PEDIATRICDENTISTRY/Copyright ©1985 by TheAmerican Academy of PediatricDentistry Volume7 Number1 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 to- gether 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 prometha- zine 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 re- ceiving 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 reli- ability 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, op- erator, and type of procedure being relatively con- stant. 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 be- tween 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.