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, hydroxyzine, 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 interval, 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 significant difference for For all of the treatment intervals, there were statistically the drug regimens based on the ages and weights of the significant differences between the two regimens except patients. The mean age for patients sedated with chlo- at 45 rain postinjection. ral hydrate/promethazine was 31.0 (+ 8.6 SD) months and the mean weight was 13.3 (+ 2.74 SD) kg. For the Movement meperidine/promethazine sedations, the mean age was The meanratings for both regimens indicated that the 35.8 (+ 10.6 SD) months and and mean weight was 13.4 patients’ movementswere controllable and did not inter- (+3.32 SD) kg. The mean treatment times for patients fere with treatment. Statistically significant results for sedated with chloral hydrate/promethazine and me- chloral hydrate/promethazine compared to meperidine/ peridine/promethazine were 50.8 (+13.3 SD) rain, 50.9 promethazine indicated chloral hydrate/promethazine (+ 17.6 SD) min, respectively. No statistically signifi- was better for treatment intervals: 60 min postdrug ad- cant difference was noted between the regimens for the ministration, at placement of nasal hood, and 15 and 30 time of treatment. Patients sedated with chloral hy- min postinjection. Howeverclinically, both regimens were drate/promethazine had 73 procedures completed com- successful in controlling movement. pared to 60 completed procedures for meperidine/ promethazine sedations (Table 2). Crying Meanratings for crying indicated both sedation groups 1. Evaluationof rater consistency experienced intermittent to no crying at all. The overall Tworaters were standardized in training sessions to evaluation for crying was rated fair. Statistically, chloral establish inter-rater reliability prior to the study. The hydrate/promethazine sedation resulted in significantly calibrated rating sessions were done by reviewing video- less crying 60 rain after drug administration, during place- taped oral sedations that involved patients whowere simi- ment of the oxygensaturation monitor, nasal hood, and 15 lar in age and treatment needs to the proposed study min postinjection. Patients sedated with meperidine/ patients. The raters reviewed each treatment interval and promethazine cried more during the treatment sessions. the last 3 rain of each 15-min time segmentafter the injection procedure. Overall treatment behavior The two raters were compared for consistency in as- For each treatment interval, an overall behavior score sessing the variables for the 10 treatment intervals. The was assigned. Results indicated chloral hydrate/ paired t-test indicated differences between the raters for promethazine sedations were considered very good com- someof the variables of interest. These minor differences pared to good for meperidine/promethazine sedations. had little effect on the results based on Spearman’srank Overall, chloral hydrate/promethazine produced better correlation. A significant correlation existed betweenthe sedative results based on the meanratings that were statis- raters for sleep (r = 0.78, P = 0.0001), movement(r = 0.63, tically significant for treatment intervals: 60 min after drug = 0.0009), crying (r = 0.76, P = 0.0001), and overall evalua- administration, placement of the oxygen saturation moni- tion (r = 0.75, P = 0.0001). However,due to these differ- tor, 15 and 30 min postinjection procedures. ences, each rater’s dataset was analyzed separately and then combined. A multivariate statistical analysis exam- 3. Evaluationof overall sedation(Figure) ined all four variables (sleep, movement,crying, overall There was a statistically significant difference between evaluation) collectively for both drug regimens. Based on the regimensfor each rater (rater I P = 0.0051, rater 2 P the Hotelling’s T2 test, there was a statistically significant 0.0030) and for the combinedrater score (P = 0.0001). In difference betweenregimens for rater I (P = 0.0051), rater cases, chloral hydrate / promethazinesedations were rated 2 (P = 0.0030), and the combinedrater score (P = 0.0001). more effective than meperidine/promethazine sedations Although variability existed between the raters, the re- for sleep (P = 0.0001), movement(P = 0.0168), crying suits using the multivariate method were consistent. The 0.0041), and overall evaluation (P = 0.0186).

