IV Insertion Pain
Conditions
Keywords
local anesthesia, intravenous catheter
Brief summary
The purpose of this study is to compare how well different anesthetic, or numbing, solutions injected under the skin work in reducing the discomfort associated with placing a catheter in a vein. Two different medications, lidocaine and normal saline with benzyl alcohol, have been found to be effective in reducing discomfort when injected under the skin just prior to inserting the catheter. This study compares these two solutions, and will compare the discomfort that occurs both with and without using these solutions.
Interventions
DRUG1% lidocaine
DRUGbacteriostatic normal saline (BNS)
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients (aged 18 or older) * admitted to a general medical or surgical unit at Durham Regional Hospital (DRH) * have a physician's order for an IV * are able to speak, read and understand English * referred to the Vascular Access Specialty Team (VAST) at DRH for IV catheterization
Exclusion criteria
* admission to the emergency room, pre-op unit, an outpatient unit, a psychiatric unit, an intensive care unit, a pre- or postnatal care unit, or labor and delivery units; * history of a psychological disorder, as determined from the patient's chart; * history of peripheral neuropathy, as determined by patient's chart; * history of IV drug abuse, as determined from the patient's chart; * decreased sensation in the arm or hands, as reported in the chart or by the patient; * patient disorientation or confusion (i.e., unable to state person, place, time or unable to comprehend instructions for completing Visual Analog Scale); * a known allergy to lidocaine or benzyl alcohol as determined from the patient's chart; * veins that cannot be palpated and are difficult to visualize by VAST nurses; * pregnancy; * an order for the emergency insertion of an IV by the patient's doctor or assigned nurse; * an IV insertion that requires the use of a catheter gauged 18 or larger * severe vision impairment, as determined by the patient's inability to read the Visual Analogue Scale
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Patients' Perceptions of Pain Between Treatment Methods | at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute | The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. The visual analog pain score will be completed at the following time points: pre injection, during injection, and during catheter insertion. |
Participant flow
Recruitment details
99 subjects consented in the study. 1 subject withdrawn from study by PI, therefore 98 subjects completed study.
Participants by arm
| Arm | Count |
|---|---|
| no Local Anesthetic usual care practice of no local anesthetic administration | 33 |
| Lidocaine 1% lidocaine intradermal injection
1% lidocaine | 33 |
| Bacteriostatic Normal Saline (BNS) bacteriostatic normal saline (BNS) injection
bacteriostatic normal saline (BNS) | 32 |
| Total | 98 |
Baseline characteristics
| Characteristic | Lidocaine | Bacteriostatic Normal Saline (BNS) | no Local Anesthetic | Total |
|---|---|---|---|---|
| Age, Customized 18 and older | 33 participants | 32 participants | 33 participants | 98 participants |
| Race/Ethnicity, Customized African American | 7 participants | 15 participants | 8 participants | 30 participants |
| Race/Ethnicity, Customized Other | 5 participants | 2 participants | 2 participants | 9 participants |
| Race/Ethnicity, Customized White | 21 participants | 15 participants | 23 participants | 59 participants |
| Region of Enrollment United States | 33 participants | 32 participants | 33 participants | 98 participants |
| Sex: Female, Male Female | 23 Participants | 16 Participants | 16 Participants | 55 Participants |
| Sex: Female, Male Male | 10 Participants | 16 Participants | 17 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 33 | 0 / 32 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 | 0 / 32 |
Outcome results
Primary
Differences in Patients' Perceptions of Pain Between Treatment Methods
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. The visual analog pain score will be completed at the following time points: pre injection, during injection, and during catheter insertion.
Time frame: at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| no Local Anesthetic | Differences in Patients' Perceptions of Pain Between Treatment Methods | Pain during catheter insertion | 1.909 units on a scale | Standard Deviation 2.127 |
| no Local Anesthetic | Differences in Patients' Perceptions of Pain Between Treatment Methods | Pain pre injection | 0.015 units on a scale | Standard Deviation 0.87 |
| no Local Anesthetic | Differences in Patients' Perceptions of Pain Between Treatment Methods | Pain during study drug injection | NA units on a scale | — |
| Lidocaine | Differences in Patients' Perceptions of Pain Between Treatment Methods | Pain during catheter insertion | 0.197 units on a scale | Standard Deviation 0.499 |
| Lidocaine | Differences in Patients' Perceptions of Pain Between Treatment Methods | Pain pre injection | 0 units on a scale | Standard Deviation 0 |
| Lidocaine | Differences in Patients' Perceptions of Pain Between Treatment Methods | Pain during study drug injection | 0.727 units on a scale | Standard Deviation 1.039 |
| Bacteriostatic Normal Saline (BNS) | Differences in Patients' Perceptions of Pain Between Treatment Methods | Pain pre injection | 0 units on a scale | Standard Deviation 0 |
| Bacteriostatic Normal Saline (BNS) | Differences in Patients' Perceptions of Pain Between Treatment Methods | Pain during study drug injection | 0.781 units on a scale | Standard Deviation 1.263 |
| Bacteriostatic Normal Saline (BNS) | Differences in Patients' Perceptions of Pain Between Treatment Methods | Pain during catheter insertion | 0.609 units on a scale | Standard Deviation 1.674 |