Local reactions to i.v. diazepam in three different formulations

Area of Science:

• Pharmacology
• Gastroenterology
• Clinical Pharmacy

Background:

• Intravenous diazepam formulations can cause local venous reactions, including pain and thrombophlebitis.
• Propylene glycol and Cremophor EL based diazepam formulations (Stesolid, Stesolid MR) have been associated with significant adverse local effects.
• Evaluating alternative diazepam formulations is crucial for improving patient tolerance and safety during medical procedures.

Purpose of the Study:

• To compare the incidence of local venous reactions following intravenous injection of three different diazepam formulations.
• To assess patient-reported pain and clinically observed thrombophlebitis for each formulation.
• To determine if a new emulsified formulation (Diazemuls) offers improved local tolerance over existing options.

Main Methods:

• A study involving 200 patients undergoing gastroscopy who received intravenous diazepam.
• Comparison of three diazepam formulations: Stesolid (propylene glycol), Stesolid MR (Cremophor EL), and Diazemuls (oil-in-water emulsion).
• Assessment of pain on injection and clinical evidence of thrombophlebitis post-injection for each group.

Main Results:

• Stesolid group: 78% pain on injection, 48% thrombophlebitis.
• Stesolid MR group: 38% pain on injection, 9% thrombophlebitis.
• Diazemuls group: 1% pain on injection, 4% thrombophlebitis, showing a significant reduction in adverse reactions.

Conclusions:

• Diazemuls, an oil-in-water emulsified diazepam formulation, demonstrates a superior safety profile regarding local venous reactions compared to Stesolid and Stesolid MR.
• The therapeutic efficacy of the formulations was comparable, highlighting Diazemuls as a preferable option for intravenous administration.
• The findings support the clinical advantage of Diazemuls for minimizing patient discomfort and complications associated with IV diazepam injections.