Oral midazolam premedication for children with congenital cyanotic heart disease undergoing cardiac surgery: a comparative study.

To determine whether oral midazolam is a safe and effective alternative to our current standard premedication for children with cyanotic congenital heart disease (CCHD), 30 children aged 1-6 yr, scheduled for elective cardiac surgery, were studied. The children were randomly assigned to one of two groups: Group I received oral midazolam 0.75 mg.kg-1 30 min before separation from their parents in the surgical waiting area, and Group II received oral or rectal pentobarbitone 2 mg.kg-1 at 90 min, and morphine 0.2 mg.kg-1 and atropine 0.02 mg.kg-1 im at 60 min before separation. Heart rate, haemoglobin oxygen saturation (SpO2) and anxiolysis and sedation scores were recorded at four times during the study: at baseline (immediately before premedication), immediately after administration of the premedication, at separation of children from parents in the waiting area and at the time of application of the face mask in the operating room. We found that in Group I, anxiolysis improved at separation from parents compared with baseline (P < 0.05) and sedation increased both at separation and on mask application (P < 0.05), whereas in Group II anxiolysis did not change at any time and sedation increased only at separation (P < 0.05). Intramuscular injection of morphine produced a transient decrease in mean SpO2 (from 84% to 76%) (P < 0.05) that did not occur after ingestion of oral midazolam. The results of this study indicate that oral midazolam is a safe and effective replacement for the standard premedication for children with CCHD undergoing cardiac surgery and avoids the decrease in SpO2 associated with im injections.

RCT Entities:   Population Interventions Outcomes