BACKGROUND AND OBJECTIVES: In our country, the abstinence syndrome has high prevalence and besides the distress prolongs the length of hospital stay. The aim of this study was to evaluate the influence of associating oral clonidine to the intravenous morphine plus midazolam continuous infusion in children submitted to mechanical ventilation. METHODS: Randomized, double blind, placebo controlled study, conducted in the PICU at the Hospital Geral of Caxias do Sul. All children (1-36 months) submitted to mechanical ventilation over 12 hours (May-2005/August-2006), which had used intravenous morphine and midazolam continuous infusion were included. They were randomized to received clonidine (5 µg/kg) or placebo associated to the sedative continuous infusion. The infusion sedative doses were at the discretion of the assistant physician. The administered doses in the previous 24 hours and the doses of intermittent sedation were daily collected. The abstinence syndrome was defined based on Finnegan Score. The groups were compared regarding the cumulative doses of sedatives, length of use of sedative continuous infusion, presence and duration of the abstinence. RESULTS: Were included 69 patients (31 in the clonidine group and 38 in the placebo group). The two groups were similar regarding the general characteristics (weight, age, gender, indication of mechanical ventilation). The midazolam and morphine doses (cumulative and intermittent doses) were not different in both groups. Completed the study 59 patients, 25 in clonidine group and 34 in placebo group. The prevalence of the abstinence was similar (72% and 75%, respectively), without difference in the recovery time neither related to the length of mechanical ventilation. CONCLUSIONS: In children submitted to mechanical ventilation using high dose of opioids and diazepinic infusion the addiction of clonidine did not decrease the daily doses neither the cumulative doses and nevertheless reduced the prevalence and the evolution of abstinence syndrome.
RCT Entities:
BACKGROUND AND OBJECTIVES: In our country, the abstinence syndrome has high prevalence and besides the distress prolongs the length of hospital stay. The aim of this study was to evaluate the influence of associating oral clonidine to the intravenous morphine plus midazolam continuous infusion in children submitted to mechanical ventilation. METHODS: Randomized, double blind, placebo controlled study, conducted in the PICU at the Hospital Geral of Caxias do Sul. All children (1-36 months) submitted to mechanical ventilation over 12 hours (May-2005/August-2006), which had used intravenous morphine and midazolam continuous infusion were included. They were randomized to received clonidine (5 µg/kg) or placebo associated to the sedative continuous infusion. The infusion sedative doses were at the discretion of the assistant physician. The administered doses in the previous 24 hours and the doses of intermittent sedation were daily collected. The abstinence syndrome was defined based on Finnegan Score. The groups were compared regarding the cumulative doses of sedatives, length of use of sedative continuous infusion, presence and duration of the abstinence. RESULTS: Were included 69 patients (31 in the clonidine group and 38 in the placebo group). The two groups were similar regarding the general characteristics (weight, age, gender, indication of mechanical ventilation). The midazolam and morphine doses (cumulative and intermittent doses) were not different in both groups. Completed the study 59 patients, 25 in clonidine group and 34 in placebo group. The prevalence of the abstinence was similar (72% and 75%, respectively), without difference in the recovery time neither related to the length of mechanical ventilation. CONCLUSIONS: In children submitted to mechanical ventilation using high dose of opioids and diazepinic infusion the addiction of clonidine did not decrease the daily doses neither the cumulative doses and nevertheless reduced the prevalence and the evolution of abstinence syndrome.