drugset / Trial / NCT05109000

Comparison of Subcutaneous Injection of Normal Saline and Bacteriostatic Saline

NCT05109000

Phase 4 Unknown 32 enrolled Jeffrey Alan Klein, MD
RandomizedSingle-groupTriple-blindSupportive care

Summary

This is a randomized, double-blind, single-center clinical trial comparing normal saline and bacteriostatic saline subcutaneous injection within a single subject. While both normal saline and bacteriostatic saline can be administered intravenously, this study aims to investigate their effects following subcutaneous injection. While benzyl alcohol (the bacteriostatic component of bacteriostatic saline) is known to have local anesthetic properties, it also is an irritant and can cause inflammation at the injection site. Based on clinical experience investigators anticipate that a normal saline injection will cause a mild stinging sensation and no subsequent inflammation. In contrast, subcutaneous injection of bacteriostatic saline will not cause stinging but will cause a mild degree of inflammation which is manifested as mild tenderness and mild ecchymosis at the site of injection.

Timeline

Start
2021-11
Primary completion
2022-01
Completion
2022-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Salt and Water Unknown 10 ml Subcutaneous
Subject sodium chloride Unknown 10 ml Subcutaneous

Indications

No indication recorded.