UnknownPhase 4

Comparison of Subcutaneous Injection of Normal Saline and Bacteriostatic Saline

United States32 participantsStarted 2021-11

Plain-language 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.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. All volunteer subjects will be healthy, mature in behavior and temperament, and without mental impairment.
. A volunteer must have signed an informed consent form prior to participation.
. A subject must be at least 16 years of age.
. All subjects must weigh at least 40kg = 88lb.
. All subjects must complete a standard medical history questionnaire.
. All subjects must agree to return for a follow-up examination, 1 day, 2 days, and 1-week post-injections.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Injection Pain

Timeframe: Time Post-Injection: 0 minutes

Erythema

Timeframe: Time Post-Injection: 5 minutes

Erythema

Timeframe: Time Post-Injection: 1 hour

Erythema

Timeframe: Time Post-Injection: 24 hours

Erythema

Timeframe: Time Post-Injection: 48 hours

Erythema

Timeframe: Time Post-Injection: 7 days

Bruising

Timeframe: Time Post-Injection: 5 minutes

Bruising

Timeframe: Time Post-Injection: 1 hour

Trial details

NCT IDNCT05109000

SponsorJeffrey Alan Klein, MD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01

Contact for this trial

Claire M Richards

9493904965 crichards7899@yahoo.com

View on ClinicalTrials.gov More Injection Site Irritation trials

Plain-language summary

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. All volunteer subjects will be healthy, mature in behavior and temperament, and without mental impairment.
. A volunteer must have signed an informed consent form prior to participation.
. A subject must be at least 16 years of age.
. All subjects must weigh at least 40kg = 88lb.
. All subjects must complete a standard medical history questionnaire.
. All subjects must agree to return for a follow-up examination, 1 day, 2 days, and 1-week post-injections.

What they're measuring

Injection Pain

Timeframe: Time Post-Injection: 0 minutes

Erythema

Timeframe: Time Post-Injection: 5 minutes

Erythema

Timeframe: Time Post-Injection: 1 hour

Erythema

Timeframe: Time Post-Injection: 24 hours

Erythema

Timeframe: Time Post-Injection: 48 hours

Erythema

Timeframe: Time Post-Injection: 7 days

Bruising

Timeframe: Time Post-Injection: 5 minutes

Bruising

Timeframe: Time Post-Injection: 1 hour