacologic influence at moderate doses. changes mediated by pharmacologic agents. Occasion- For example, pulse oximetry measures the degree of ally, vital signs were mentioned, but rarely were they oxyhemoglobin saturation which may not be expected affected significantly. 1, 2 to significantly change unless profound alteration in The advent of modular and automated physiological respiratory function occurs (e.g., highly intense sob- monitors, along with other factors 3 has stimulated in- bing/crying and airway compromise). terest in the physiologic parameters of children receiv- The effect of chloral hydrate (CH) alone in a dose- ing4-14 sedative agents during dental treatment. response design on multiple physiological systems dur- Someof the first dental studies directly evaluating ing dental treatment has not been reported. The pur- changes (using specialized monitors) of physiological pose of this study was to determine the responsiveness systems of children as a function of sedative agents of appropriate physiologic systems to three doses of CH appeared as abstracts in 1984.15, 16 Subsequently, at and dentally related stimuli in a repeated measures least 16 articles reporting the quantitative physiological design. The following physiological parameters were data on a total of 386 patients have appeared in the investigated: heart rate (HR), respiratory rate (RR), literature.4-14, 17-21 In those studies, nine different tolic and diastolic blood pressure (SYS and DIA), ex- drugs, alone or in combinations, have been used. pired carbon dioxide (CO2), and oxygen saturation (02). Reported changes in physiological parameters have been associated, for the most part, with specific proce- Methodology dures (e.g., local anesthesia injection) that are painful Twenty-six healthy but uncooperative children par- anxiety-provoking to the children, rather than with the ticipated in this double blind, repeated measures dose- direct effects of the agents. 6 However,summary statis- response study using CH. All parents gave informed tics rarely are reported. Furthermore, there have been consent for their children to participate in this institu- few attempts to relate and report behavioral responses tionally approved study. Children participating were and/or pharmacologic influence on changes in physi- required to: be healthy; have a minimumof four of six ologic function, although information exists support- sextants of teeth that needed restoration or extractions; ing such associations. 10, 13 have uncompromised airways (i.e., no enlarged ton- A possible explanation for this hiatus in information sils); and have no knownallergies. is that the physiologic systems being monitored are not PEDIATRICDENTISTRY: MAY/JUNE, 1992- VOLUME14, NUMBER3 171 Each child was scheduled for either three or four were released with appropriate postoperative instruc- appointments. For the child who required three ap- tions. pointments, CH was administered in one of three doses Data for each physiologic parameter were collected (25, 50, 70 mg/kg) at each appointment. The rest of the either continuously or every 5 rain, depending on the children received CH and a placebo with the dose (25, monitor and its function. For statistical purposes, spe- 50, 70 mg/kg) of CH and placebo sequentially varying cial recording times were identified and included across appointments. (Note: The placebo visit was baseline, topical and local anesthesia administration, dropped after the ninth patient entered the study, be- initiation of tooth preparation with a high-speed cause we observed obvious distress in these very young handpiece, and the end of the operative procedures. All children due to the dental appointment imposed. This readings were obtained directly from the monitors. decision was made after it became clear to the author Descriptive statistics were used to characterize the that to continue would have been questionable, if not sample of children. A repeated measures factorial wrong morally and ethically.) ANOVAwas used to analyze each physiologic param- The sequence of drug-placebo visits was determined eter across dental procedures as a function of drug randomly in a Latin-Square design for each patient. dose. Ana priori level of statistical significance was set This investigator was the sole operator in this study, at 0.05. and the children were instructed to be NPOfrom mid- night before the morning of each appointment. All Results appointments began at 7 AMand usually were com- Thirteen females and 13 males whose mean age was pleted within 2 hr. The placebo was Tang , which also 30.8 _+ 4.5 months (range 21-42 months) with a mean was used to flavor the drugs. weight of 13.50 + 1.6 kg (range 10.5-17 kg) participated Usually, one week separated each visit for every in the study. Not every patient completed the planned child in this study. The following procedure occurred at sequence of visits, since some parents failed to return each appointment: the medical history was reviewed for scheduled appointments. The data set is based on for changes, then the child was weighed and taken with the following breakdown of patients completing visits: the parent to the dental operatory. Attempts were made four visits (8); three visits (11); two visits (4); and to obtain baseline information for SYS and DIA visit (3). (Dinamap, Model 1846-SX, Critikon, Inc., Tampa, FL), Those measures associated with respiratory function RR, HR and 02 (Nellcor pulse oximeter and printer, (RR and CO2) were missing most frequently because of Model N-100 and N-9000, respectively, Nellcor, Inc. patient crying and struggling patterns. Under those Hayward, CA), and CO2 concentration (Datex CO conditions, irregular RRare meaningless and expired Monitor, Model 223, Helsinki, Finland, manufactured air shunting through the oral cavity occurs. for Puritan-Bennett Corp., Wilmington, MA). During There was no significant difference noted among the restorative phase, the appropriately sized (pediat- physiologic systems as a function of visits, which sug- ric) inflatable blood pressure cuff always was placed on gested no visit-order effect. the right arm. The oxygen saturation electrode was Drug Dose Effect affixed to the first toe adjacent to the right large toe and Evaluation of the physiologic data during the speci- a small inverted thimble-like port was placed into the fied procedures (see above) with a repeated measures 2.right naris for detection of expired CO ANOVAindicated that CH dose produced significant The child then was administered either the placebo differences only on the physiological parameters of or CH and taken with the parent to a waiting area. The DIA and CO (Table 1, next page). All other parameters child remained with the parent in the waiting area for 2 did not show significant drug effects. A summary of 45 rain and was monitored periodically by dental per- descriptive statistics for each parameter is shown in sonnel. Then the child was separated from the parent Table 2 (page 174). and returned to the dental operatory, where all of the monitors were reattached and the child restrained in a Systolic Blood Pressure Papoose Board , Olympic Medical Group, Seattle, WA. No statistical difference among doses was seen for The operator administered topical and local anesthesia the SYS, but the SYSchanged significantly as a function (usually not exceeding I carpule of Xylocaine 2% with of dental procedure (F = 3.81, P < 0.005). The SYS epinephrine 1:100,000) and in most instances, placed increased from baseline during the period from admin-
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