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Evaluation of morphine as compared to meperidine when administered to the moderately anxious pediatric dental patient Susan Merlene Roberts, DDS, MSCarolyn F. G. Wilson, DDS, MSD N. Sue Seale, DDS, MSDAlton G. McWhorter, DDS, MS

Abstract This investigation evaluated two regimensused to sedate pediatric dental patients whopreviously demonstrated uncooperative behavior. One consisted of submucosalmorphine (0.15 mg/kg), and the other, oral meperidine (2.2 mg/kg); both were administered in combination with oral (1.1 mg/kg). Patients 2-7 years old were sedated with one of the two regimensand videotaped during dental treatment. If sedation wassuccessful, the child received the other regimenat the next appointment,resulting in a total of 42 sedations in 29 children. Later, patient behavior was rated blindly by two independent observers viewing tapes of specific events during dental treatment. Fourteenof 23 (61%)patients receiving morphineand 11 19 (58%)patients receiving meperidinewere sedated successfully. Vital signs, including pulse, respirations, blood pressure, and oxygen saturation were monitored and remained stable for both groups. ANOVAfor repeated measuresshowed no significant differences for any vital sign in either groupacross time. Wilcoxon’s signed rank test revealed significant improvementfor the patients successfully treated in both groups when presedation behavior was comparedwith behavior during the events of rubber damapplication, operatiw;, restorative treatment, and exit (meperidine, P < 0.005 and morphine,P < 0.001). Improvementalso was seen in the meperidine group for the event of local (P < 0.01). Chi-square analysis showed statistically significant differences in effectiveness or safety betweenthe two regimens.(Pediatr Dent 14:306-13, 1992)

Introduction National surveys have concluded that meperidine as a dental sedation using a of "50 mg for the and alphaprodine were the most commonly used nar- average problem child." He reported that approximately cotics for conscious sedation. 1, 2 Despite its widespread 5% of the children receiving this experienced use, there are surprisingly few well-designed studies in or vomiti~n~ about 15 min after administration. the literature documenting the safety and effectiveness Other repotsr 11- describelo t eh effects of mepe ridine of orally administered meperidine. combined with cosedatives such as promethazine, Meperidine is a synthetic narcotic . The , , , and therapeutic oral dosage of meperidine for sedation is chlorpromazine. The doses of the meperidine in these 1.1 to 2.2 mg/kg (0.5 to 1 mg/lb) given orally 30 to studies ranged from 0.8-2.0 mg/kg for IM use and 0.5- min3-5 before the beginning of the procedure. 0.75 mg/lb for . Success of these Meperidine is absorbed well by all routes, but is less sedations varied from 42-100%. Although infrequent, effective when given orally because only 50% of the adverse reactions include nausea, , and in- drug escapes first-pass to enter the blood creased blood pressure and pulse. stream.6-°However, the oral route is considered by The second most commonly used narcotic, most pediatric dentists to be the route of choice when alphaprodine, was withdrawn from the market by the sedating an uncooperative pediatric dental patient, and manufacturer in 1986, and pediatric dentists have since manybelieve the oral route to be the safest and associ- been searching for a replacement for this more potent ated with the least potential for overdose. Peak activity drug. Morphine has been suggested, as it has been quite from an oral dose occurs 1-2 hr after ingestion, with effective in premedicating children in medicine. Recent maximal9 respiratory occurring after 90 min. anecdotal accounts by pediatric dentists in Texas (see Respiratory depression is in the same order of fre- footnote) indicate its current use in sedating pediatric quency and magnitude as that observed with mor- dental patients and claim high success rates. It is dis- phine. turbing to observe the increased use of morphine when Droter 10 published a report on a technique on the there are no well-designed studies to advocate a safe, use of orally administered meperidine hydrochloride effective dose for the managementof the uncooperative dental patient.