188 Pediatric Dentistry: May/June, 1993 - Volume15, Number3 Table3. Meanevaluations of treatmentintervals

Drug 60 min Papoose 02 BP Nasal Mouth 15 min 30 min 45 min Regimen PDA Board Sat Hood Prop INJ Post-IN] Post-INJ Post-INJ Chloral hydrate / promethazine Sleep 2.7" 2.4" 2.4" 2.3" 2.2" 2.2" 2.1" 2.7" 2.5" 2.4 (SD) (0.6) (O.7) (O.8) (O.8) (O.7) (0.5) (0.5) (O.5) (O.6) (0.6) Movement 3.9" 3.3 3.3 3.3 3.2" 3.0 2.9 3.6" 3.7" 3.4 (SD) (0.4) (0.9) (0.9) (1.0) (0.8) (0.7) (0.6) (0.8) (0.7) (0.4) Crying 3.8" 3.4 3.4" 3.2 3.1" 2.9 2.6 3.3" 3.3 3.2 (SD) (O.5) (O.9) (0.9) (1.0) (0.9) (0.8) (0.8) (0.8) (O.9) (O.8) Overall 5.6" 5.0 5.1" 4.9 4.6 4.5 4.5 5.2" 5.3" 5.1 (SD) (0.6) (1.1) (1.1) (1.2) (1.4) (1.0) (0.9) (1.1) (1.0) (1.0) Meperidine / promethazine Sleep 1.5 1.4 1.4 1.5 1.5 1.5 1.5 1.8 2.0 2.2 (SD) (0.7) (0.5) (0.5) (0.6) (0.6) (0.7) (0.7) (0.8) (0.9) (1.0) Movement 3.2 3.1 3.2 3.0 2.7 2.8 2.7 3.0 3.2 3.3 (SD) (0.7) (0.8) (0.9) (0.8) (0.9) (1.0) (1.0) (1.0) (0.8) (0.8) Crying 3.1 2.9 2.9 2.9 2.4 2.5 2.4 2.8 2.8 3.0 (SD) (1.0) (1.0) (1.0) (0.9) (1.0) (1.1) (1.1) (1.0) (1.1) (0.9) Overall 4.8 4.6 4.5 4.4 4.0 4.2 4.1 4.4 4.5 4.7 (SD) (1.1) (1.1) (1.1) (1.1) (1.3) (1.4) (1.3) (1.3) (1.4) (1.2) ¯ Significantdifference at 0.05level between the two regimens for this variable.

aborted. Clinically, no significant difference occurred between the regimens for move- ¯ ~ Hydrate / Promcthazine ment, crying, and overall evaluation. With clinical trials, statistical significancedoes not necessarily indicate which treatment is best clinically. Both regimens proved to be effective based upon the completion of all treatment procedures. Seventy-three procedures were completed on patients sedated with 3 chloral hydrate/promethazine compared to 60 procedures for meperidine / promethazine sedations. The majority of the dental treatment for chloral hydrate/promethazine sedations include pulpotomies and stainless steel crowns. For meperidine / promethazine sedations, most of the restorations were amal- gamsand stainless steel crowns. Houptet al. 7 report no statistically signifi- SLEEP MOVEM]~ CRYING OVERALL cant difference between chloral hydrate (50 rag/kg)/promethazine (25 rag) and 75 rag/ kg of chloral hydrate alone for the samevari- Figure.Overall sedation ratings. ables; however, 90%of the combined drug regimen sedations were judged to be better Discussion clinically. Poormanet al. 4 also report similar results with Theresults of this study indicated that chloral hydrate / their study comparing chloral hydrate / hydroxyzine with promethazine sedations were more effective than meperi- and without meperidine. The authors found no statisti- dine / promethazine sedations regarding sleep, movement, cally significant differences betweenthe regimensfor sleep, crying, and overall evaluation of the sedations. Of the 24 movement,crying, and overall evaluation; however, both subjects evaluated in this study, not one had treatment regimens produced effective sedations.

