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Behavioral Assessments of Two Drug Combinations for Oral

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Behavioral Assessments of Two Drug Combinations for Oral SCIENTIFIC ARTICLE Behavioral assessmentsof two drug combinationsfor oral sedation Deirdre R. Sams, DDS, MS EdwinW. Cook, PhD Janice G. Jackson, DMDBob L. Roebuck,DMD Abstract This study comparesthe efficacy of two drug regimensused for oral sedation in pediatric dental patients: chloral hydrate (50 mg/kg)/promethazine (1 mg/kg) and meperidine (1 mg/kg)/promethazine (1 mg/kg). Twenty-four pediatric dental patients, ASAClass I, were evaluated in this double-blind, randomizedstudy. The patients ranged in age from 18 to 48 months. Each dental procedure under sedation was videotaped and rated independently by two raters. Intraoperative ratings of sleep, movement,crying, an overall behavior score for each treatment interval, and an overall behavior score for each sedation were also evaluated. No treatment was aborted for either regimen. In all cases, chloral hydrate/promethazine sedations had significantly better results)or sleep (P = 0.0001), movement(P = 0.0168), crying (P = 0.0041), and overall behavior score = O.0186)for the sedations comparedto meperidine/promethazinesedations. Although chloral hydrate/promethazinesedations producedsignificantly better results, clinically, both drug regimenswere equally effective. (Pediatr Dent 15: 186-90, 1993) Introduction Oral sedation regimens including single and multiple ized study was to compare the effectiveness of chloral agents have been used to treat the very young, mentally hydrate / promethazine and meperidine / promethazine in handicapped, and physically handicapped pediatric den- controlling behavior during treatment and determine dif- tal patient. Premedication agents that have been used in ferences, if any, in behavioral ratings. combination include chloral hydrate, promethazine, hy- droxyzine, meperidine, diazepam, fentanyl, and Methods midazolam.1 A survey conducted by Duncan et al. 2 on 1. Subjects premedication practices of the American Board of Ped- Twenty-four patients between the ages of 18 and 48 iatric Dentistry Diplomatesindicates that chloral hydrate months participated in this study. Thirteen patients were is frequently used in combination with hydroxyzine or assigned randomly to receive chloral hydrate/ promethazine. Meperidine also is used frequently either promethazine sedation whereas 11 patients were assigned alone or in combination with promethazine. Manyseda- meperidine/promethazine. All patients were ASAClass tion studies have reported behavioral assessments for ped- I status with no prior sedation experience who needed iatric dental patients receiving chloral hydrate/hydrox- two or more restorations. Based on a preoperative assess- yzine with and without meperidine.3,4’ 5 ment using the Frankl Scale, ~3 all children demonstrated Results of a comparative study administering chloral "definitely negative" behavior during pretreatment evalu- hydrate with and without promethazine to pediatric den- ations. This study met all the requirements and guidelines tal patients indicate that improved behavioral responses outlined by the Institutional Review Board and was con- were evident with chloral hydrate/promethazine; how- ducted under an approved protocol. Informed consent ever, the differences are not statisticatly significant.6 Houpt was obtained from at least one parent for each patient. et al. 7 published similar results in their study involving 50 mg/kg or 75 mg/kg chloral hydrate alone compared with 2. Procedure 50 mg/kg chloral hydrate and 25 mg promethazine. Me- Preoperativetreatment peridine/promethazine drug combinations compared Patients received either 50 mg/ kg chloral hydrate (Barre with meperidine administered alone have been reported National,® Inc., Baltimore, MD)and I mg/kg Phenergan to improve sedation and analgesia, and decrease nausea (Wyeth Lab Inc., Philadelphia, PA) or 1 mg/kg each and vomiting during labor and delivery. 8,9 Lampshire~° Demerol® (Winthrop Pharmaceuticals, New York NY) first suggested the meperidine/promethazine drug com- and Phenergan® (WyethLab, Inc., Philadelphia, PA). Nasal bination for pediatric dental patients in a balanced hood placement to administer oxygen and/or nitrous ox- premedication technique for oral or intramuscular ad- ide was accomplished on all patients. Twenty-one pa- ministration. Early clinical studies with successful results tients received nitrous oxide/oxygen. Three patients did involving comedication with meperidine in pediatric den- not receive nitrous oxide / oxygensedation because of their tal patients have been reported by Albumand Droter21, ~2 behavior. One patient, 29 months and 13.6 kg, who was The purpose of this controlled, double-blind random- sedated with chloral hydrate (650 mg)/promethazine (13 186 Pediatric Dentistry: May/June,1993 - Volume15, Number3 rag) displayed excellent behavior; therefore, the operator Table1. Sedationscore sheet chose not to use nitrous oxide. The other two patients, 24 (Adaptedfrom Houpt et al. PedDent 7(1):42, 1985) months, 12.2 kg and 45 months, 13.6 kg were sedated with Rating Scale Score meperidine (12 mg, 13.6 mg)/promethazine (1), mg, mg), respectively. These patients exhibited extreme head/ A. Rating scale for sleep body movementsthat made stabilization of the nasal hood Fully awake,alert 1 for administering oxygen and/or nitrous oxide difficult. All patients were restrained in a PapooseBoard ® (Olympic Drowsy,disoriented 2 Papoose Board, OlympicMedical Corp., Seattle, WA)with- Asleep 3 out a head restraint. A shoulder roll was used during each B. Rating scale for movement treatment session. One of two operators conducted a routine preoperative treatment evaluation that included Violent movementinterrupting treatment 1 vital sign recordings of blood pressure, heart rate oxygen Continuous movement 2 saturation, respiratory rate, and temperature. The princi- makingtreatment difficult pal investigator or an attending faculty memberadminis- Controllable movementthat 3 tered the medication. Because of the double-blind nature does not interfere with treatment of the study, no operator was allowed to administer any No movement 4 medications. All patients were NPO_<8 hours prior to drug administration. After administering the drug regimen, each C. Rating scale for crying patient was taken to the sedation quiet roomwith the parent Hysterical crying that demandsattention 1 and monitoredperiodically by staff members. Continuous, persistent crying 2 Intraoperativetreatment that makestreatment difficult Sixty min post drug administration (PDA), each patient Intermittent, mild crying that does 3 was brought into the treatment operatory and placed into not interfere with treatment the Papoose Board. Monitors for physiologic vital sign No crying 4 recording were placed. Afterwards, the nasal hood was D. Rating scale for overall behavior placed to administer oxygen and/or nitrous oxide and treatment was rendered. Aborted--no treatment rendered 1 Poor--treatment interrupted, 2 Postoperativetreatment only partial treatment completed The operator assessed the criteria for discharge as out- Fair--treatment interrupted, 3 lined in the guidelines by the AmericanAcademy of Pedi- but eventually all completed 14 atric Dentistry and discussed written postoperative in- Good--difficult, but 4 structions with the parent. Approximately 6-8 hr after all treatment performed discharge, a telephone interview was conducted with the Very good--somelimited crying or 5 parent to assess any postoperative complications. movement,e.g., during anesthesia 3. Evaluation or mouthprop insertion Each patient was evaluated independently by two rat- Excellent--no crying or movement 6 ers from videotaped treatment sessions. A numerical score was assigned for each treatment interval for sleep, movement,crying, an overall behavior score for that inter- val, and an overall behavior score for each sedation (Table 1), 7 Intraoperative assessments were madeat 10 treatment 4. Data analysis intervals: The data for this study were analyzed to determine if ¯ 60 min post drug administration (PDA) there were any differences between the two drug regi- ¯ during placement of the patient into the Papoose mens for sleep, movement, crying, and overall behavior Board score measuredat 10 sequential treatment intervals. The ¯ during placement of the blood pressure (BP) cuff overall evaluation of the sedations was also analyzed. For (Accutorr, TM Datascope Corp., Paramus, NJ) a global comparison of the four variables sleep, move- ¯ during placement of the pulse oximeter probe ment, crying, and overall sedation evaluation, Hoteling’s (Accustat, Datascope Corp., Paramus, NJ) T~ test was used. To analyze the mean for sleep, move- ¯ during placement of the nasal hood ment, crying, and the overall rating of the 10 treatment ¯ during placement of the mouth prop insertion phases for the raters, a two-samplet-test was used. Find- ¯ during injection (INJ) ings were considered significant if a P-value < 0.05 was ¯ 15, 30, and 45 min postinjection. attained. PediatricDentistry: May/June, 1993 - Volume15, Number3 187 Table2. Sedationtreatment procedures variability in the P-values is possibly related to the small Amalgams Extractions Stainless Pulpotomies Pulpectomies sample size. Drug Regimen Steel Crowns 2. Evaluationof treatment Chloral hydrate/ 9 8 42 12 2 intervals(Table 3) promethazine Sleep Meperidine/ 15 4 29 6 6 It wasevident fromthe vid- promethazine eotaped sessions that patients sedated with chloral hydrate / promethazine were more Results drowsy compared to meperidine / promethazine sedations. There was no statistically
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