306 PEDIATRICDENTISTRY: SEPTEMBER/OCTOBER, 1992 ~ VOLUME14, NUMBER5 Morphine sulfate is a narcotic analgesic. Morphine results showed that the sedation regimen worked best has been studied in the pediatric age group far more for the 3- to 7-year-old group. His findings justify fur- than any other ; therefore, its pediatric margin of ther investigation into the use of morphinefor sedation safety, as well as its side effects, are established more of the pediatric dental patient. accurately.8 The pediatric dental practitioners using morphine in Meperidine and morphine produce the same degree Texas have selected the same types of patients they of respiratory depression when given in sedated in the past with alphaprodine. Doan reported doses, and -- when patients with biliary disease are using 0.15 mg/kg of morphine administered excluded -- both have the same contraindications. submucosally 15 min after 1.1 mg/kg promethazine Despite adverse side effects, physicians have used mor- had been administered orally. :oxygen phine quite effectively in medicating children for a was administered by nasal hood at a ratio of 50:50% variety of reasons, including relief of moderate-to-se- for 5 min before the administration of morphine, and vere acute or chronic . Morphine is used then reduced to a ratio of 20:80%for the remainder of preoperatively to sedate the patient, allay apprehen- the treatment. Whensedating patients 1.5 to 8 years old, sion, facilitate induction of anesthesia, and reduce the he reported a success rate of 85%. Hatton used the same dosage.17 Effective sedation with morphine dosage as Doan without oral promethazine, and he usually occurs 10-30 min following intramuscular (IM) routinely reversed the morphine with submucosal or subcutaneous administration. The recommended at the end of the appointment. He reported pediatric dosage of morphine sulfate is 0.1- 0.2 mg/kg that before using naloxone reversal, he had numerous (up to 15 mg) when given every 4 hr IM or subcutane- patients with nausea. Hatton reported using morphine ously.7, 17, 18 O’Hara et al. 19 compared oral morphine sedation in patients 3 to 5 years old with a success rate (0.15 mg/kg) given every 4 hr to IM meperidine (1 of 90%. kg) given every 3 to 4 hr in children during the first 48 hr Because oral meperidine is the most commonlyused after orthopedic surgery. Their assessment favored narcotic sedation technique among pediatric dentists morphine because there was a significantly higher num- and morphine injection is increasing in popularity, this ber of pain-free children during the first two postopera- study was conducted. The purposes of this study were tive days with no significant differences in the side to: 1) determine the effectiveness and safety of effects of the two regimens. meperidine in combination with promethazine in man- In the supine position, therapeutic doses of mor- aging the moderately uncooperative pediatric dental phine have no major effect on blood pressure or cardiac patient; 2) determine the effectiveness and safety of rate and rhythm. Morphine is absorbed readily from morphine in combination with promethazine in man- the GI tract, nasal mucosa, lung and after subcutaneous aging the moderately uncooperative pediatric dental or IM injection. Maximalrespiratory depression corre- patient; and 3) compare these two agents for effective- lates with the of morphine and oc- ness and safety. curs 7 min after an IV dose, 30 rain following IM injec- tion, and 90 rain after subcutaneous administratio n7,8. Methods and Materials There is only one published article in the dental Thirty patients (15 males and 15 females) treated literature dealing with the use of morphine sulfate for the graduate pediatric dental clinic at Baylor College of sedating20 the apprehensive child for dental procedures. Dentistry constituted the sample for this study. The Schneider reported nine years of data, 4,363 episodes, patients ranged in age from 31-95 months (mean 58 + from patients in his private pediatric dental practice for 2.8) and were healthy with no systemic, physical or whomhe used morphine sulfate in combination with neurologic disorders. One of the primary investigators, pamoate and nitrous oxide to alleviate a faculty memberpreviously calibrated for participa- apprehension during extensive dental procedures. The tion in numerous sedation studies, selected patients IM dose of morphine was described as "1 mg/year of based on negative behavior at a prior appointment. For age, provided the patient was not underweight." When uniformity of the patient population only patients rated used with hydroxyzine, he advocated reducing the as a 2 on the Frankl Scale zj1 were included. Twen ty- morphine dose by one-third. Nitrous oxide:oxygen was seven of the 30 patients were selected at an initial used, but no concentrations were given. All patients appointment; the remaining three were selected at a were restrained, and he occasionally supplemented the subsequent operative visit. Upon identification of a original dose of morphineif the patient becamerestless. child as a candidate for the study, the procedures, Manyof the children fell asleep during treatment, and no vital signs were monitored. He reported complica- tions including vomiting, hyperactivity, and five pa- DoanD: Personal communication,1990. tients having convulsions during treatment. Schneider’s Hatton C: Personal communication,1990.

