Sedation With Oral Dexmedetomidine Premedication in Pediatric Patients With Acute Lymphoblastic Leukemia Undergoing Blood Sampling: A Randomized, Double-Blind Clinical Trial.

BACKGROUND

Dexmedetomidine, an α2 agonist, offers sustained, reversible sedation with anxiety and pain relief and reduces respiratory depression risk. This study assessed oral dexmedetomidine's efficacy and safety in pediatric acute lymphoblastic leukemia (ALL) patients during blood draws.

METHODS

This randomized, double-blinded, prospective clinical trial involved 60 pediatric patients aged 2-18 years diagnosed with ALL in the maintenance phase. Subjects were randomly assigned to either the intervention group, receiving 1.5 µg/kg oral dexmedetomidine mixed in apple juice, or the control group, receiving apple juice only. Sedation depth, as measured by the Richmond Agitation-Sedation Scale (RASS), pain intensity, as assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) scale and Numeric Rating Scale (NRS), and hemodynamic parameters (heart rate, blood pressure, and SpO2) were evaluated at baseline, and at 10-, 20-, and 30-min post-administration.

RESULTS

No statistically significant differences were observed between the two groups with respect to age or weight. Oxygen saturation and blood pressure were similar across all time points. A statistically significant decrease in heart rate was noted at 30 min in the dexmedetomidine group (p = 0.002). Furthermore, pain intensity during blood sampling was significantly lower in the intervention group (p < 0.001). RASS scores at 20 and 30 min indicated a greater degree of sedation in the dexmedetomidine group.

CONCLUSION

Oral dexmedetomidine effectively reduced pain and anxiety during blood draws in pediatric leukemia patients without significant adverse effects, suggesting its safety and efficacy as a pre-procedural sedative.