Local irritation after administration of diazepam in a rectal solution

The extent of local irritation after rectal administration of diazepam in solution was studied in 24 adults (mean weight of 70 kg). The trial was randomized using a triple cross-over design. A burning sensation was reported in 60%, 12% and 0% of subjects up to 15 min after administration of diazepam 35 mg, diazepam 10 mg and placebo, respectively. Endoscopic assessment 24 h after medication showed mechanical irritation in three subjects and local irritation probably caused by diazepam, the vehicle, or both, in four. No correlation was found between subjective complaints and objective findings. Control endoscopy 7 days after medication revealed no pathology. It is suggested that a rectal solution of diazepam in doses up to 0.5 mg kg-1 is a safe form of medication in respect of irritation of the rectal mucosa.