Objectives
The optimal intranasal volume of administration (VOA) for achieving timely and effective sedation in children is unclear. We aimed to compare clinical outcomes relevant to procedural sedation associated with using escalating VOA to administer intranasal midazolam.
Methods
We conducted a randomized, single-blinded, three-arm, superiority clinical trial. Children 1 to 7 years old undergoing laceration repair requiring 0.5 mg/kg intranasal midazolam (5 mg/mL) were block-randomized to receive midazolam using one of three VOA: 0.2mL, 0.5mL, or 1mL. Procedures were videotaped, with outcome assessors blinded to VOA. Primary outcome was time to onset of minimal sedation (i.e. score of 1 on the University of Michigan Sedation Scale). Secondary outcomes included procedural distress; time to procedure start; deepest level of sedation achieved; adverse events; and clinician and caregiver satisfaction.
Results
Ninety-nine children were enrolled; 96 were analyzed for the primary outcome and secondary outcomes, except for the outcome of procedural distress, for which only 90 were analyzed. Time to onset of minimal sedation for each escalating VOA was 4.7 (95% CI 3.8, 5.4), 4.3 (95% CI 3.9, 4.9) and 5.2 (95% CI 4.6, 7) minutes, respectively. There were no differences in secondary outcomes except for clinician satisfaction with ease of administration: fewer clinicians were satisfied when using a VOA of 0.2mL.
Conclusions
There was a slightly shorter time to onset of minimal sedation when using a VOA of 0.5mL compared to 1mL, but all three VOA produced comparable clinical outcomes. Fewer clinicians were satisfied with ease of administration using a VOA of 0.2mL.