Need for Intravenous Catheter
Conditions
Keywords
intravenous catheter, emergency department, pain
Brief summary
This study will determine whether application of a patch containing a topical anesthetic (numbing medicine) named lidocaine can reduce the pain of subsequent insertion of an intravenous catheter in Emergency Department patients.
Detailed description
Patients will be randomly assigned to an active lidocaine patch or a patch that conatins a placebo or inactive agent. Neither the patient nor the practitioner will know which patch is used since they will appear identical.
Interventions
DEVICELidocaine tetracaine
Lidocaine 70 mg/tetracaine 70 mg
DEVICEPlacebo
Placebo patch identical in appearance to Synera
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 3, * Need for non-emergent intravenous catheter
Exclusion criteria
* Unstable patients, * Allergy to lidocaine or tetracaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain on Visual Analog Scale (VAS) | 0 MINUTES | Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success of Intravenous (IV) Insertion | After first attempt of catheter insertion | Percentage of patients in whom intravenous catheter was inserted successfully |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LIDODERM Patch Lidocaine 70 mg/tetracaine 70 mg skin patch | 22 |
| Control Patch Warm patch with no active substances | 23 |
| Total | 45 |
Baseline characteristics
| Characteristic | Control Patch | LIDODERM Patch | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 23 Participants | 22 Participants | 45 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 10.8 years STANDARD_DEVIATION 4.5 | 9.3 years STANDARD_DEVIATION 4.3 | 10 years STANDARD_DEVIATION 4.3 |
| Region of Enrollment United States | 23 participants | 22 participants | 45 participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 23 |
| serious Total, serious adverse events | 0 / 22 | 0 / 23 |
Outcome results
Primary
Pain on Visual Analog Scale (VAS)
Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain).
Time frame: 0 MINUTES
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| LIDODERM Patch | Pain on Visual Analog Scale (VAS) | 18 mm |
| Control Patch | Pain on Visual Analog Scale (VAS) | 35 mm |
Secondary
Success of Intravenous (IV) Insertion
Percentage of patients in whom intravenous catheter was inserted successfully
Time frame: After first attempt of catheter insertion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LIDODERM Patch | Success of Intravenous (IV) Insertion | 18 Percentage of participants |
| Control Patch | Success of Intravenous (IV) Insertion | 17 Percentage of participants |