PediatricDentistry: May/June, 1993 -Volume 15, Number3 189 The use of nitrous oxide was a variable in this study. This project was submitted in partial fulfillment of the requirements All study participants were to receive nitrous oxide; how- for the degree of Master of Science in the Department of Community and Public Health Dentistry in the Graduate School at The University ever, three patients did not have this drug administered. of Alabama at Birmingham. Twopatients exhibited poor behavior, making the stabilization of the nasal maskdifficult and were sedated with Drs. Araya Phonghanyudh and Claudia Tomaselli served as operators in this study. These colleagues were instrumental to the success meperidine/promethazine. The third patient exhibited of this project. Special thanks to Dr. Joe P. Thomasfor his support, Dr. an excellent sedative state, thus the operator did not ad- John B. Thornton for having served as research advisor, and Dr. minister nitrous oxide. Inspecting the ratings suggested Steven M. Adair for his assistance in the preparation of this manu- that adding this agent would not have improved the be- script. havior of these children or changed the outcome of the Dr. Samsis assistant professor in pediatric dentistry, Medical College ratings. of Georgia, Augusta. Dr. Cook is associate profesoor in psychology at The behavioral effects of sedation procedures are University of Alabama at Birmingham. Dr. Jackson is associate very difficult to evaluate objectively. Current sedation clinical professor and Dr. Roebuckis clinical professor, University of Alabama at Birmingham, School of Dentistry, Children’s Hospital of studies,4, is as well as our investigation, use the rating Alabama, Birmingham. scale devised by Houpt and colleagues. 7 One of the limitations of this scale is the evaluation of movement. 1. Troutman KC: Pharmacologic management of pain and anxiety for pediatric patients. In Pediatric Dentistry, Total Patient Care, Frequently, sedated patients are placed into a Papoose Wei SHYED. Philadelphia: Lea & Febiger, 1988, pp 156-86. Board with or without a head restraint, thus it becomes 2. Duncan WK, Pruhs RJ, Ashrafi MH, Post AC: Chloral hydrate difficult to determine if the degree of controlled move- and other drugs used in sedating young children: a survey of ment is the result of the medication(s) given or the use American Academy of Pedodontic Diplomates. Pediatr Dent of the Papoose Board. 5:252-56, 1983. 3. Nathan JE, West MS: Comparison of chloral hydrate-hydrox- There were minor inconsistencies between the raters in yzine with and without meperidine for managementof the diffi- their evaluations of the treatment variables for both regi- cult pediatric patient. ASDCJ Dent Child 54:437-44, 1987. mens. However, when their data were analyzed sepa- 4. Poorman TL, Farrington FH, Mourino AP: Comparison of a chlo- rately as well as combined,the statistical results were the ral hydrate/hydroxyzine combination with and without meperi- same: chloral hydrate/promethazine was the more effec- dine in the sedation of pediatric dental patients. Pediatr Dent 12:288-91, 1990. tive drug regimen. These differences maybeattributed to 5. Hasty MF, Vann WFJr, Dilley DC, Anderson JA: Conscious seda- factors such as gender or individual perceptions toward tion of pediatric dental patients: an investigation of chloral hy- sedations. One rater consistently had higher evaluations drate, hydroxyzine pamoate and meperidine vs. chloral hydrate comparedto the other rater. Other factors such as age, and hydroxyzine pamoate. Pediatr Dent 13:10-19, 1991. 6. Robbins MB:Chloral hydrate and promethazine as premedicants diplomate status, and the number of sedations done in a for the apprehensive child. ASDCJ Dent Child 34:327-31, 1967. pediatric dental practice mayalso bias a rater. The corre- 7. Houpt MI, Koenigsberg SR, Weiss NJ, Desjardins PJ: Comparison lation betweenthe raters ranged from 0.63 to 0.78 for the of chloral hydrate with and without promethazine in the sedation variables of sleep (r = 0.78), movement(r = 0.63), crying of young children. Pediatr Dent 7:4146, 1985. (r = 0.76), and overall evaluation (r = 0.75) of the sedations. 8. Dees HC: A study of the effect of Phenergan and Vistaril in combination with Demerol on labor and delivery. J Med Assoc Poormanet al.4 report the correlation of their evaluators Ga 54:301-3, 1965. was 0.4 for sleep and 0.8 for the remaining variables. The 9. Maikasian GD, Smith RA, Decker DG: Comparison of hydrox- results of this current study concludedthat the drug regi- yzine-meperidine and promethazine-meperidine for analgesia menswere effective for oral sedation in pediatric dental during labor. Obstet Gyneco130:568-75, 1967. patients. Statistically, the chloral hydrate/promethazine 10. LampshireEL:Balancedmedication. ASDJJDentChild26:25-31, 1959. regimen proved to be more effective, but clinically both 11. Album MM:Meperidine and promethazine hydrochloride for regimens were equally effective for treatment. handicapped patients. J Dent Res 40:1036-41, 1961. 12. Droter JA: Meperidine hydrochloride as a dental premedication. Conclusions Dent Surv 40(7):53-57, 1964. 1. Chloral hydrate/promethazine sedations were 13. Frankl SN, Shiere FR, Fogels HR: Should the parent remain with the child in the dental operatory? ASDCJ Dent Child 29:150-63, superior to meperidine/promethazine sedations 1962. according to the parameters of sleep, movement, 14. Guidelines for the elective use of conscious sedation, deep seda- crying, and overall evaluation (P < 0.05). tion, and general anesthesia in pediatric patients. Pediatr Dent 2. Clinically, no difference was noted between regi- 7:334-37, 1985. mens as both groups completed treatment. 15. Badalaty MM, Houpt MI, Koenigsberg SR, Maxwell KC, DesJardins PJ: A comparison of chloral hydrate and diazepam sedation in young children. Pediatr Dent 12:33-7, 1990.

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