Comparative study of intranasal dexmedetomidine v/s midazolam for sedation of pediatric patients during transthoracic echocardiography.

Background: Procedural sedation required to improve the quality of Transthoracic Echocardiography (TTE) in infants and children. The ideal drug and route for sedation in children should have a rapid and reliable onset, atraumatic, palatable with minimal side effects, and rapid recovery. So, the aim of our study to evaluate and compare the efficacy and safety of intranasal midazolam and intranasal dexmedetomidine in pediatric patients for sedation during TTE. Materials and Method: Hundred children under three year of age, belonging to the American Society of Anaesthesiologists class-I and II, scheduled for TTE were divided into two groups by standard randomization technique. Patients in group-M received intranasal midazolam 0.2 mg/kg, whereas patients in group-D received intranasal dexmedetomidine 2 µg/kg prior to TTE under an adequately monitored anesthesia care. Onset and duration of sedation, heart rate, oxygen saturation, sonographer's, and parent's satisfaction scores were recorded. Results: All patients were successfully sedated for TTE. The average onset time, sedation time, awakening time and total time for Group-M were 7.3, 18.8, 29.51, 51 min and group-D were 10.1, 14.2, 24.9, 46.3 min, respectively and all were statistically significant (P < 0.001). TTE scan time of Group-M is 8.84 min and Group-D is 9.18 min and was statistically significant. Sonographer's and Parent's average satisfaction score for Group-M was 9.88, 10 and for Group-D was 7.64, 8.76, respectively, which were statistically significant (P < 0.001). Conclusion: Intranasal midazolam and dexmedetomidine are safe and effective for sedation in TTE. Intranasal midazolam was found to be comparatively more effective in view of onset of action, sonographers, and parental satisfaction score, while sedation time, awakening time and total duration was significantly higher as compared to intranasal dexmedetomidine.

Designing of Stable Co-crystals of Zoledronic Acid Using Suitable Coformers.

In this present study a new co-crystals of zoledronic acid with DL-tartaric acid and nicotinamide has been developed with improved solubility. Zoledronic acid is a class III drug with poor oral bioavailability due to its poor permeability and low aqueous solubility; hence an attempt has been made to improve its solubility by co-crystallization technology. Pharmaceutical cocrystals are multi-component crystals with a stoichiometric ratio of active pharmaceutical ingredients (APIs) and cocrystal coformers (CCFs) that are assembled by noncovalent interactions such as hydrogen bonds, π-π packing, and Vander Waals forces. In this study the coformers selected were DL-tartaric acid and nicotinamide based on ease of hydrogen bond formation. The co-crystal of zoledronic acid with DL-tartaric acid were prepared in three ratios (1 : 1, 1 : 2 and 2 : 1) by slow solvent evaporation method and with nicotinamide in 1 : 1 ratio by dry grinding method. The formation of co-crystal was confirmed by powder X-ray diffractometry (PXRD), differential scanning calorimetry (DSC) and Fourier transform (FT)IR. The dynamic solubility of co-crystals with DL-tartaric acid in the ratios 1 : 1, 1 : 2 and 2 : 1 increased by fold as compared to pure drug.