Comparison of Chloral Hydrate with and Without Promethazine in the Sedation of Young Children

Comparison of chloral hydrate with and without promethazine in the sedation of young children

Milton I. Houpt, DDS, PhD Samuel R. Koenigsberg, DMD,MS Neil J. Weiss, DDS Paul J. Desjardins, DMD,PhD Abstract chloral hydrate effectiveness would be increased if supplemented with nitrous oxide. This study was performed to comparethe effectiveness of chloral hydrate with and without promethazine when This study compares chloral hydrate effectiveness young children were sedated for dental treatment. with and without promethzine together with nitrous Twenty-onechildren, participated in the study ranging in oxide when young children are sedated for dental age from 15 to 45 months with a meanage of 32 months. treatment. Subjects were assigned randomlyto receive either 75 mg! kg of chloral hydrate alone or 50 mg/kgtogether with 25 mg of promethazine; alternate regimens were Method administered at two appointments. (Eight children requiring three visits received 50 mg/kgchloral hydrate Subjects without promethazineat one visit. All children received Twenty-one children participated in the 50%nitrous oxide and were restrained in a Papoose study,ranging in age from 15 to 45 months with a Board® with head holder. The degree of sleep, crying, mean age of 32 months. The children were all in good body movements,blood pressure, pulse, respiration rate health, had no previous dental experience, and were and pupil size were evaluated before, during, and after selected because they required restorative dental operative procedures. Successful sedation, as evidenced by treatment with the use of sedation in at least two lack of crying and!or movementwhich interrupted appointments. treatment, was found in 89%of the children administered chloral hydrate and promethazine compared with 72% adminstered chloral hydrate alone. Vital signs remained Medication essentially unchangedthroughout all treatments. The At the first appointment, subjects randomly were only adverse side effect noted was vomiting in 14%of the assigned to receive either 75 mg/kg of chloral hydrate administrations with promethazine and 48%without. alone (Noctec a) or 50 mg/kg of chloral hydrate together with 25 mg of promethazine (Phenergan For- Sedation is recommended frequently when ex- tisb); at the second appointment the alternate regimen was administered. Eight children requiring three vis- tensive dental treatment is performed for young chil- its received 50 mg/kg chloral hydrate without pro- dren. Chloral hydrate is used commonly because of methazine during one of the three visits. In addition, its wide margin of safety and relatively few adverse all children received 50%nitrous oxide/oxygen anal- side effects. 1 Numerousinvestigators have used dif- gesia and were restrained in a Papoose Board®c with ferent dosage regimens determined by behavior, age, 2"7 head holder. The chloral hydrate was drawn into a or weight; however, varying degrees of success were disposable syringe covered with tape to prevent the obtained. Some practitioners administer promethazine together with chloral hydrate to augment the a Noctec-Squibb Co.: Princeton, NJ. sedation effect and lessen the vomiting which may b Phenergan Fortis, Wyeth Laboratories: Philadelphia, PA. occur with chloral hydrate alone.l’8 Sim9 reported that c Papoose Board -- Olympic Medical Group: Seattle, WA.