PEDIATRIC DENTISTRY: SEPTEMBER/OcTOBER,1992 -- VOLUME14, NUMBER5 307 possible discomforts and risks, and possible benefits Initial Procedures for GroupB (Meperidine were explained fully to the parents of the subjects in- and Promethazine) volved, and their informed consent was obtained. The An oral suspension of meperidine (2.2 mg/kg) and parent was given presedation instructions that the child promethazine (1.1 mg/kg) was administered to the must be NPOfor 12 hr before the time of the appoint- patient, and behavior was rated by the primary investi- ment and informed of the need to cancel if the child was gators. The patient waited quietly for 1 hr to allow peak ill. sedation activity to occur. The patient returned to the The patients were divided randomly into two groups. operatory and the pulse oximeter and automatic blood Group A received the sedation regimen consisting of pressure cuff were reattached. Vital signs were then morphine sulfate injection (Elkins-Sinn, Inc., Cherry recorded every 10 min. Nitrous oxide:oxygen (3L:3L) Hill, NJ) and~romethazine hydrochloride (Phenergan was administered, topical anesthesia was achieved, and Syrup Fortis ~- Wyeth Laboratories, Inc., Philadel- the was injected. phia, PA) and Group B received the sedation regimen of meperidine (Demero! hydrochloride Syrup ® -- Procedure for Both Groups After Administration of Local Anesthetic Winthrop-Breon Laboratories, New York, NY) and promethazine hydrochloride. The dosage of morphine After the local anesthetic injection, the nitrous was based on a currently used technique but was con- oxide:oxygen ratio was reduced (1.5L:4.5L). A rubber sistent with the recommendedpediatric IM and subcu- dam was placed when appropriate and operative pro- taneous dosages. 7, 17-19 This dosage was chosen to cedures were performed. All operative treatments were provide a starting point in data collection on which provided by one principal investigator while the other future studies may be based. The oral route was chosen assisted at chairside and monitored the patient. for meperidine because it is the most commonlyused Procedures for Evaluating Behavior by private practitioners and All aspects of the appointment were videotaped. The dosage was consistent with recommended pediatric investigators reviewed and edited all tapes for evalua- 3-5 dosages. A crossover design was planned for all tion by two independent observers. The tapes were patients who demonstrated successful cooperation at shortened to the following brief episodes: the first visit in both groups. At the sedation appoint- ment, a pulse oximeter (N100-Nellcor® -- Nell Corp., 1. Entry (30 sec) Group A-- 15 min after the patient received promethazine, before morphine admin- Hayward, CA) and automatic blood pressure cuff (Dinamap® -- Critikon, Tampa, FL) were attached to istration; Group B -- 1 hr after the patient had the meperidine-promethazine mixture the child’s upper limbs. Baseline vital signs, including blood pressure, respirations (rate, depth, and quality by 2. Nitrous oxide:oxygen -- initial 30 sec of admin- istration visual monitoring and stethoscope), hemoglobin oxy- 3. Local anesthetic administration gen saturation (SaO2) and pulse rate, were recorded for 4. Rubber dam application all patients. 5. Operative -- (30 sec) 5 min into procedure; (30 Initial Procedures for Group A (Morphine and sec) every 10 min thereafter Promethazine) 6. Restoration placement -- (30 sec) 5 rain into Oral promethazine was administered at a dosage of procedure; (30 sec) every 10 min thereafter 1.1 mg/kg. Vital signs were monitored and recorded 7. Exit -- 30 sec. every 10 rain from that point until the patient was Care was taken to omit taped segments showing the dismissed. After 15 min, nitrous oxide:oxygen (3L:3L) delivery of to the patient and all verbal was administered for 5 min. Topical anesthetic was references to the narcotic used. placed on the mucosa above the second primary molar Standardization of Raters -- Two independent ob- on the side opposite the proposed local anesthetic injec- servers (pediatric dentists) were asked to simultaneously tion site for I rain; then the calculated dosage (0.15 rag/ view 23 short taped scenarios showing a variety of kg) of morphine was injected submucosally. The two behaviors, but record their ratings of the different pa- primary investigators rated patient behavior at the time tient behaviors separately and independently. During of the morphine injection. Nitrous oxide:oxygen was this attempt to standardize the observers, it was discov- discontinued, and the patient was allowed to sit quietly ered that the Frankl Scale was inadequate for accurately in the chair for 15 min. Nitrous oxide:oxygen was rein- describing behavior of a sedated patient. For example, stituted at 3L:3L for 5 rain. Topical anesthesia was sedated patients with rubber dams in place cannot achieved and local anesthetic was injected into the areas interact actively, and consequently, cannot be given a 4 appropriate for the planned operative procedure. on the Frankl Scale, even though their behavior maybe perfect.

