Comparison of temazepam elixir and trimeprazine syrup as oral premedication in children undergoing tonsillectomy and associated procedures.

Temazepam 0.5, 1.0 and 1.5 mg kg-1 in an elixir formulation (Euhypnos Elixir), was compared with trimeprazine tartrate 3 mg kg-1 in a syrup (Vallergan Forte Syrup), as premedication in 220 children (ASA grade I) undergoing tonsillectomy and associated procedures. Each patient was randomly allocated to one of the four treatments. The administration was blind to the observers in theatre, recovery room and postoperative ward, who assessed each patient according to a total of 14 criteria. A modelling technique allowed account to be taken of the effects of concomitant variables (e.g. age and duration of anaesthesia) where appropriate. No statistically significant difference was found between the efficacy of the treatments. The only statistically significant differences were that temazepam was associated with more ectopic beats under anaesthesia (P = 0.03 or 0.002, depending on the test applied), more postoperative vomiting (P = 0.04) and more postoperative restlessness (P less than 0.0001).

RCT Entities:   Population Interventions Outcomes