Comparison of Subcutaneous Injection of Normal Saline and Bacteriostatic Saline

• Status: Not yet recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jeffrey Alan Klein, MD

Criteria

Inclusion Criteria:

1. All volunteer subjects will be healthy, mature in behavior and temperament, and without mental impairment.

2. A volunteer must have signed an informed consent form prior to participation.

3. A subject must be at least 16 years of age.

4. All subjects must weigh at least 40kg = 88lb.

5. All subjects must complete a standard medical history questionnaire.

6. All subjects must agree to return for a follow-up examination, 1 day, 2 days, and 1-week post-injections.

Exclusion Criteria:

• Pregnant women are excluded.

• History of an adverse reaction to percutaneous injections, such as fainting and lightheadedness (vasovagal reactions, near syncope).

• Significant needle phobia or anxiety.

• Vasovagal reaction associated with any medical procedures or the sight of blood.

• History of having or having had a blood-born infection with HIV, Hepatitis B, Hepatitis C.

• Evidence of active skin infection.

• Pre-existing or concurrent Infections (cutaneous, urinary, pneumonia are exclusionary).

• History of radiation therapy or surgery involving the area near the proposed injection site.

• Uncontrolled or labile hypertension.