308 PEDIATRICDENTISTRY: SEPTEMBER/OCTOBER, 1992 - VOLUME14, NUMBER Table1. Comparisonof Frankl scale with modifiedFrankl scale Data Interpretation -- Average ratings for each FranklScale event were used to determine Category #1 Definitely negative. Examplesof this are the child’s refusal of the effectiveness of each treatment, crying forcefully, fearful, or any overt evidenceof extreme agent in improving patient negativism. behavior at each event. Suc- Category #2 Negative. The child maybe reluctant to accept treatment and have cess was defined as the abil- someevidence of negative attitude (not pronounced). ity to complete treatment on Category #3 Positive. The child is accepting of treatment but maybe cautious. The the child without use of re- child is willing to complywith the dentist, but mayhave some straint or harsh techniques. reservation. This criterion was chosen for Category #4 Definitely positive. This child has a goodrapport with the dentist and two reasons. First, if restraint is interested in the dental procedures. had to be used following drug administration, there Modified Frankl Scale was not sufficient alteration Category #1 Definitely negative. Examplesof this are the child’s refusal of in behavior or mood for the treatment, crying forcefully, fearful, or any overt evidenceof extreme sedation to be considered negativism. successful. Second, due to Category #2 Negative. The child maybe reluctant to accept treatment and have changing attitudes which someevidence of negative attitude (not pronounced). consider restraint of children Category #3 Positive. The child is accepting of treatment but maybe cautious. The for multiple nonemergent re- child willing to complywith the dentist, but mayhave somereserva- storative appointments to be tion. He mayneed reminders to keep mouth open or hands down, and may whimper. unacceptable, necessity for restraint following sedation Category #4 Very cooperative. This child is as goodas he can be whetheractively communicatingor sitting quietly. The child showsno signs of was considered a failure. All resistance to treatment or negativism. children were managed with appropriate nonaversive techniques throughout the The Frankl Scale (Table 1) was modified to allow the appointment including T-S-D, directive guidance, ques- observers to assess the sedated child’s behavior more tioning for feeling, and reinforcement. Those children accurately. The modification affected only the positive for whom treatment had to be stopped and subse- ratings, allowing patients exhibiting perfect coopera- quently completed under general anesthesia were con- tion to receive a 4, although they did not interact with sidered to be unsuccessful sedations. For those children the operator. Since the modification did not affect the for whomthe sedative regimen was considered suc- rating used to determine the patient selection for the cessful, the average rating given for each event was study, it was felt that the modified Frankl Scale re- compared with the presedation rating of a Frankl 2 mained comparable to the original Frankl Scale. using Wilcoxon’s signed rank test to determine signifi- Using the modified Frankl Scale, the independent cant differences between events. The analyses com- observers again viewed the short taped scenarios, and pared the events for the patients within Group A and were coincident in 21/23 ratings for an interrater reli- within Group B to determine the effectiveness of the ability of 91%. The other two ratings were, however, in agents tested during the various procedural events. To the same broad category -- positive or negative. determine the differences in effectiveness between the Evaluation -- The observers then viewed the edited two sedation regimens, Mann-Whitney-U was used to study tapes in a blind study method and independently compare the ratings for each event for all successful rated each child’s behavior, at the predetermined times, patients in Group A with the same events for all suc- according to the modified Frankl Scale. The operative cessful patients in GroupB. Overall success of the seda- and restorative events had from one to seven timed tion technique was determined by the percentage of segments which were rated individually and averaged successful patients in each sedation regimen group, to give one overall rating for that event for analysis. The whereas Chi-square analysis was used to determine two observers’ ratings for each event then were aver- whether the differences in percentage of success for aged to provide a single rating for each event for each each regimen was statistically significant. child. This averaging was performed so that an isolated Vital signs were examined at the various time inter- good or bad behavior did not overly skew the rating for vals by ANOVAfor repeated measures to determine an event. any statistical differences within Groups A and B.

