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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.
• 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Instilled 1% Lidocaine | Experimental | 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change |
|
| Instilled Placebo (0.9% Normal Saline) | Placebo Comparator | receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Instilled 1% Lidocaine | Drug | 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | During dressing change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Schurr, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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A total of 15 patients were enrolled with 41 VAC dressing changes. Patients could be enrolled into more than one arm.
| ID | Title | Description |
|---|---|---|
| FG000 | Instilled 1% Lidocaine | 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change |
| FG001 | Instilled Placebo (0.9% Normal Saline) | receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Instilled 1% Lidocaine | 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change |
| BG001 | Instilled Placebo (0.9% Normal Saline) | receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | units on a scale | During dressing change | VAC dressing changes | VAC dressing changes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Instilled 1% Lidocaine | 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cindy Schmitz, RN, MS, NP | University of Wisconsin-Madison | 608-262-2664 | CSchmitz@uwhealth.org |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo (0.9% Normal Saline) | Other | .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change |
|
|
| BG002 | Total | Total of all reporting groups |
| VAC dressing changes |
|
| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Instilled Placebo (0.9% Normal Saline) | receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change | 0 | 12 | 0 | 12 | 0 | 12 |
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| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |