Chloral hydrate and its effects on multiple physiological parameters in young children: a dose-response study.

This study evaluated the dose-response effect of chloral hydrate (CH) used alone on several physiological parameters in 26 healthy children 21 to 42 months old. Selection criteria for the children in this institutionally approved study included: a) uncooperative behavior during an initial examination; b) a minimum of four sextants with caries involvement; c) healthy, ASA I; d) parental informed consent; e) a noncompromised airway (e.g., minimal tonsillar enlargement) and f) no known allergies. A repeated measures, Latin-square design was used in evaluating either a placebo and three dosages of CH (25, 50, 70 mg/kg) over four visits for each of eight patients or the same three dosages over three visits for each of the remaining patients. The physiological parameters included: heart and respiratory rate, systolic and diastolic blood pressure, peripheral oxygen saturation, and expired carbon dioxide. For statistical purposes, physiological parameters were analyzed during specific phases which included: baseline, topical and local anesthesia administration, at initiation of cavity preparation; and at the end of the appointment. A repeated measures ANOVA and descriptive statistics were used to analyze the data. The results indicated that the diastolic blood pressure and expired carbon dioxide were affected significantly by CH dosage (P less than 0.02 and 0.005, respectively). The findings should be tempered in light of patient behavior during the visits. Dental procedures also had an influence on cardiovascular parameters. The significance of these findings related to patient safety and behavior in these very young children is discussed.

RCT Entities:   Population Interventions Outcomes