Burn
Conditions
Brief summary
Patients will be randomized prospectively to one of two groups. One group will receive 5 mg/kg of 1% lidocaine, and the other will receive .9 normal saline, instilled into their VAC sponge ½ hour prior to VAC dressing change. All patients will complete a pain assessment tool prior to receiving the instilled lidocaine/placebo, immediately after the procedure and 1 hour after the procedure. Pain scores will then be compared between the lidocaine and placebo groups. Risks: Lidocaine toxicity is a potential risk, but 5 mg/kg of 1 % Lidocaine is below toxicity thresholds in an adult.
Detailed description
• All Burn service patients (inpatients and outpatients in burn clinic) who are receiving VAC therapy will be screened for study inclusion criteria. Those with allergies to lidocaine will be excluded. Participants will be enrolled until a sample size of 80 wound VAC changes is achieved. Up to 4 VAC dressing changes can be included in this study per participant. Subjects will be randomized prospectively for each dressing change. Utilizing a randomized bracketed approach, patients will be assigned to one of two groups: Lidocaine group or Placebo group. The Pharmacy Research Center (PRC) will assign patient a study Identification (ID) number and record it along with their medical record number on the Master Study ID List. They will then randomize the participants by drawing randomly shuffled green vs white index cards. (40 white card = 0.9 normal saline and 40 green card = 5 mg/kg of 1% Lidocaine). They will draw up the appropriate amount of medication to be used, label it with the patients Medical Record (MR) #, date, and administration instructions and deliver it to the nurse who is doing the VAC dressing change. They will keep the Master Randomization Data Collection Tool in a locked drawer in her office.
Interventions
DRUGInstilled 1% Lidocaine
5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
.9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* all burn service patients with a wound vac
Exclusion criteria
* allergy to lidocaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain During Dressing Change | During dressing change | A pain assessment tool performed immediately after the dressing change was used to rate pain experienced during the dressing change. For this tool, pain was rated on a scale from 0-10 (0=no pain and 10=worst possible pain) |
Countries
United States
Participant flow
Recruitment details
A total of 15 patients were enrolled with 41 VAC dressing changes. Patients could be enrolled into more than one arm.
Participants by arm
| Arm | Count |
|---|---|
| Instilled 1% Lidocaine 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change | 9 |
| Instilled 1% Lidocaine 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change | 14 |
| Instilled Placebo (0.9% Normal Saline) receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change | 12 |
| Instilled Placebo (0.9% Normal Saline) receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change | 18 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Instilled 1% Lidocaine | Instilled Placebo (0.9% Normal Saline) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 10 Participants | 18 Participants |
| Region of Enrollment United States | 9 participants | 12 participants | 21 participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 12 |
| other Total, other adverse events | 0 / 9 | 0 / 12 |
| serious Total, serious adverse events | 0 / 9 | 0 / 12 |
Outcome results
Primary
Pain During Dressing Change
A pain assessment tool performed immediately after the dressing change was used to rate pain experienced during the dressing change. For this tool, pain was rated on a scale from 0-10 (0=no pain and 10=worst possible pain)
Time frame: During dressing change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Instilled 1% Lidocaine | Pain During Dressing Change | 6.36 units on a scale | Standard Deviation 2.56 |
| Instilled Placebo (0.9% Normal Saline) | Pain During Dressing Change | 6.94 units on a scale | Standard Deviation 3.11 |