Comparison of chloral hydrate, meperidine, and hydroxyzine to midazolam regimens for oral sedation of pediatric dental patients

PURPOSE: The purpose of this retrospective study was to compare the effects of oral administration of a combination of chloral hydrate (CH) 25 mg/kg, hydroxyzine (H) 1 mg/kg, and meperidine (M) 1 mg/kg to midazolam 0.65 mg/kg using 50% nitrous oxide (N2O) on behavioral and physiological parameters of young children sedated for dental procedures. Factors associated with sedation effectiveness were identified, including age, preoperative behavior, and type of procedure. METHODS: Records of 116 sedation sessions of 66 healthy, uncooperative children ages 24 to 60 months at The University of Iowa Centers for Disabilities and Development were reviewed. Patients received 1 of the 2 regimens. Intraoperative behavior was rated using a dichotomous scale. Physiological variables including heart rate and oxygen saturation were recorded at baseline and at 10-minute intervals of the session. Data were analyzed using SPSS Version 9. RESULTS: Overall, 81 % of sessions were rated successful. Sedation sessions using CH+H+M combination had significantly higher success rate (P<.01, odds ratio=3.38, 95% confidence interval= 1.06 to 7.15) compared to sessions with midazolam. Sedation success was not associated with age, preoperative behavior, or type of dental procedure performed. Physiological variables were within the normal range for both regimens, although midazolam regimen recorded higher heart rates. CONCLUSIONS: CH+H+M combination using 25 mg/kg CH resulted in significantly more effective sedation sessions compared to midazolam. Both regimens used 50% N2O and were found to be safe.     

Conscious sedation of pediatric dental patients: an investigation of chloral hydrate, hydroxyzine pamoate, and meperidine vs. chloral hydrate and hydroxyzine pamoate

This study evaluated two oral sedative regimens for the conscious sedation of pediatric dental patients (mean age 37.0 months) unmanageable by traditional behavior management techniques. Regimen A included chloral hydrate (Noctec--E.R. Squibb and Sons, Princeton, NJ) at 50 mg/kg with 25 mg hydroxyzine pamoate (Vistaril--Pfizer Laboratories, New York, NY), plus meperidine (Demerol--Winthrop-Breon, New York, NY) at 1.5 mg/kg. Regimen B included chloral hydrate at 50 mg/kg with 25 mg hydroxyzine pamoate. In a crossover research design, 10 patients were assigned randomly to receive one regimen, to be followed by the alternative regimen during the second appointment. The primary purpose of this study was to determine if meperidine would improve patient behavior, and increase the prevalence of respiratory compromise. A secondary purpose of the study was to develop an objective method to assess behavior during the conscious sedation of pediatric dental patients. Results revealed that the addition of oral meperidine to chloral hydrate and hydroxyzine pamoate resulted in improved behavior (P less than 0.01) during local anesthetic injection, rubber dam delivery, and the operative dental procedure. There was no increase in the prevalence of respiratory compromise with the addition of meperidine.     

Effect of submucosal midazolam on behavior and physiologic response when combined with oral chloral hydrate and nitrous oxide sedation

PURPOSE: This study was designed to examine the efficacy and safety of submucosal (SM) midazolam and oral chloral hydrate (CH) when used for pediatric conscious sedation in a clinical dental environment. METHODS: Twenty children ages 32 to 63 months participated in this institutionally approved study. Selection criteria included good health (ASA I), 2 to 5 years of age, uncooperative behavior, and the need for multiple restorative visits. In a double-blind crossover design, patients were randomly assigned to receive either oral CH (50 mg/kg) and SM midazolam (0.2 mg/kg), or oral CH (50 mg/kg) and SM saline placebo on their first sedation visit. On the second sedation visit, the patient received the opposite drug regimen than the first visit. Nitrous oxide (50%) was used during each sedation visit. Behavior response was rated as quiet (Q), crying (C), movement (M), or struggling (S) every 2.5 minutes through 40 minutes of operative procedures. Sedations were monitored using a capnograph, pulse oximeter, an automated blood pressure cuff, and precordial stethoscope. Respiratory rate (RR), heart rate (HR), and blood pressure (BP) were evaluated for each procedure. Data was analyzed using ANOVA and multinomial repeated-measures logistic regression. RESULTS: Analysis showed a significant difference in behavior during sedation across drug regimen (chi-square = 55.6, df = 3, P < .0001). Patients given SM midazolam in addition to oral CH showed increased Q rating and decreased C, M, and S ratings. RR, BP, and HR for both groups remained within the normal values for 2- to 5-year-olds. CONCLUSIONS: SM midazolam improved the quality of sedation without compromising safety. Quiet behavior was increased and struggling behavior was decreased. In addition, mean HR, RR, and BP analysis did not deviate from the norm for this age group.     

