BACKGROUND:Oral Transmucosal ketamine (lollipop) has been shown to be an effective, harmless preoperative medication for children. However, its efficacy was not compared with commonly used premedication drugs. We, therefore, compared the efficacy of oral transmucosal ketamine with oral midazolam for premedication in children. METHODS:Fifty-five children (2-6 years of age) were randomized to receive orally either a lollipop containing 50 mg of ketamine (the group K; n = 27) or syrup containing 0.5 mg.kg(-1) of midazolam (the group M; n = 28) before minor surgery. A five points-sedation score (1 = asleep to 5 = agitated; scores 2 and 3 were defined as 'effective') on arrival in the operating room and a three points-acceptance score of separation from the parents and a three points-mask cooperation score at induction of anesthesia (1 = easy to 3 = markedly resistant; score 3 was defined as 'poor') were used. RESULTS:Sedation scores in group K were significantly higher than those in group M (P = 0.012), and the incidence of 'effective' in sedation was significantly lower in group K than in group M (P = 0.036). The incidence of 'poor' at separation from the parents and for mask cooperation was significantly higher in group K than in group M (P = 0.017, P = 0.019, respectively). CONCLUSION: These results indicate that a relatively low dose of oral transmucosal ketamine premedication provides no benefits over oral midazolam in children.
RCT Entities:
BACKGROUND: Oral Transmucosal ketamine (lollipop) has been shown to be an effective, harmless preoperative medication for children. However, its efficacy was not compared with commonly used premedication drugs. We, therefore, compared the efficacy of oral transmucosal ketamine with oral midazolam for premedication in children. METHODS: Fifty-five children (2-6 years of age) were randomized to receive orally either a lollipop containing 50 mg of ketamine (the group K; n = 27) or syrup containing 0.5 mg.kg(-1) of midazolam (the group M; n = 28) before minor surgery. A five points-sedation score (1 = asleep to 5 = agitated; scores 2 and 3 were defined as 'effective') on arrival in the operating room and a three points-acceptance score of separation from the parents and a three points-mask cooperation score at induction of anesthesia (1 = easy to 3 = markedly resistant; score 3 was defined as 'poor') were used. RESULTS: Sedation scores in group K were significantly higher than those in group M (P = 0.012), and the incidence of 'effective' in sedation was significantly lower in group K than in group M (P = 0.036). The incidence of 'poor' at separation from the parents and for mask cooperation was significantly higher in group K than in group M (P = 0.017, P = 0.019, respectively). CONCLUSION: These results indicate that a relatively low dose of oral transmucosal ketamine premedication provides no benefits over oral midazolam in children.