PEDIATRICDENTISTRY: March 19851Voi. 7 No. I 41 operator from knowing the amount of medication TABLE2. Rating Scale for Movement being given. Vital signs were recorded and behavior was eval- Violent movement uated by the operator. The child then was restrained interrupting treatment with his head tilted back over the lap of the seated Continuous movement operator and his arms held by a parent. The medi- makingtreatment cation was deposited in the back of the mouth in difficult amounts which allowed swallowing and prevented Controllable movement spitting. The soluti.on was squirted slowly, to avoid that doesnot interfere aspiration, and administration took approximately .5 with treatment min. The dosages of chloral hydrate ranged from 570 No movement mg to 1535 mg with a mean of 736 mg for those receiving 50 mg/kg; and a mean of 1104 mg for those receiving 75 mg/kg. The amount of promethazine was TABLE3. RatingScale for Crying fixed at 25 mg. Subjects were treated consistently either during the Score Hystericalcrying that -- 1 morning or early afternoon so that treatment time demandsattention was constant for each subject. Similar types of treat- Continuous,persistent ment were planned for each of the treatment visits. crying that makestreatment Subjects were NPO6 hr before the appointment. difficult -- 2 Following drug administration, the child remained Intermittent, mild crying with the parent in a quiet area separated from the that doesnot interfere operatory for 45 rain; behavior and onset of sleep with treatment -- 3 (defined as closure of the eyes and lack of visible No crying -- 4 movement) were evaluated. The child then was car- fled® to the operatory and placed in a Papoose Board without auxiliary head restraint. A precordial steth- TABLE4. Rating Scalefor Overall Behavior oscope, abdominal pneumatic belt, sphygmomano- meter cuff, and finger pulse transducer were attached Aborted-- no treatment and then the nitrous oxide was administered. rendered Poor-- treatmentinterrupted, only partial treatment Evaluation completed The degree of sleep, body movement, crying, blood Fair -- treatmentinterrupted, pressure, pulse, respiration rate, and pupil size were but eventually all completed evaluated before, during, and after the operative pro- Good-- difficult, but all cedures. In the operatory, ratings were made during treatment performed mouth prop insertion, administration of the local Very good -- somelimited crying or movement,e.g., anesthesia, and every 15 min thereafter. Vital signs d during anesthesia or mouth were recorded with the Beckman R511A polygraph propinsertion unit. Rating scales were used to evaluate degree of Excellent- no crying or sleep, body movements, and crying (Tables 1, 2, 3). movement In addition, at the conclusion of each session, an overall evaluation of the child’s behavior was made according to a separate rating scale. (Table 4). These ratings were performed by the principal investigator the procedure. One month later, a consensus rating (MH) who was blind to the medication given during was made by two investigators (MH and SK) from video-tapes of the procedures to establish the reliability of the rating scales. TABLE1. RatingScale for Sleep

Score Data Analysis Fully awake,alert -- 1 Drowsy,disoriented -- 2 The experiment was designed so that each subject Asleep -- 3 could serve as his own control with time of day, operator, and type of procedure being relatively constant. The independent variable was the drug regimen, d BeckmanInstruments: Somerset,NJ. that is, dose of chloral hydrate with and without pro-

42 CHLORALHYDRATE AND PROMETHAZINE SEDATION: Houpt et al. methazine. The dependent variable was the effec- of the time). The averages of the mean ratings over tiveness of sedation as measured by the degree of all the time periods for the three drug groups were crying and movement which interfered with treat- 3.53, 3.58, and 3.29. These were not statistically sig- ment. Since the rating scales used the ordinal scale nificantly different at the .05 level of significance (df of measurement with related samples, the nonpara- = 2, F = 0.25). metric Friedman two-way analysis of variance by ranks was used to compare the groups for statistically sig- Evaluation of Sleep nificant differences. In most instances, all subjects were asleep during the seven periods of evaluation. However, subjects Results were drowsy and disoriented 15% of the time, and subjects were fully awake 10%of the time. Subjects Rater Reliability who were awake most frequently were awake in the When the ratings of crying and movement made first 15 min in the operatory. There were no statisti- in the operatory were compared with the consensus cally significant differences between the various drug ratings of the two raters made one month later from groups at any single time period and no differences videotapes of the procedures, there was 90% agree- in the averages of the mean ratings over all time pe- ment between sets of ratings. riods (df = 2, F = 1.65).