Comparison of the efficacy of oral midazolam alone versus midazolam and meperidine in the pediatric dental patient

PURPOSE: The purpose of this study was to compare midazolam alone (Group A: 1 mg/kg) vs midazolam plus meperidine (Group B: 0.5 and 1 mg/kg, respectively) in regard to physiology and behavior of young children sedated for dental restorative care. METHODS: Twenty healthy children who met selection criteria were randomly assigned to 1 of 2 groups and subsequently treated in a prospective, crossover design. All sedative agents were administered orally, and all sedations included 50% nitrous oxide administered via a nasal hood. Heart rate, systolic and diastolic blood pressure, and behavior were recorded at 8 procedural or time periods during the visits. Chi-square and ANOVA were used to analyze the data. RESULTS: No difference in physiology or behavior was found between groups. However, higher heart rates and disruptive behaviors occurred more frequently during or after local anesthesia administration. CONCLUSIONS: Oral midazolam alone is just as effective as midazolam with meperidine. Disruptive behaviors accounted for increased heart rates.     

Comparing efficacy and safety of four intravenous sedation regimens in dental outpatients.

BACKGROUND: Management of patients' fear and anxiety during dental treatment is a primary concern of dental practitioners. Pharmacological strategies used in outpatient dental settings must be both safe and effective. Regimens of intravenously administered sedative drugs were evaluated in a collaborative, multicenter study of outpatients undergoing removal of impacted third molars. METHODS: A total of 997 patients randomly received one of five treatments: placebo; midazolam administered to a clinical endpoint of conscious sedation (mean dose, 8.6 milligrams); midazolam plus additional midazolam as needed during the procedure (mean total dose, 12.2 mg); fentanyl (1.4 micrograms/kilogram) plus midazolam to achieve the same endpoint of conscious sedation (mean dose, 5.7 mg); or fentanyl (1.4 (micrograms/kg), midazolam (mean dose, 5.8 mg) and methohexital as needed during the procedure (mean dose, 61.0 mg). RESULTS: Each drug regimen reduced anxiety during surgery in comparison with placebo, with the combination of midazolam, fentanyl and methohexital resulting in significantly less anxiety in comparison with the other treatment groups. Pain reports by patients during surgery also were reduced significantly by the combination of fentanyl, midazolam and methohexital. Patients' global evaluations of the efficacy of sedation ranked midazolam with supplemental midazolam and the combination of fentanyl, midazolam and methohexital as significantly more efficacious than the other two drug regiments. The authors noted transient respiratory depression in patients in the two opioid-treated groups, but no other physiological changes were detected. CONCLUSIONS: These data provide evidence that the drugs and doses evaluated resulted in therapeutic benefit to dental outpatients, with minimal incidence of potentially serious adverse effects. CLINICAL IMPLICATIONS: The results of this large-scale study provide assurance to both the public and the dental profession of the safety of parenteral sedation with these drugs and combinations of these drugs when titrated slowly in the recommended doses by appropriately trained dentists.     

A comparison of chloral hydrate and diazepam sedation in young children

The purpose of this study was to compare a high and low dose of diazepam with chloral hydrate in the sedation of young children. Thirty healthy children between the ages of 20 and 48 months, with a mean age of 33.5 months, participated in the study. All children exhibited negative behavior during a screening visit and required at least two restorative appointments with the use of sedation. A dose of either 0.3 mg/kg or 0.6 mg/kg of diazepam at one visit and 50 mg/kg of chloral hydrate at another visit was administered in a double-blind manner. All children were restrained in a Papoose Board with auxiliary head restraint and received 50% nitrous oxide/oxygen during treatment. The degree of sleep, body movement, crying, pulse rate, respiratory rate, and blood oxygen saturation were monitored before and during the operative procedures. Vital signs remained essentially unchanged during treatment, except for transitory elevations of the pulse during periods of stimulation. There were no statistically significant differences among the three drug regimens with regard to movement and crying. Significantly more patients who received chloral hydrate were asleep than when either dose of diazepam was given during the first 60 min of treatment. The only side effect found was vomiting in one patient with both chloral hydrate and diazepam. It is concluded that the sedative effects of chloral hydrate and diazepam are similar when young children are sedated for dental treatment. The use of diazepam might be more advantageous because chloral hydrate produces more sleep during the first hour of treatment.     

Degree of sedation. Incidence of vomiting and time of postoperative sleep with 3 different oral administration schedules of hydroxyzine chlorhydrate and chloral hydrate

In this paper a comparison of sedation effectiveness, vomiting incidence and postoperative sleeping time with three sedation schemes: Chloral hydrate exclusively, hidroxicine chlorhydrate the night before and 15 minutes before chloral hydrate administration and hidroxicine chlorhydrate 15 minutes before chloral hydrate. We find that there is no significant differences between these three sedation schemes in sedation, degree of postoperative sleeping time and vomiting incidence, therefore we can expect an effective sedation degree using any of these sedation methods.     

