Trial Outcomes & Findings for Efficacy of Lidocaine Patch in Acute Musculoskeletal Pain in the Emergency Department (NCT NCT03571737)
NCT ID: NCT03571737
Last Updated: 2024-03-25
Results Overview
Change in self-reported pain intensity level. Baseline will be prior to intervention, and change will be assessed 60 minutes after intervention. Each item is scored 0-10 (0=No pain, 10= Worst pain possible). Higher number is worse outcome while lower number is better outcome.
COMPLETED
PHASE3
23 participants
60 minutes
2024-03-25
Participant Flow
Participant milestones
| Measure |
Ibuprofen- Control
Ibuprofen 800mg every 8 hours for 3 days
Ibuprofen: Ibuprofen tablet
|
Ibuprofen & Lidocaine Patch 4%- Experimental
Ibuprofen 800mg every 8 hours for 3 days and Lidocaine patch 4% 1 patch applied for 12 hours then removed for 12 hours, for 3 days
Ibuprofen: Ibuprofen tablet
Lidocaine Patch 4%: Lidocaine patch
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Lidocaine Patch in Acute Musculoskeletal Pain in the Emergency Department
Baseline characteristics by cohort
| Measure |
Ibuprofen
n=13 Participants
Ibuprofen 800mg every 8 hours for 3 days
Ibuprofen: Ibuprofen tablet
|
Ibuprofen & Lidocaine Patch 4%
n=10 Participants
Ibuprofen 800mg every 8 hours for 3 days and Lidocaine patch 4% 1 patch applied for 12 hours then removed for 12 hours, for 3 days
Ibuprofen: Ibuprofen tablet
Lidocaine Patch 4%: Lidocaine patch
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.2 years
STANDARD_DEVIATION 17.3 • n=99 Participants
|
36.8 years
STANDARD_DEVIATION 13.2 • n=107 Participants
|
35.8 years
STANDARD_DEVIATION 15.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
10 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Initial Pain Score
|
6.8 units on a scale
STANDARD_DEVIATION 2.0 • n=99 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 2.5 • n=107 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 2.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: 60 minutesChange in self-reported pain intensity level. Baseline will be prior to intervention, and change will be assessed 60 minutes after intervention. Each item is scored 0-10 (0=No pain, 10= Worst pain possible). Higher number is worse outcome while lower number is better outcome.
Outcome measures
| Measure |
Ibuprofen- Control
n=13 Participants
Ibuprofen 800mg every 8 hours for 3 days
Ibuprofen: Ibuprofen tablet
|
Ibuprofen & Lidocaine Patch 4%- Experimental
n=10 Participants
Ibuprofen 800mg every 8 hours for 3 days and Lidocaine patch 4% 1 patch applied for 12 hours then removed for 12 hours, for 3 days
Ibuprofen: Ibuprofen tablet
Lidocaine Patch 4%: Lidocaine patch
|
|---|---|---|
|
Change in Numerical Pain Rating Scale
|
2.9 score on a scale
Interval 0.85 to 5.0
|
2.1 score on a scale
Interval 0.3 to 3.3
|
SECONDARY outcome
Timeframe: 1 weekQuestionnaire (Yes or No) of whether a return visit to either the emergency department or primary care offices occurred within 1 week for same chief complaint from the initial visit
Outcome measures
| Measure |
Ibuprofen- Control
n=13 Participants
Ibuprofen 800mg every 8 hours for 3 days
Ibuprofen: Ibuprofen tablet
|
Ibuprofen & Lidocaine Patch 4%- Experimental
n=10 Participants
Ibuprofen 800mg every 8 hours for 3 days and Lidocaine patch 4% 1 patch applied for 12 hours then removed for 12 hours, for 3 days
Ibuprofen: Ibuprofen tablet
Lidocaine Patch 4%: Lidocaine patch
|
|---|---|---|
|
Number of Participants With a Return Visit for Same Chief Complaint
|
11 Participants
|
10 Participants
|
Adverse Events
Ibuprofen- Control
Ibuprofen & Lidocaine Patch 4%- Experimental
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jennifer Stahl
Brody School of Medicine @ East Carolina University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place