Onset of Sleep Overall Evaluation There was no significant difference in the onset of The summaryof the overall evaluations for all sub- sleep between the groups receiving different drug jects is illustrated in Table 7. Most subjects experi- regimens. Seventeen of the 21 patients who received enced either excellent or very good effects of the the 75 mg chloral hydrate without promethazine and sedation. The overall evaluation was only good 20% 16 of the 21 patients who received the medication of the time (i.e., the behavior was difficult, but all with promethazine fell asleep in the reception area, treatment was performed), and the effect of the se- that is, within 45 rain of receiving the chloral hydrate. dation was only fair 16%of the time (i.e., treatment Four of the 8 patients who received the 50 mg/kg had to be interrupted although it eventually was chloral hydrate alone fell asleep in the reception area. completed). The mean ratings for drug regimens 1, Consequently, 13 patients, or 26%of the total, were 2, and 3 were 4.71, 4.76, and 4.63, respectively, and fully awake when brought into the operatory. there were no statistically significant differences between groups as indicated by the Friedman analysis Evaluation of Movement (df = 2, F = 0.71). Of those receiving the prometh- The summary of ratings of movement for all sub- azine, 90%had an overall evaluation of good or better jects in the operatory is illustrated in Table 5. In most as compared with 80% and 75% of those receiving instances, subjects exhibited no movementor mini- either the higher or lower dose of chloral hydrate mumcontrollable movement which interfered with alone. the procedure. In some instances movement was continuous making treatment difficult. Violent move- Vital Signs ment which interrupted treatment occurred less than There were few changes in the vital signs through- 1% of the time. The averages of the mean ratings out the procedure. Blood-.pressure remained un- indicated that patients in the three drug groups moved changed and pulse rate exhibited a transitory increase little, if at all (meanratings for drug groups 1, 2, and linked to specific occurrences when the child was either 3 = 3.59, 3.50, and 3.55, respectively). There were awake or in a very light plane of sleep. For example, no statistically significant differences between the it occasionally increased when the mouth prop was groups when tested with the Friedman two-way inserted, when the rubber dam was being applied, analysis of variance by rank at the .05 level of signif- or during periods of vomiting. This increase was only icance (df = 2, F = 0.95). transitory and quickly returned to normal when the stimulus ended. These changes did not occur more Evaluation of Crying frequently with any particular drug regimen. Table 6 illustrates the summaryof ratings of crying Respiratory rate changes occurred in approxi- for all subjects in the operatory. Most subjects did mately 10% of the subjects at some time during their not cry or cried mildly and intermittently and did not procedures. These changes were similar to the changes interfere with the procedure. Continuous, persistent in pulse rate occurring at a time of a particular stim- crying making treatment difficult was infrequent (10% ulus. Constriction of the pupils was found to be re- of the time) and rarely was there hysterical crying lated to the patient’s degree of sleep, in that when that demandedthe operator’s attention (less than 1% the patient was asleep, the pupils were constricted

PEDIATRICDENTISTRY: March 1985/Vol. 7 No. 1 43 TABLE5. Summaryof Ratings of Movementfor All Subjects 1 2 3 4 Violent Continuous Controllable No Mean** Time Regimen Movement Movement Movement Movement Ratin~ During mouth I 1 ( 5)* 6 (29) 14 (67) 3.62 prop insertion II 1 5) 3 (14) 8 (38) 9 (43) 3.19 III 1 (13) 7 (88) 3.75 During I 8 (38) 13 (62) 3.62 injection II 1 5) 3 (14) 3 (14) 14 (67) 3.43 III 1 (13) 7 (88) 3.75 60 minutes post- I 1 5) 1 (5) 4 (19) 15 (71) 3.57 administration II 3 (14) 5 (24) 13 (62) 3.48 III 1 (13) 3 (38) 7 (88) 3.25 75 minutes post- I 1(5) 2 (10) 3 (14) 15 (71) 3.52 administration II 2 (10) 3 (14) 16 (76) 3.67 III I (13) 1 (13) 6 (75) 3.50 90 minutes post- I 1 (5) 5 (24) 15 (71) 3.67 administration II 1 (5) 4 (19) 16 (76) 3.71 III 1 (13) 2 (25) 5 (63) 3.38 105 minutes post- I 1(5) 1 (5) 4 (19) 15 (71) 3.57 administration II 1 (5) 10 (48) 10 (48) 3.38 III 2 (25) 6 (75) 3.50 120 minutes post- I 1 (5) 1 (5) 4 (19) 15 (71) 3.57 administration II 8 (38) 13 (62) 3.62 III 1 (13) 7 (88) 3.75 PooledRating *** I 3.59; II 3.50; III 3.55

* Numberof subjects receiving this rating, bracketednumber = percentageof total (maynot equal 100per cent dueto rounding). **Meanrating over all subjects. ***Pooledrating of all subjectsover all times.