The analgesic efficacy of valdecoxib vs. oxycodone/acetaminophen after oral surgery

BACKGROUND: The authors conducted two studies to compare the analgesic efficacy and safety of the cyclooxygenase, or COX, -2-specific inhibitor, valdecoxib, with oxycodone/ acetaminophen in patients who have undergone oral surgery. METHODS: In total, 205 eligible subjects in Study A and 201 in Study B were randomized to receive a single oral dose of valdecoxib (20 or 40 milligrams), a combination of oxycodone 10 mg/acetaminophen 1,000 mg or placebo. Eligible subjects experienced moderate-to-severe pain within six hours of surgery during which two or more impacted third molars were extracted. Analgesic efficacy was assessed over 24 hours or until the patient required rescue analgesia. RESULTS: In both studies, subjects receiving either dose of valdecoxib experienced a rapid onset of analgesia and (among those who received valdecoxib 40 mg) a level of pain relief comparable with that of those who received oxycodone/ acetaminophen. Both valdecoxib doses had a significantly longer duration of analgesic effect than did oxycodone/acetaminophen. Pooled safety data demonstrated that each valdecoxib dose had a tolerability profile superior to that of oxycodone/ acetaminophen and similar to that of placebo. CONCLUSIONS: Orally administered valdecoxib is as rapidly acting and effective as oxycodone/acetaminophen, and it has a superior duration of analgesic effect in patients after oral surgery. Valdecoxib has a tolerability profile superior to that of oxycodone/acetaminophen. CLINICAL IMPLICATIONS: The current standard of care for alleviating acute pain after oral surgery has rested largely on conventional nonsteroidal anti-inflammatory drugs or opioid/analgesic combination products. The studies reported here suggest that the COX-2-specific inhibitor valdecoxib offers an efficacious and safe alternative to other analgesics used to treat pain after oral surgery.     

Balancing efficacy and safety in the use of oral sedation in dental outpatients

BACKGROUND: Concerns about the safety of pediatric oral sedation and the incremental use of triazolam in adults prompted a workshop cosponsored by several professional organizations. OVERVIEW: There is a strong need and demand for adult and pediatric sedation services. Using oral medication to achieve anxiolysis in adults appears to have a wide margin of safety. Mortality and serious morbidity, however, have been reported with oral conscious sedation, especially in young children. Most serious adverse events are related to potentially avoidable respiratory complications. CONCLUSIONS: Clinical trials are needed to evaluate oral sedative drugs and combinations, as well as to develop discharge criteria with objective quantifiable measures of home readiness. Courses devoted to airway management should be developed for dentists who provide conscious sedation services. State regulation of enteral administration of sedatives to achieve conscious sedation is needed to ensure safety. PRACTICE IMPLICATIONS: Safety in outpatient sedation is of paramount concern, with enteral administration of benzodiazepines appearing safe but poorly documented in the office setting. Conscious sedation by the enteral route, including incremental triazolam, necessitates careful patient evaluation, monitoring, documentation, facilities, equipment and personnel as described in American Dental Association and American Academy of Pediatric Dentistry guidelines.     

A combination of chloral hydrate,meperidine, and hydroxyzine offers a safe and effective conscious sedation regimen for pediatric patients

J Evid Base Dent Pract 2002;2:212-4     

Preliminary experience with promethazine hydrochloride injection in the sclerotherapy of oral mucocele

Mucoceles are common in the minor salivary and sublingual glands. Sclerotherapy is a possible treatment strategy for mucoceles. The purpose of this study was to evaluate the clinical outcomes of sclerotherapy with promethazine hydrochloride injection in treating mucoceles. Thirty-seven patients were enrolled. Sclerotherapy was performed with promethazine hydrochloride injection (25 mg/ml) through the mucosa. Patients were followed up at 1, 3, and 6 months after the last sclerotherapy. Clinical data were reviewed. The lesions (range 2–30 mm in diameter) occurred on the ventral tongue tip (20 patients), lower lip (11 patients), and floor of the mouth (six patients). The amount of sclerosant per injection ranged from 0.2 ml to 1 ml. At the 6-month follow-up, 33 patients showed resolution with no recurrence. One patient showed a significant response with a 5-mm-diameter nodule remaining after two sclerotherapies. Three patients who underwent two or more sclerotherapies failed to show an improvement. The overall cure rate was 91.9% (96.8% for mucoceles of the minor salivary gland, 66.7% for ranulas). Complications were rare and mild. Sclerotherapy with promethazine hydrochloride injection for the treatment of mucoceles is safe. It is effective for mucoceles of the minor salivary glands, but its application for ranulas requires further investigation.     

Comparison of triazolam to a chloral hydrate/hydroxyzine combination in the sedation of pediatric dental patients

The purpose of this study was to compare the effectiveness of triazolam to chloral hydrate with hydroxyzine when sedating young children for dental treatment. Twenty children, age 21 to 74 months, with a mean age of 44 months, were given triazolam. Twenty children, age 23 to 64 months, with a mean age of 42 months, were given chloral hydrate with hydroxyzine. The children were given an elixir of either .02 mg/kg triazolam or 40 mg/kg chloral hydrate with 25 mg hydroxyzine. All subjects received 50% nitrous oxide and were restrained with a Papoose Board. The sedations were videotaped and evaluated by two pediatric dentists not involved in the study. They rated the success of the sedations by degree of sleep, crying, body movements, and overall behavior. Time until onset of action of the agents given, oxygen saturation of arterial blood, and heart rate were measured. The vital signs were consistent for the two groups. There was no statistical difference in the effectiveness of sedation between the two groups.