PEDIATRIC DENTISTRY: SEPTEMBER/OCTOBER,1992 - VOLUME14, NUMBER5 309 Results Table2. Wilcoxon’ssigned rank analysis of cooperationratings for successfulsedations This study was conducted GroupA: Morphineand PromethazineGroup to determine the effectiveness Event I MeanStan. Er. Event 2 MeanStan. Er. Behavior and safety of two regimens Pre 2 _+0 LA 2.49 + .25 No improv. currently used to sedate mod- ° erately uncooperative pedi- Pre 2 0 RD 3.71 .16 + atric dental patients. A par- Pre 2 0 Oper 3.79 .11" + tial crossover design resulted Pre 2 0 Rest 3.86 .14" + in 30 patients undergoing 44 Pre 2 + 0 Exit 3.98 + .02" + appointments. The crossover ¯ P<0.001 Pre = Ratinggiven prior to sedation;LA = Localanesthesia administration; RD = Rubber design involved 13 patients damapplication; Oper = Operativetreatment; Rest = Restoration;Exit = Exit. who received both sedation regimens. One patient was dropped from the study due to inadequate data collec- no significant differences amongthe various measure- tion, resulting in a final sample of 29 patients and 42 ments for the systolic or diastolic blood pressures or sedation appointments. pulse rates across time. Group A: Morphine and Promethazine Sedation All patients remained fully conscious and there were Regimen no adverse reactions for any patient. Morphine and promethazine were used to sedate 23 Group B: Meperidine and Promethazine Sedation patients. During morphine injection, the patient’s be- Regimen havior was rated by the investigator. Seven patients Meperidine and promethazine were used to sedate were cooperative; 16 patients were uncooperative and 19 patients. Ratings given by the investigator for behav- cried or had to be restrained to successfully complete ior during administration of the oral sedation suspen- the injection. For the treatment portion of the study, 14 sion showed 18 patients to be cooperative. One patient (61%) cooperated sufficiently to be completed in the was uncooperative and was coerced into drinking the clinic, and nine became so uncooperative that treatment solution. For the treatment, 11 (58%) cooperated suffi- was completed at a later appointment under general ciently to be completed in the clinic, and eight were so anesthesia. Twopatients never calmed downsufficiently uncooperative that treatment was completed later un- after the morphineinjection to receive local anesthetic. der general anesthesia. Of these eight patients, two The seven remaining unsuccessful patients were so were never cooperative enough to receive local anes- uncooperative for local anesthetic injection that treat- thetic, and five were so uncooperative during local ment was aborted. The patient ages of the failed seda- anesthetic injection that treatment was aborted. One tions ranged from 32-74 months (mean 51 + 4.7). patient had operative commence, but a temporary res- For the 14 patients who were able to undergo the toration had to be placed due to uncontrollable move- planned treatment, the average ratings of the indepen- ments. The patient ages of the failed sedations ranged dent observers for the five events following nitrous from 43-72 months (mean 54 + 4.1). oxide:oxygen administration were analyzed. The only For the 11 patients who were able to undergo the ratings which had to be averaged were in the operative planned treatment, the average ratings of the indepen- phase for three patients where their behavior differed dent observers for the five events following nitrous between the 5 and 15 rain ratings. The rating for each oxide:oxygen administration were analyzed. The only event was compared to the presedation rating (Frankl ratings that had to be averaged were for one patient 2) to determine the degree of improvement. Data from during the operative phase (his behavior differed at the Wilcoxon’s signed rank test (Table 2) revealed signifi- 25-rain rating) and for two patients during restoration cant improvement in behavior when the presedation placement (their behavior differed between the 5- and event was compared to all other events except local 15-min ratings). The five rated events were comparedto anesthetic injection (P < 0.001). the presedation rating (Frankl 2) to determine the de- Vital signs were evaluated and analyzed statistically gree of improvement. Data from Wilcoxon’s signed at baseline, before morphine injection, and every 10 min rank test (Table 3, page 311) revealed significant im- thereafter. Measurements recorded during the sedation provement for local anesthetic injection (P < (I.01) appointments showed that oxygen saturation never all events following local anesthesia when compared to dropped below 95%. Respiration rate showed only very the presedation behavior (P < 0.005). slight variations ( 2/min for 18 patients and 4/min for Vital signs were evaluated and statistically analyzed five patients). ANOVAfor repeated measures revealed at baseline, start of treatment (1 hr after oral meperidine),

