Double-blind Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department.

OBJECTIVE: The objective of this study was to compare anxiolysis with intranasal dexmedetomidine, an alpha-2 agonist, versus intranasal midazolam for pediatric laceration repairs.
METHODS: We performed a double-blind, randomized controlled trial of 40 patients 1-5 years with lacerations requiring suture repair in an academic pediatric emergency department (ED). Patients were randomized to receive either intranasal dexmedetomidine or intranasal midazolam. Our primary outcome measure was the anxiety score at the time of patient positioning for the laceration repair. We chose this time point to isolate the anxiolysis from the medications prior to intervention. Patient encounters were videotaped and scored for anxiety at multiple time points using the modified Yale Preoperative Anxiety Scale. The scale is 23.3-100 with higher scores indicating higher anxiety. We also evaluated these scores as a secondary outcome by dichotomizing them into anxious versus not anxious with a previously validated score cutoff.
RESULTS: Of the 40 patients enrolled, 20 in the dexmedetomidine group and 18 in the midazolam group completed the study and were included in the analysis. The median age was 3.3 years (range = 1.0-5.4 years). The median baseline anxiety score was 48.3. The anxiety score at position for procedure for patients receiving dexmedetomidine was 9.2 points lower than those receiving midazolam (median difference = 9.2, 95% confidence interval = 5 to 13.3; median score for dexmedetomidine = 23.3, median score for midazolam = 36.3). The proportion of patients who were classified as not anxious at the position for procedure was significantly higher in the dexmedetomidine group (70%) versus the midazolam group (11%). The number needed to treat with dexmedetomidine instead of midazolam to obtain the result of a not anxious patient at this time point was 1.7 patients. There were also significantly more patients who were classified as not anxious at the time of wound washout in the dexmedetomidine group compared to the midazolam group (35% vs. 6%). Dexmedetomidine and midazolam performed similarly with respect to all other measures including anxiety at other time points, parental perceived anxiety, parent and proceduralist satisfaction, procedural success, complications, and time in the ED. There were no serious adverse events seen in either group.
CONCLUSIONS: Intranasal dexmedetomidine is an alternative anxiolytic medication to intranasal midazolam for pediatric laceration repairs, performing similarly in our study, except that patients who received dexmedetomidine had less anxiety at the time of positioning for procedure.

RCT Entities:   Population Interventions Outcomes