RegimenI: 75 mg/kgchloral hydrate; RegimenI1:50 mg/kgchloral hydrate with 25 mgpromethazine; Regimen II1:50 mg/kg chloral hydrate. with little reaction to light. However, if the patient drew from the study after the first treatment session) was awake, the pupils were normal and reactive to developed petechiae on her forehead and the upper light. Rarely, a patient became excited and the pupils part of her face during drug administration due to were dilated and reactive to light. These changes in screaming and the degree of restraint necessary. No pupil size were similar to those observed in an un- other symptoms became evident and the petechiae sedated1° child during sleep. disappeared the following day. Most practitioners who sedate children for dental procedures monitor the depth of sedation by observ- Adverse Effects ing chest movement in accordance with the child’s The most frequently occurring adverse effect was respiration. In this study, respiration was monitored vomiting. It occurred in 48% and 38% of the patients with one sensor attached to the chest to monitor chest receiving the high .and low doses of chloral hydrate movements and a second sensor attached to the in- alone compared with only 14% of those receiving halation unit to monitor gas exchange. The monitor chloral hydrate with promethazine. This difference on the inhalation unit was used to detect possible was statistically significant at the .05 level of signifi- obstructions which would restrict respiration. Be- cance when tested with the chi-square analysis. Spit- cause both monitoring methods were used, an inci- ting up the medication immediately after dental finding was observed -- gas exchange was administration OCCUlTedapproximately 20% of the time reduced although chest movements continued un- with drug regimens 1 and 2, but did not occur with changed (Fig 1). This occurred when the mandible drug regimen 3. Three patients became febrile some inadvertently was depressed and a transitory partial hours after returning home; in two the fever was only blockage of the airway was produced (for example, transitory and the third developed a bad cold and when a stainless steel crown was being fitted or when was ill for a few days. One other patient (who with- the mouth prop was inserted). Figure 1 illustrates

44 CHLORALHYDRATE AND PROMETHAZlNESEDATION: Houpt et al. TABLE6. Summaryof Ratings of Crying for all Subjects

1 2 3 4 Hysterical Continuous Intermittent No Mean** Time Re~imen Cryin~ Cryin~ Crying Crying Ratin~__ During mouth 1 ( 5)* 6 (29) 14 (67) 3.62 prop insertion II 1 (5) 4 (19) 5 (24) 11 (52) 3.24 III 1 (13) 2 (25) 5 (63) 3.38 During 1 (5) 9 (43) 11 (52) 3.48 injection II 5 (24) 4 (19) 12 (57) 3.33 III 1 (13) 1 (13) 6 (75) 3.50 60 minutes post- 1 (5) 5 (24) 15 (71) 3.62 administration II 5 (24) 2 (10) 14 (67) 3.43 III 2 (25) 1 (13) 1 (13) 4 (50) 2.88 75 minutes post- 3 (14) 3 (14) 15 (71) 3.57 administration II 1 (5) 1 (5) 4 (19) 15 (71) 3.57 III 2 (25) 6 (75) 3.25 90 minutes post- 2 (10) 8 (38) 11 (52) 3.43 administration II 3 (14) 2 (10) 16 (76) 3.62 III 1 (13) 3 (38) 4 (50) 3.25 105 minutes post- 2 (10) 5 (24) 14 (67) 3.57 administration II 1 (5) 8 (38) 12 (57) 3.52 III 1 (13) 3 (38) 4 (50) 3.25 120 minutes post- 1 (5) 2 (10) 5 (24) 13 (62) 3.43 administration 2 (10) 4 (19) 15 (71) 3.62 1 (13) 1 (13) 6 (75) 3.50 PooledRating *** I 3.53; II 3.48; Ill 3.29

* Numberof subjectsreceiving this rating, bracketednumber = percentageof total (maynot equal100 per cent dueto rounding). **Meanrating overall subjects.***Pooled rating of all subjectsover all times.

RegimenI: 75 mg/kg chloral hydrate; RegimenI1:50 mg/kgchloral hydrate with 25 mgpromethazine; Regimen II1:50 mg/kg chloral hydrate.

TABLE7. Summaryof Ratings of Overall Behavior for All Subjects

1 2 3 4 5 6 Very Mean** Regimen Aborted Poor Fair Good Good Excellent Rating I 4 (19)* 2 (10) 11 (52) 4 (19) 4.71 II 2 (10) 6 (29) 8 (38) 5 (24) 4.76 III 2 (25) 2 (25) 1 (13) 3 (38) 4.63

* Numberof subjectsreceiving this rating. **Meanrating over all subjects.

Numberin brackets= percentof total (maynot equal 100per cent dueto rounding).