310 PEDIATRIC DENTISTRY: SEPTEMBER/OCTOBER,1992 N VOLUME14, NUMBER5 Table3. Wilcoxon’ssigned rank analysis of cooperationratings for successfulsedations and respiration rates were GroupB: Meperidineand PromethazineGroup similar for both sedation regi- Event I MeanStan. Er. Event 2 MeanStan. Er. Behavior mens at all measurement in- tervals. Therefore, both regi- Pre 2 + 0 LA 3.05 + .24" + mens were found to be Pre 2 0 RD 3.68 .19~ + equally safe. t Pre 2 0 Oper 3.76 .18 + Discussion Pre 2 0 Rest 3.66 .27t + This investigation was de- Pre 2 + 0 Exit 3.86* -+ .10 + signed to provide data on the ¯ P < .01 ; * P < 0.005. Pre = Rating given prior to sedation; LA = Local anesthesia administration; efficacy and safety of two RD= Rubber dam application; Oper = Operative treatment; Rest = Restoration; Exit = Exit. sedative regimens currently used in pediatric dentistry. and every 10 min thereafter. Vital sign measurements One objective of this study was to contribute to the recorded during the sedation appointments showed literature a well-designed study to support a narcotic that oxygen saturation never dropped below 96%. Res- sedation technique, oral meperidine and promethazine, piration rate showed only very slight variations ( 2/ which is most commonlyused in private practice. There rain for 17 patients and 4/min for two patients). ANOVA are few controlled studies investigating an effective, for repeated measures revealed no significant differ- standardized dosage or using defined criteria for pa- ences amongthe various measurements for the systolic tient selection, success, and safety of this sedation regi- or diastolic blood pressures or pulse rates across time. men. All patients remained fully conscious; however, two An important goal in conducting this project was to patients vomited. use defined criteria for determiningsuccess of the agents. Comparison of Group A With Group B The goal of sedative regimens used in pediatric den- tistry is to improve patient behavior so that treatment All successful first appointment patients were in- can be completed. Overall success for this study was cluded in the crossover study. Originally 17 patients based on the ability of the investigator to complete the qualified, but four were unable to complete the study prescribed treatment for the child without the use of for a variety of reasons. Both sedation regimens were restraint or harsh managementtechniques. The success received by 13 patients. Four received morphine first rates of 58%for the meperidine group and 61%for the and meperidine second, and nine received meperidine morphine group are comparable to success rates re- first and morphine second. The number that received ported for some investigators for conscious sedation morphine first was so small that it was decided not to regimens in children, 12, 14, 15 but lower than others analyze the crossover group as a separate subset, but previously reported. 11 To be able to document im- rather use all patients from Groups A and B (crossover provement in behavior as a result of the sedation regi- and noncrossover) in the group comparisons. men, the patient’s behavior had to be rated at the time of The ratings given for the events of local anesthesia, selection for purposes of comparison with ratings for rubber dam, operative, restorative, and exit for all suc- sedated behavior. For uniformity, the criteria for pa- cessful patients in Group A were compared with the tient selection in our study were very stringent and ratings for successful patients in Group B (Table 4). specific. Only patients exhibiting frank evidence of in- Mann-Whitney-Uanalysis showed no statistical differ- ences for any event when the groups were compared. However, there was a trend for local anesthesia behav- Table4. Mann-Whitney-Uanalysis: cooperation ratings ior ratings of patients in Group B to be more positive betweengroups -- successfulsedations than for the patients in Group A. Event Group A GroupB Signif Overall success, as determined by the ability to com- plete treatment, was 61%(14/23) for the sedation regi- LA 2.49_+ .25 3.05_+ .24 NS men of morphine and promethazine, and 58% (11/19) RD 3.71 .16 3.68 .19 NS for the regimen of meperidine and promethazine. Chi- square analysis revealed no significant differences be- Op 3.79 .11 3.76 .18 NS tween the success rates for the two sedation regimens. Rest 3.86 .14 3.66 .27 NS Vital sign measurements of systolic and diastolic Ex 3.98_+ .02 3.86_+ .10 NS blood pressures and pulse for both regimens revealed LA = Local anesthesia administration; RD = Rubber dam application; no significant differences whenanalyzed across time by Op = Operative treatment; Rest = Restoration; Ex = Exit; Meanand ANOVAfor repeated measures. The oxygen saturation 5E; NS = Nonsignificant.

