Injection Site IrritationPhase 4NCT05109000
Comparison of Subcutaneous Injection of Normal Saline and Bacteriostatic Saline
A Phase 4 study testing Sodium Chloride 0.9% Inj and Bacteriostatic Sodium Chloride 0.9 % INJECTION VIAL (ML) in people with Injection Site Irritation and Injection Site Bruising, run by Jeffrey Alan Klein, MD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Injection Site Irritation, Injection Site Bruising, Injection Site Discomfort
- What is being tested?
- Sodium Chloride 0.9% Inj and Bacteriostatic Sodium Chloride 0.9 % INJECTION VIAL (ML)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2021to Jan 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
HK Dermatology
San Juan Capistrano, California, 92675
Claire M Richards, 949-390-4965, crichards7899@yahoo.com
Jeffrey A Klein, MD
About this study
Official title: Clinical Effects of the Subcutaneous Injection of 10ml of Normal Saline and Bacteriostatic Saline: A Double-Blind Randomized Clinical Trial
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.
Read the detailed description
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.
The sample size for this study is 32 subjects with a stopping point for analysis after 16 subjects. The sample size must be a multiple of four to satisfy the randomization in groups of four criteria. Investigators are analyzing the t-statistics at a level of alpha = 0.01, considering the Bonferroni correction. If after 16 subjects, statistical significance showing a difference between NS and BS has not been reached, investigators will continue with 16 more subjects.
Tenderness, soreness, and pruritis NPS will be evaluated by paired t-tests to determine if the effects of injection by NS vs. BS differ at each of the four evaluation times. Investigators will do the same for the quantitative data gathered for bruising and redness surface area. This quantitative analysis will result in t-statistics and corresponding P-values which will be evaluated with an alpha = 0.01, considering the Bonferroni correction. For the categorical data for the intensity of bruising and redness/inflammation, investigators will create the categories of none (0), mild (1), moderate (2), and intense (3) and use this data to perform t-tests for significance.
- Conditions
- Injection Site Irritation, Injection Site Bruising, Injection Site Discomfort, Benzoic Acid Adverse Reaction, Anesthesia, Local
- Being tested
- Sodium Chloride 0.9% Inj, Bacteriostatic Sodium Chloride 0.9 % INJECTION VIAL (ML)
- Keywords
- normal saline, bacteriostatic saline, subcutaneous injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Chloride 0.9% InjDrug
Also called normal saline
10 mL subcutaneous injection into one randomized anterior thigh of subject
Bacteriostatic Sodium Chloride 0.9 % INJECTION VIAL (ML)Drug
Also called bacteriostatic saline
10 mL subcutaneous injection into the contralateral anterior thigh of subject
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Experimental | 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. Receives: Drug: Sodium Chloride 0.9% Inj |
| Bacteriostatic Saline | Experimental | 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. Receives: Drug: Bacteriostatic Sodium Chloride 0.9 % INJECTION VIAL (ML) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injection Pain
Numerical Pain Score (NPS): 0-10
Measured: Time Post-Injection: 0 minutes
Erythema
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Measured: Time Post-Injection: 5 minutes
Erythema
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Measured: Time Post-Injection: 1 hour
Erythema
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Measured: Time Post-Injection: 24 hours
Erythema
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Measured: Time Post-Injection: 48 hours
Erythema
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Measured: Time Post-Injection: 7 days
Bruising
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Measured: Time Post-Injection: 5 minutes
Bruising
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Measured: Time Post-Injection: 1 hour
Bruising
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Measured: Time Post-Injection: 24 hours
Bruising
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Measured: Time Post-Injection: 48 hours
Bruising
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Measured: Time Post-Injection: 7 days
Tenderness
Numerical Pain Score (NPS): 0-10
Measured: Time Post-Injection: 5 minutes
Tenderness
Numerical Pain Score (NPS): 0-10
Measured: Time Post-Injection: 1 hour
Tenderness
Numerical Pain Score (NPS): 0-10
Measured: Time Post-Injection: 24 hours
Tenderness
Numerical Pain Score (NPS): 0-10
Measured: Time Post-Injection: 48 hours
Tenderness
Numerical Pain Score (NPS): 0-10
Measured: Time Post-Injection: 7 days
Soreness
Numerical Pain Score (NPS): 0-10
Measured: Time Post-Injection: 5 minutes
Soreness
Numerical Pain Score (NPS): 0-10
Measured: Time Post-Injection: 1 hour
Soreness
Numerical Pain Score (NPS): 0-10
Measured: Time Post-Injection: 24 hours
Soreness
Numerical Pain Score (NPS): 0-10
Measured: Time Post-Injection: 48 hours
Soreness
Numerical Pain Score (NPS): 0-10
Measured: Time Post-Injection: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection Site IrritationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Subjects will receive both treatments: one in each thigh. Random allocation of subcutaneous injections of 10 mL of normal saline into one anterior thigh and 10 mL of bacteriostatic saline into the contralateral anterior thigh. Paired t-tests to compare the clinical effects of the two solutions.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeffrey Alan Klein, MD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Jeffrey Alan Klein, MD, HK Surgical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109000
- Sponsor's protocol ID
- NS vs. BS
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of the Subcutaneous Injection of 10ml of Normal Saline and Bacteriostatic Saline: A Double-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05109000
- Acronym / sponsor ID
- NS vs. BS
- Conditions
- Injection Site Irritation, Injection Site Bruising, Injection Site Discomfort, Benzoic Acid Adverse Reaction, Anesthesia, Local
- Keywords
- normal saline, bacteriostatic saline, subcutaneous injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Jeffrey Alan Klein, MDIndustry (pharma, biotech, devices)
- Study start
- Nov 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The sample size for this study is 32 subjects with a stopping point for analysis after 16 subjects. The sample size must be a multiple of four to satisfy the randomization in groups of four criteria. Investigators are analyzing the t-statistics at a level of alpha = 0.01, considering the Bonferroni correction. If after 16 subjects, statistical significance showing a difference between NS and BS has not been reached, investigators will continue with 16 more subjects.