RegimenI: 75 mg/kgchloral hydrate; RegimenI1:50 mg/kgchloral hydrate with 25 mgpromethazine; Regimen II1:50 mg/kg chloral hydrate. that chest movements continued although there was promethazine when supplemented with 50% nitrous reduced air exchange. oxide in the degree of sedation. Of the sedations with the first regimen, 80% were judged as good or better, Discussion as compared with 90% of the sedations with the second regimen. A dosage of 50 mg/kg of chloral hydrate The results of this study indicate that there was no alone produced similar effectiveness, i.e., 75% of the significant difference between 75 mg/kg of chloral hy- sedations were judged as good or better, although drate and 50 mg/kg of chloral hydrate with 25 mg of the small number of subjects with this regimen makes

PEDIATRICDENTISTRY: March 1985/Vol. 7 No. 1 45 tration of 50% nitrous oxide was used with all patients in order to keep the nitrous oxide concentration constant; it is possible that a lower concentration would have reduced the frequency of vomiting. It is also possible that with a lower concentration — or with no nitrous oxide — greater differences in effectiveness of the various drug regimens would have be- come evident. Additional study of the drug regimens without nitrous oxide should be performed. The incidental finding of partial blockage of the airway during treatment was important. Although the clinical significance of transitory reduction in the respiration is not known, it should be assumed that children who are sedated for dental treatment must be monitored carefully in order to detect airway blockage. Further study should investigate the implica- tions of such transitory obstruction of the airway. FIG 1. Sample recording to monitor respiration of patient. Dr. Houpt is a professor and chairman, and Dr. Koenigsberg is an The lower sample recorded chest movements, whereas associate professor, Department of Pediatric Dentistry; Dr. Des- the upper sample monitored gas flow through the airway. jardins is an assistant professor, Department of Biodental Sciences, Note that when there was partial airway blockage with University of Medicine and Dentistry of New Jersey, New Jersey decrease in gas flow, the record of chest movements con- Dental School, 100 Bergen St., Newark, NJ 07103. tinued with similar amplitude and frequency. 1. Duncan WK, Ashrafi MH, Pruhs RJ, Post AC: Chloral hydrate and other drugs used in sedating young children: a survey a comparison to the other regimens somewhat in- of American Academy of Pedodontics Diplomates. Pediatr appropriate. The use of promethazine significantly Dent 5:252-56, 1983. decreased vomiting and, consequently, it is recom- 2. Barr ES, Wynn RL, Spedding RH: Oral premedication for the problem child: placebo and chloral hydrate. J Pedod 1:272- mended whenever chloral hydrate is used to sedate 80, 1977. young children for dental treatment. 3. Czarnecki ES, Binns WH: Use of chloral hydrate for the ap- These results were somewhat better than those ob- prehensive child. Penn Dent J 30:40-42, 1963. tained by Sheskin in a similar study of chloral hydrate 4. Chalmers DL, Galbreath JC: A comparison of dose effect of preoperative medication in children. Texas Dent J 84:4-6, 1966. without promethazine. However, in that study, the 5. King DL, Berlocher WC: Premedication in pedodontics — at- auxiliary head restraint connected to the Papoose titudes and agents. Pediatr Dent 1:251-57, 1979. Board® was not used, and this might have accounted 6. Smith RC: Chloral hydrate sedation for handicapped chil- for the lack of effectiveness of the sedation due to dren: a double-blind study. Anesth Prog 24:159-68, 1977. movement of the child. It would appear that there is 7. Tobias M, Lipshultz DH, Album M: A study of three preoperative sedative combinations. J Dent Child 42:453-59, 1975. a distinct advantage in using the head restraint rather 8. Robbins MB: Chloral hydrate and promethazine as preme- than the Papoose Board® alone. The head restraint dicants for the apprehensive child. J Dent Child 34:327-31, not only prevents some undesirable movement, but 1967. it also facilitates the delivery of nitrous oxide by keep- 9. Sim JM: Chloral hydrate, in Behavior Management in Den- ing the nasal hood directly over the nose. tistry for Children, Wright GZ, ed. Philadelphia; WB Saun- ders Co, 1975 pp 165-69. Nitrous oxide was used in this study because of its 10. Moses RA, ed: Adler's Physiology of the Eye: Clinical Appli- current use in pediatric dentistry. A uniform concen- cations, 6th ed. St Louis; CV Mosby Co, 1975 p 332.

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46 CHLORAL HYDRATE AND PROMETHAZINE SEDATION: Houpt et al.