PEDIATRIC DENTISTRY: SEPTEMBER/OCTOBER,1992 ~ VOLUME14, NUMBER5 31 1 ability or unwillingness to cooperate, or a Frankl 2 be less effective than meperidine in elevating the pain rating, were candidates for the study. Although success threshold. The former is the more likely since those was based on the ability to complete treatment, statisti- patients appeared to anticipate the second injection and cal analyses of the present data (behavior ratings at five have a more difficult time accepting it. Oral administra- events) determined that there were significant improve- tion for the meperidine group seems more advanta- ments in behavior at all events for the group deemedto geous than the submucosal route for the morphine be successful. group with respect to patient behavior during subse- The alternative sedation regimen evaluated in our quent local anesthesia administration. study consisted of submucosally administered mor- In comparing the two regimens with respect to phine in combination with oral promethazine. There is changes in physiological parameters and safety, there only one study in the dental literature to which this appear to be no differences. For both groups, the heart regimen could be compared. Schneider 20 published a rate and systolic and diastolic blood pressures fluctu- nine-year study in which morphine, administered IM at ated slightly during treatment, usually in association a dose of "1 rag/year of age," was examined in a with environmental stimulation. However, statistical population of pediatric dental patients. Based on data analysis showed no significant variation between provided in Schneider’s tables, it is assumed that the baseline and treatment recordings. Hemoglobin oxy- dose averaged about 0.2 mg/kg. The dose in our study gen saturation did not drop below 95%in any patient in was somewhat lower (0.15 mg/kg), and was based either group and respiratory rate never varied more personal communication with private practitioners than 4/min. Saravia et al. 14 reported that following IM knownto the investigator (see footnote). Schneider did sedation with meperidine, promethazine, and not report a success rate for comparison to the 61% chlorpromazine, 47%of the patients experienced a de- success rate of this study. He reported complications of cline in oxygen saturation. This was not observed in our vomiting, hyperactivity, and convulsions during treat- study. ment. Due to the fact that no vital signs or local anes- Comparison of the complications associated with the thetic dosages were recorded, hypoxia and/or local two sedative regimens in the our study showed that anesthetic overdose cannot be ruled out as the cause. vomiting was a complication associated with Vital signs proved to be very stable in our study and no meperidine. Two patients vomited, one 10 ~nin after patients exhibited any complications. Schneider also administration and one after treatment was completed. reported that many of his patients slept during treat- No vomiting occurred after morphine administration. ment, whereas in this study, no patients slept at any A comparison of the success rates of the two regi- point during treatment. mensindicated that one was not superior to the other in In comparing the two regimens examined in this improving behavior. The advantages of one regimen study, the route of drug administration must be evalu- over the other, therefore, would be relative to aspects ated. Orally administered meperidine and promethazine other than successful behavior modification. Because was received cooperatively by 95% of the children. the patient can be restrained for the injection, the mor- Only 30% (7/23) of the patients receiving morphine phine may have the advantage in administration to a were cooperative during the injection while the remain- totally noncompliant patient or one who will not, or der were uncooperative and cried forcefully or had to cannot, swallow. Additionally, morphine would be ex- be restrained. Therefore, the two regimens caused very pected to have a more reliable response, because sub- different responses to the administration of the agents. mucosal administration allows for more complete up- This aspect of the study appears to be associated with take of the drug. The meperidine regimen would ap- patient acceptance of the local anesthetic injection. In pear to have the advantage of a less noxious route of the analysis of data for the ratings of the patient’s administration and, therefore, would not sensitize the behavior at each event, the event of local anesthesia was patient to the local anesthetic injection. different for the two regimens. Those patients receiving The success rates of these two drug regimens, as the submucosal injection of morphine demonstrated no determined in this study, are very similar. This is sur- improvementin behavior for the local anesthesia event prising, in that it was anticipated that morphine would when compared to the presedation rating. Therefore, have a superior success rate when considering the anec- improvement in behavior was not evident until after dotal reports. In fact, neither morphine nor meperidine this event. The local anesthetic event in the group re- can be considered a panacea. Both drug regimens were ceiving oral meperidine was significantly different in a equally safe at the recommended dosages as deter- positive direction when compared with the presedation minedby the stability of the vital signs. It is our opinion rating. It appears that the morphineinjection mayeither that, at the recommendeddosages, meperidine is pre- sensitize the patients to the local anesthetic injection or ferred to morphine for the patient who is able and

