Intravenous ketamine plus midazolam vs. intravenous ketamine for sedation in lumbar puncture: a randomized controlled trial.

ABSTRACT

OBJECTIVE: To compare a combined dose of ketamine and midazolam versus ketamine alone in the sedation of children requiring lumbar puncture. STUDY DESIGN: A randomized, controlled study, conducted between January 2004 and December 2006. SETTING: The Pediatric Emergency Department (PED) at Ankara Training and Research Hospital, Turkey. PARTICIPANTS: A random sample of 99 children (59 boys, 40 girls) aged 2-14 years (mean age 6.5+/-3.7) undergoing lumbar puncture. INTERVENTION Participants were randomized to receive intravenous (IV) ketamine only (1 mg/kg; IVK) (n=51) or ketamine plus midazolam (1 mg/kg ketamine+0.1 mg/kg midazolam; IVKM) (n=48). MAIN OUTCOME MEASURES: The mean time to sedation and adverse events. RESULTS: The mean time to sedation was significantly shorter in the IVKM group than the IVK group (2.6+/-1.1 and 3.4+/-1.7 min, respectively; P=0.01). The parental satisfaction was significantly higher in the IVKM group (P=0.001). Also the fasting time and recovery time did not differ between groups, nor was there a significant difference in nausea/vomiting between groups. Nightmares or crying spells were more common in the IVK group than in the IVKM group (P=0.04). CONCLUSIONS: We conclude that adding midazolam to ketamine did not increase the frequency of adverse events and that the combined sedative was superior to ketamine alone in terms of speed of sedation and parental satisfaction.