A study to compare the effectiveness of temazepam and a chloral hydrate/hydroxyzine combination in sedating paediatric dental patients.

Author(s): Tsinidou KG, Curzon ME, Sapsford DJ

Affiliation(s): Department of Paediatric Dentistry, University of Leeds, UK.

Publication date & source: 1992-12, Int J Paediatr Dent., 2(3):163-9.

Publication type: Clinical Trial; Randomized Controlled Trial

The study compared the effectiveness of temazepam and a mixture of chloral hydrate and hydroxyzine in sedating 20 young children aged 20 to 60 months (mean age 38.7 months). All the children exhibited negative behaviour during a screening visit and required at least two visits for restorative treatment with the use of sedation. The children were assigned randomly to receive either 50 mg/kg of chloral hydrate with 25 mg of hydroxyzine or 0.3 mg/kg of temazepam for the first visit, and the alternate regimen for the second visit, in a double-blind manner. Pulse rate and blood oxygen saturation levels were monitored before, during and after the operative procedures. All the treatment sessions were video-recorded and evaluated independently by three paediatric dentists for the degree of crying, movement, sleep and overall behaviour during specific procedures and at specific time intervals. The results showed no statistically significant differences between the two pharmacologic regimens with regard to crying, movement, sleep and overall behaviour. No significant difference in behaviour was found related to either the order of administration of the drugs or to the sex of the patients. It was concluded that 0.3 mg/kg temazepam and a mixture of 50 mg/kg chloral hydrate with 25 mg hydroxyzine had similar sedative effects on the children receiving dental treatment.