Clinical Effects of the Subcutaneous Injection of 10ml of Normal Saline and Bacteriostatic Saline: A Double-Blind Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Erythema
研究概览
简要总结
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.
详细描述
Both normal saline and bacteriostatic saline are often used as vehicles for the injection of therapeutic drugs. However, their properties differ slightly as a result of the 0.9% benzyl alcohol component of BS. While benzyl alcohol is known to have local anesthetic properties, it also is an irritant and can cause inflammation at the injection site. In acidic conditions, benzyl alcohol is converted to benzoic acid and benzaldehyde. Objective and prospective data are needed to confirm these characteristics.
The present protocol calls for random allocation of subcutaneous injections of 10 mL of NS into one anterior thigh and 10 mL of BS into the contralateral anterior thigh. Based on the verified safety of up to 30 mL of 0.9% bacteriostatic saline, this volume of saline solution poses little to no risk.
Each thigh will receive one subcutaneous injection of either NS or BS, which will be determined by random allocation. Clinical follow-up examination will be done at 24 hours, 48 hours, and 7 days.
It is expected that by day seven, all signs of inflammation or bruising will have resolved.
Both NS and BS are FDA-approved for subcutaneous injection and are commonly utilized daily by many physicians. A study documenting the benefits and disadvantages of NS and BS has never been done to the investigators' knowledge and will be helpful for medical professionals in determining which type of solution to use in certain circumstances.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Normal Saline
This is a randomized, double-blind, single-center clinical trial comparing normal saline and bacteriostatic saline subcutaneous injection within a single subject. In this arm, the subject will receive a 10 mL subcutaneous injection of normal saline into either their left or right anterior thigh. The side will be determined by randomization protocol.
干预措施: Sodium Chloride 0.9% Inj (Drug)
Bacteriostatic Saline
This is a randomized, double-blind, single-center clinical trial comparing normal saline and bacteriostatic saline subcutaneous injection within a single subject. In this arm, the subject will receive a 10 mL subcutaneous injection of bacteriostatic saline into either their left or right anterior thigh. The side will be determined by randomization protocol.
干预措施: Bacteriostatic Sodium Chloride 0.9 % INJECTION VIAL (ML) (Drug)
结局指标
主要结局
Erythema
时间窗: Time Post-Injection: 7 days
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Injection Pain
时间窗: Time Post-Injection: 0 minutes
Numerical Pain Score (NPS): 0-10
Bruising
时间窗: Time Post-Injection: 7 days
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Tenderness
时间窗: Time Post-Injection: 7 days
Numerical Pain Score (NPS): 0-10
Soreness
时间窗: Time Post-Injection: 7 days
Numerical Pain Score (NPS): 0-10
次要结局
未报告次要终点
研究者
Jeffrey Alan Klein, MD
Founder and CEO, Physician
HK Surgical, Inc.