A randomized clinical trial of triazolam in 3- to 5-year-olds.

Triazolam has shown promise as a sedative agent for use in pediatric dentistry. However, the efficacy of triazolam has not been previously examined in a placebo-controlled study. The present clinical trial used a two-group, randomized, double-blind study design to compare the efficacy of oral triazolam with that of a placebo. The primary hypothesis tested was that triazolam would reduce negative behaviors of pediatric dental patients compared with a placebo. A secondary hypothesis was that triazolam would increase the efficiency of dental treatment by reducing the need for time-consuming behavior management by the pediatric dentist. The subjects were 54 3- to 5-year-old children, randomly assigned to the drug and placebo groups. The active drug, 0.03 mg/kg triazolam (Halcion), or lactose placebo was given orally 30 min before dental treatment. Behavior management techniques commonly used in pediatric dentistry were used during dental treatment. A single pediatric dentist provided all of the dental treatment. The procedure included an inferior block anesthesia and careful attention to anesthesia effectiveness. All sessions were video-taped and the tapes coded for child and dentist behaviors by an independent observer. There were no statistically significant differences between the groups with respect to completion of dental treatment. There were no significant differences found in either the total time or the percent of time that the subjects exhibited disruptive movements, verbal or non-verbal distress. The total use of time in the dental chair was slightly higher in the placebo than in the drug group due to more time spent preparing the child. Contrary to preliminary reports in the literature, this investigation found little or no improvement in child behavior when triazolam was used as a sedative compared with a placebo. However, triazolam did shorten the length of dental treatment, primarily by reducing dentist time in preparing the child for the dental procedure (e.g., establishing rapport and shaping behavior).

Diverting managed care Medicaid patients from pediatric emergency department use.

OBJECTIVE: To evaluate the health outcomes of managed care Medicaid children with non-emergent conditions who were not authorized to be seen in the Pediatric Emergency Department (PED) by their primary care provider. DESIGN: Consecutive case surveillance from 6/29/92 to 2/2/93. SETTING: University based PED (17,500 visits/year) in inner city Baltimore. PARTICIPANTS: Cases were MAC children denied authorization to be seen for non-emergent conditions in the PED. Age and complaint matched MAC children were selected from the university based Pediatric Ambulatory Center (PAC) and from non-emergent PED visits (PED-seen) in order to compare utilization rates after denial. INTERVENTION: The Maryland Access to Care (MAC) Medicaid program (started in 12/91) emphasizes primary care and appropriate health care utilization by incorporating the following elements of managed care: assignment to primary care provider, gatekeeping, mandatory enrollment and fee for service. METHODS: Consecutive case surveillance from 6/29/92 to 2/2/93 was used to evaluate the health outcomes of MAC children denied authorization for non-emergent care in a university based PED. One week following denial, a pediatric nurse practitioner contacted the patient's caretaker and the MAC provider to ascertain health outcome. Medicaid claims data was used to compare the six month health care utilization of the denied group to age and complaint matched children seen in the PED (PED-seen) or in a primary care clinic (PAC). RESULTS: 216 MAC patients were not authorized for a PED visit by their MAC providers. 123 (57%) saw their MAC provider within one week of the denied PED visit. 40 (18%) were not seen because their presenting complaint had resolved completely. No adverse health outcomes occurred because of delay in health care delivery. The subsequent ER utilization rate of the denied group was the same as the PED-seen comparison group, and significantly higher than that of the PAC group (P = .002). The denied group was hospitalized at a significantly higher rate relative to these comparison groups (P = .003). CONCLUSIONS: Diverting Medicaid children classified as non-emergent in an ER to their MAC providers can be a safe practice short-term. However, denial of a PED visit has no impact on subsequent ER utilization by Medicaid participants and may be associated with higher hospitalization rate. Gatekeeping in this setting does not necessarily change the health care seeking behavior of these patients.

Safety and immunogenicity of human rotavirus vaccine strain M37 in adults, children, and infants.

Rotavirus vaccine strain M37 (serotype 1), recovered from the stool of an asymptomatic newborn infant and serially passaged in cell culture, was given orally to adults, children, and infants. Serologic responses were detected by neutralization assay or EIA in 59% of 17 adults (10(5)-pfu dose), 55%-60% of 21 infants and children (10(4)-pfu dose), and 70% of 10 infants (10(5)-pfu dose), vaccine virus was shed by 24%, 20%-36%, and 70%, respectively. In adults, neutralizing antibody rises to strain M37 and the related serotype 1 strain Wa occurred with equal frequency (41% vs. 47%). In pediatric subjects, the former were more frequent (36%-40%) than the latter (10%-18%). This was also true of 8 infants who received two doses of vaccine. Mild gastrointestinal illnesses occurred with equal frequency in pediatric subjects who received vaccine or placebo. Thus, strain M37 was well tolerated and immunogenic in young infants, but elicited primarily vaccine-strain-specific rather than serotype-specific neutralizing antibody responses.

The A/Mallard/6750/78 avian-human, but not the A/Ann Arbor/6/60 cold-adapted, influenza A/Kawasaki/86 (H1N1) reassortant virus vaccine retains partial virulence for infants and children.

Characteristics of avian-human (ah) and cold-adapted (ca) influenza A/Kawasaki/9/86 (H1N1) reassortant vaccine viruses were compared in 37 seronegative adults and 122 seronegative infants and children. The 50% human infectious dose (HID50) in infants and children was 10(2.9) and 10(2.6) TCID50 for the ah and ca vaccine, respectively. The ah influenza A/Kawasaki/9/86 reassortant was reactogenic: 24% of infants and children infected with greater than or equal to 100 HID50 had fever greater than or equal to 39.4 degrees C. Since H3N2 ah vaccines were previously shown to be adequately attenuated, it is reasonable to suggest that the genes that code for hemagglutinin and neuraminidase of the H1N1 virus apparently influence the reactogenicity of reassortant viruses derived from the avian influenza A/Mallard/New York/6750/78 donor virus. Because this avian virus does not reproducibly confer a satisfactory level of attenuation to each subtype of influenza A virus, it is not a suitable donor virus for attenuation of wild-type influenza viruses. In contrast, the ca A/Ann Arbor/6/60 donor virus reliably confers attenuation characteristics to a variety of H1N1 and H3N2 influenza A viruses.