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Local irritation after administration of diazepam in a rectal solution
H C Hansen1, H Harboe, N E Drenck
1A/S Dumex (Dumex Ltd), Copenhagen S, Denmark.
British Journal of Anaesthesia
|September 1, 1989
Summary
Rectal diazepam solution up to 0.5 mg/kg was evaluated for local irritation in adults. Most burning sensations resolved quickly, and rectal irritation was minimal, suggesting this formulation is safe for rectal mucosa.
Area of Science:
- Gastroenterology
- Clinical Pharmacology
Background:
- Rectal administration is a common route for drug delivery.
- Diazepam is frequently administered rectally for various conditions.
Purpose of the Study:
- To assess the local rectal irritation potential of diazepam solution.
- To evaluate the safety of rectal diazepam in adult patients.
Main Methods:
- Randomized triple cross-over trial involving 24 adult subjects.
- Administration of diazepam (35 mg, 10 mg) and placebo rectally.
- Subjective reporting of burning sensation and endoscopic assessment for irritation at 24 hours and 7 days.
Main Results:
- Burning sensation reported by 60% (35 mg), 12% (10 mg), and 0% (placebo) of subjects within 15 minutes.
- Endoscopy revealed mechanical irritation in 3 subjects and potential diazepam-related irritation in 4 subjects at 24 hours.
- No significant correlation between subjective complaints and objective endoscopic findings was observed.
- No pathology detected on control endoscopy at 7 days.
Conclusions:
- Rectal diazepam solution at doses up to 0.5 mg/kg appears safe regarding rectal mucosa irritation.
- The incidence of local irritation is low and transient.
- Further research may explore optimal vehicle formulations to minimize any potential irritation.