High-dose rectal midazolam for pediatric procedures: A randomized trial of sedative efficacy and agitation

Objectives: To compare 2 doses of rectal midazolam, used for pediatric emergency department sedation, with regard to sedative efficacy and frequency of paradoxical agitation. Methods: Children less than or equal to48 months old undergoing cutaneous procedures received midazolam by rectum, randomized in double-blind fashion to standard (0.5 mg/kg, SDM) or high (1 mg/kg, HDM) doses. Behaviors were scored on a 5-point sedation scale before and during procedures. Proportions manifesting successful sedation and postprocedure agitation were compared between the 2 doses. Results: Sixty-five patients (32 SDM, 33 HDM) underwent sedated procedures (repair of lacerations, 97%). Behavior scores improved for both groups following medication administration and at best sedation during procedure. HDM produced better sedation at time of first suture (successful sedation: 70%, SDM vs. 91%, HDM; intergroup difference = 21%; 95% confidence interval [CI] = 2, 41) and at best point during the procedure (72%, SDM vs. 97%, HDM; Delta = 25%; 95% CI = 8, 43). However, sedative efficacy declined such that only 50% and 73% of the SDM and HDM groups, respectively, had successful sedation at the worst point during the procedures. Postprocedure agitation occurred in 17% of patients (6%, SDM vs. 27%, HDM; Delta = 21%; 95% CI = 3, 39). Conclusions: Rectal midazolam improved sedation scores over preprocedure levels and was more effective with a dose of 1 mg/kg than with 0.5 mg/kg. However, inadequate sedation in 27-50% of patients and prolonged agitation in 27% of patients at higher doses counter the advantages of rectal midazolam.