Tenderness, soreness, and pruritis NPS will be evaluated by paired t-tests to determine if the effects of injection by NS vs. BS differ at each of the four evaluation times. Investigators will do the same for the quantitative data gathered for bruising and redness surface area. This quantitative analysis will result in t-statistics and corresponding P-values which will be evaluated with an alpha = 0.01, considering the Bonferroni correction. For the categorical data for the intensity of bruising and redness/inflammation, investigators will create the categories of none (0), mild (1), moderate (2), and intense (3) and use this data to perform t-tests for significance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will receive both treatments: one in each thigh. Random allocation of subcutaneous injections of 10 mL of normal saline into one anterior thigh and 10 mL of bacteriostatic saline into the contralateral anterior thigh. Paired t-tests to compare the clinical effects of the two solutions.
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Experimental | Drug: Sodium Chloride 0.9% InjThis 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. |
| Bacteriostatic Saline | Experimental | Drug: Bacteriostatic Sodium Chloride 0.9 % INJECTION VIAL (ML)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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Chloride 0.9% InjAlso: normal saline10 mL subcutaneous injection into one randomized anterior thigh of subject | Drug | Normal Saline |
| Bacteriostatic Sodium Chloride 0.9 % INJECTION VIAL (ML)Also: bacteriostatic saline10 mL subcutaneous injection into the contralateral anterior thigh of subject | Drug | Bacteriostatic Saline |
Primary outcome
Injection Pain
Time frame: Time Post-Injection: 0 minutes
Numerical Pain Score (NPS): 0-10
Erythema
Time frame: Time Post-Injection: 5 minutes
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Erythema
Time frame: Time Post-Injection: 1 hour
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Erythema
Time frame: Time Post-Injection: 24 hours
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Erythema
Time frame: Time Post-Injection: 48 hours
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Erythema
Time frame: Time Post-Injection: 7 days
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Bruising
Time frame: Time Post-Injection: 5 minutes
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Bruising
Time frame: Time Post-Injection: 1 hour
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Bruising
Time frame: Time Post-Injection: 24 hours
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Bruising
Time frame: Time Post-Injection: 48 hours
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Bruising
Time frame: Time Post-Injection: 7 days
Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)
Tenderness
Time frame: Time Post-Injection: 5 minutes
Numerical Pain Score (NPS): 0-10
Tenderness
Time frame: Time Post-Injection: 1 hour
Numerical Pain Score (NPS): 0-10
Tenderness
Time frame: Time Post-Injection: 24 hours
Numerical Pain Score (NPS): 0-10
Tenderness
Time frame: Time Post-Injection: 48 hours
Numerical Pain Score (NPS): 0-10
Tenderness
Time frame: Time Post-Injection: 7 days
Numerical Pain Score (NPS): 0-10
Soreness
Time frame: Time Post-Injection: 5 minutes
Numerical Pain Score (NPS): 0-10
Soreness
Time frame: Time Post-Injection: 1 hour
Numerical Pain Score (NPS): 0-10
Soreness
Time frame: Time Post-Injection: 24 hours
Numerical Pain Score (NPS): 0-10
Soreness
Time frame: Time Post-Injection: 48 hours
Numerical Pain Score (NPS): 0-10
Soreness
Time frame: Time Post-Injection: 7 days
Numerical Pain Score (NPS): 0-10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Chloride 0.9% Inj and Bacteriostatic Sodium Chloride 0.9 % INJECTION VIAL (ML) in people with Injection Site Irritation and Injection Site Bruising, run by Jeffrey Alan Klein, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire M Richards (9493904965, crichards7899@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injection Pain (time frame: Time Post-Injection: 0 minutes). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.