Effects of hydroxyzine-midazolam premedication on sevoflurane-induced paediatric emergence agitation: a prospective randomised clinical trial.

BACKGROUND AND AIM: Anaesthesia with sevoflurane leads to a high prevalence of emergence agitation in paediatric patients. This study investigates the effects of combining hydroxyzine and midazolam on sevoflurane-induced emergence agitation in paediatric patients undergoing infraumbilical surgery with a caudal block. PATIENTS AND METHODS: Eighty-four children 1-7 years of age undergoing general anaesthesia with sevoflurane and caudal block were assigned to two groups. Children in group M (n = 42) were premedicated with 0.5 mg kg oral midazolam and children in group MH (n = 42) were premedicated with 0.5 mg kg oral midazolam and 1 mg kg hydroxyzine given 30 min before anaesthesia induction. A caudal epidural block was performed following anaesthesia induction. Induction quality, parental separation scores and emergence agitation were evaluated. Emergence agitation was evaluated with the PAED score (Paediatric Anesthesia Emergence Delirium) every 5 min during the first 30 min after admission to recovery room. Induction quality and parental separation were assessed with 4-point scores. Postoperative pain was evaluated with the 10-point Children's and Infants' Postoperative Pain Scale.
RESULTS: Median parental separation (3 vs. 2; P = 0.01), induction quality (2 vs. 2; P = 0.03) and sedation scores (3 vs. 2; P = 0.003) were significantly better in the MH group compared to the M group. Median PAED score of group M (15) was higher than that of group MH (11; P < 0.001) and the number of children with PAED scores more than 16 was also higher in group M (n = 16) compared to group MH (n = 2; P < 0.001). None of the children had a pain score more than 3 throughout the study period.
CONCLUSION: The incidence of sevoflurane-induced emergence agitation was significantly lower in children premedicated with a midazolam and hydroxyzine combination compared to those premedicated with midazolam only. Furthermore, the midazolam and hydroxyzine combination provided better premedication quality than midazolam alone.

RCT Entities:   Population Interventions Outcomes