312 PEDIATRIC DENTISTRY" SEPTEMBER/OCTOBER,1992 N VOLUME14, NUMBER5 willing to swallow the sedation mixture. However, ad- 1. AubuchonRW: Sedation liabilities in pedodontics. Pediatr Dent ditional dose-response studies are needed to determine 4:171-80,1982. DuncanWK, Pruhs RJ, Ashrafi MH,Post AC:Chloral hydrate if a higher dose of morphine would increase success. and other used in sedating youngchildren: A survey of AmericanAcademy of Pedodontics Diplomates. Pediatr Dent Conclusions 5:252-56,1983. 1. The sedation regimen consisting of a combina- 3. MoorePA, GoodsonJM: Risk appraisal of narcotic sedation for children. AnesthProg 32:129-39,1985. tion of 0.15 mg/kg of morphine sulfate adminis- 4. Gilman AG, GoodmanLS, Rail TW, Murad F: Goodmanand tered submucosally and 1.1 mg/kg of Gilman’s:The PharmacologicalBasis of Therapeutics. NewYork,: promethazine administered orally was success- MacmillanPublishing Co, pp 513-16, 1985. ful 61% of the time in modifying the behavior of 5. Physicians’ DeskReference 1990. 44th ed. Oradel, NJ: Medical EconomicsCo, Inc, 1990. the moderately uncooperative pediatric dental 6. MatherLE, TuckerGT: Systemic availability of orally adminis- patient sufficiently to allow completion of treat- tered meperidine. Clin PharmacolTher 20:535-40, 1976. ment. Jaffe JH, Martin WR:Opiod and antagonists. In 2. The sedation regimen consisting of a combina- Pharmacologic Basis of Therapeutics. AG Goodman, LS Goodman,A Gilman eds. NewYork: McMillian, 1980, pp 494- tion of 2.2 mg/kg of meperidine and 1.1 mg/kg 534. of promethazine administered orally was suc- KorenG, Maurice L: Pediatric uses of . Pediatr Clin cessful 58% of the time in modifying the behav- North Am36:1141-56, 1989. ior of the moderately uncooperative pediatric 9. BrandtSK, BuggJL Jr: Problemsof medicationwith the pediatric patient. Dent Clin North Am28:563-79, 1984. dental patient sufficiently to allow completion of 10. DroterJA: Meperidinehydrochloride as a dental premedication. treatment. Dent Surv40:53-57, 1964. 3. There was no statistically significant difference 11. AlbumMM: Meperidine and promethazine hydrochloride for in the effectiveness of the two sedation regimens handicappedpatients. J Dent Res 40:1036-41,1961. 12. Tobias GM, Lipschultz DH, Album MM:A study of three studied with respect to modifying the behavior preoperative sedative combinations. J Dent Child 42:453-59, of the moderately uncooperative pediatric den- 1975. tal patient. 13. MooreRL, Carrel R, Binns WHJr: A balanced oral sedation 4. There was more negative behavior for the event technique. ASDCJ Dent Child 48:364-67, 1981. 14. Saravia ME, Currie WR,Campbell RL: Cardiopulmonary pa- of local anesthesia in the patients receiving the rameters during meperidine, promethazine, and chlorpromazine sedation regimen using a submucosal injection sedation for pediatric dentistry. AnesthProg 34:92-96, 1987. of morphine in combination with orally admin- 15. NathanJE, WestMS: Comparison of chloral hydrate-hydroxyzine istered promethazine as compared to the other with and without meperidine for managementof the difficult pediatric patient. ASDCJ DentChild 54:437-44,1987. regimen. 16. Hasty MF, Vann WFJr, Dilley DC, Anderson JA: Conscious 5. The physiologic parameters of hemoglobin oxy- sedation of pediatric dental patients: an investigation of chloral gen saturation, respiratory rate, and blood pres- hydrate, hydroxyzinepamoate, and meperidine vs. chloral hy- sure did not change significantly at any interval drate and hydroxyzinepamoate. Pediatr Dent 13:10-19, 1991. 17. Sewester CS: DrugFacts and Comparisons.St. Louis, MO:Facts for either of the sedation regimens studied. and Comparisons,1988, pp 242-50. 18. Smith RM:Anesthesia for Infants and Children. St. Louis, MO: This investigation was funded by Baylor College of Dentistry. CVMosby Co, 1980. 19. O’Hara M, McGrathPJ, D’Astrous J, Vair CA: Oral morphine Dr. Robertsis in private practice in Dallas, TX.Dr. Wilsonis associate versus injected meperidine(Demerol) for pain relief in children professor, Dr. Seale is professor and chair, and Dr. McWhorteris after orthopedicsurgery. J Pediatr Orthop7:78-82, 1987. assistant professor in the Departmentof Pediatric Dentistry, Baylor 20. Schneider HS: Clinical observation utilizing morphinesulfate College of Dentistry, Dallas, TX.Reprint requests shouldbe sent to: and hydroxyzine pamoate for sedating apprehensive children Dr. Carolyn Wilson, Baylor College of Dentistry, Department of for dental procedures:a nine-year report. Pediatr Dent8:280-83, Pediatric Dentistry, 3302Gaston Ave., Dallas, TX75246. 1986. 21. Frankl SN, Shiere FR, Fogels HR:Should the parent remain with the child in the dental operatory? J DentChild 29:15062,1962.

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