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Comparison of Subcutaneous Injection of Normal Saline and Bacteriostatic Saline

NCT05109000 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-11-05

No results posted yet for this study

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.

Conditions

  • Injection Site Irritation
  • Injection Site Bruising
  • Injection Site Discomfort
  • Benzoic Acid Adverse Reaction
  • Anesthesia, Local

Interventions

DRUG

Sodium Chloride 0.9% Inj

10 mL subcutaneous injection into one randomized anterior thigh of subject

DRUG

Bacteriostatic Sodium Chloride 0.9 % INJECTION VIAL (ML)

10 mL subcutaneous injection into the contralateral anterior thigh of subject

Sponsors & Collaborators

  • Jeffrey Alan Klein, MD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2022-01-31
Completion
2022-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05109000 on ClinicalTrials.gov