JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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Premedication with oral midazolam with or without parental presence.

BACKGROUND AND OBJECTIVE: In this study, we aimed to investigate whether the combination of low-dose (0.25 mg kg(-1)) midazolam premedication with parental presence can effectively reduce anxiety at induction as well as provide a smoother emergence.

METHODS: Institutional ethics committee approval and informed consent from one of the parents were obtained prior to the study. Sixty ASA grade I or II children undergoing surgery were enrolled in the study. Children were randomized to receive either 0.5 mg kg(-1) midazolam orally (group M) or 0.25 mg kg(-1) midazolam orally with parental presence (group MP) or parental presence alone (group P). The child's anxiety and sedation scores were evaluated as 1-4 points on the Anxiety Scale and as 0-4 points on the University of Michigan Sedation Scale (UMSS), respectively, at the entrance to the operating room and for tolerance to the face mask. Heart rate, the mean arterial blood pressure and O2 saturation (%) were assessed at repeated intervals before and after induction. At the end of surgery, the child's Anxiety Scale score, UMSS score, Observer's Pain Scale (OPS) score and FLACC score were also assessed.

RESULTS: There were no differences between groups in demographic variables and duration of surgery or anaesthesia. Mean blood pressure changes were similar between groups at measured intervals, but the heart rate was higher in group M before and after induction of anaesthesia (P<0.05). UMSS score was greater in both midazolam groups (groups M and MP) in the preoperative period (P<0.05). Anxiety Scale scores for anxiolysis were higher in groups M and MP than in group P (less anxious and more sedated) at 20 min after premedication, at the entrance to the operating room and at mask tolerance time points (P<0.05). During recovery there was no significant difference in sedation, recovery scores or behavioural anxiety assessment between groups, Anxiety Scale score, UMSS score, FLACC score, Visual Analog Scale (VAS) score and Observer's Pain Scale score in groups MP, M and P.

CONCLUSION: Preoperative administration of midazolam 0.5 mg kg(-1) for premedication alone, without parental presence at induction, and that of low-dose midazolam 0.25 mg kg(-1) for premedication with parental presence at induction are both equally effective in reducing separation anxiety and providing a smooth emergence. However, parental presence alone, without midazolam for premedication, is not an adequate approach for this outcome. If the environment for parental presence is convenient, the dose of midazolam may be reduced and induction and emergence conditions may still be of high quality.

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