Acute Musculoskeletal Disease, Acute Pain, Emergencies, Injuries, Sprains, Sprains and Strains, Trauma
Conditions
Keywords
acute pain, muscle strain, muscle sprain, injury, emergency department
Brief summary
This study evaluates the addition of a lidocaine patch to ibuprofen in the treatment of acute musculoskeletal pains. Half of the participants will get only ibuprofen for their pain, while other half will receive lidocaine patch plus the ibuprofen. After addition of the pain medications, the participants will be followed for their pain scores and return visits.
Detailed description
Ibuprofen and other nonsteroidal antiinflammatory pain medications have been traditionally used for relief of mild to moderate acute musculoskeletal pains. However, if this medication did not work, a different modality for pain control would be added to the original regimen. In recent times, lidocaine patch has been introduced as a separate modality for pain control. This medication is thought to help by selectively inhibiting voltage-gated sodium channels in nociceptors involved in pain response. Given the separate modality, it would be prudent to see whether the addition of lidocaine patch to the ibuprofen would help relieve the pain more so than the antiinflammatory-only regimen.
Interventions
DRUGIbuprofen
Ibuprofen tablet
Lidocaine patch
Sponsors
East Carolina University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject's age is greater than or equal to 18 years old * Subject is able to speak English * Subject has chief complaint of musculoskeletal pain lasting less than or equal to 7 days * Subject's area of greatest pain isolated to one body part * Subject does not have prior Emergency Department visits recorded on electronic medical records for the chief complaint
Exclusion criteria
* Subject's age is less than 18 years old * Subject is pregnant or breastfeeding patients * Subject cannot speak English * Subject has multiple traumatic injuries or injury requiring consultation with the trauma service per study facility's guidelines * Subject has cellulitis or infection overlying the injuries * Subject has open wound overlying the injuries * Subject's chief complaint is caused by penetrating injury * Subject has absolute contraindications to study medications, including anaphylaxis to lidocaine or nonsteroidal antiinflammatory drugs, history of active GI bleeding or recent coronary artery bypass graft surgery precluding nonsteroidal antiinflammatory medications, severe hepatic disease (hepatitis, cirrhosis in current chart or prior history or elevation in liver function tests to clinically significant levels in past 6 months), severe kidney disease (Creatinine clearance less than 30 milliliters or history of chronic kidney disease stage 3 or worse), congestive heart failure. * Subject has medication contraindications such as concurrent use of medications listed: Alcuronium, Amphotericin B, Amprenavir, Atracurium, Cimetidine, Edrophonium, Enflurane, Fosphenytoin, Halothane, Nadolol, Oxprenolol, Pentazocine, Propafenone * Subject is on class I antiarrhythmics therapy (including lidocaine, procainamide, disopyramide etc) * Subject has injuries requiring splint/casting where patient may not be able to reach the area of greatest pain to apply and reapply the patch * Subject has prior history of chronic pain in the affected area (defined as greater than or equal to 6 weeks of pain) * Subject has received opioid medication in triage area or within 4 hours of initial treatment * Subject is unable to give pain scores due to mental status * Subject's initial numerical pain scale score of 0 (which would constitute no pain on the scale) * Subject requires opiate medication or muscle relaxants (Flexeril, Valium, Tizanidine, Robaxin etc) during the initial visit to Emergency department at the discretion of the provider. * Subjects who received less than 800 milligram oral dosage of ibuprofen in triage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Numerical Pain Rating Scale | 60 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Return Visit for Same Chief Complaint | 1 week | Questionnaire (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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ibuprofen Ibuprofen 800mg every 8 hours for 3 days
Ibuprofen: Ibuprofen tablet | 13 |
| Ibuprofen & Lidocaine Patch 4% 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 | 10 |
| Total | 23 |
Baseline characteristics
| Characteristic | Ibuprofen | Ibuprofen & Lidocaine Patch 4% | Total |
|---|---|---|---|
| Age, Continuous | 35.2 years STANDARD_DEVIATION 17.3 | 36.8 years STANDARD_DEVIATION 13.2 | 35.8 years STANDARD_DEVIATION 15.3 |
| Initial Pain Score | 6.8 units on a scale STANDARD_DEVIATION 2 | 6.8 units on a scale STANDARD_DEVIATION 2.5 | 6.8 units on a scale STANDARD_DEVIATION 2.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 5 Participants | 5 Participants | 10 Participants |
| Region of Enrollment United States | 13 participants | 10 participants | 23 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 10 |
| other Total, other adverse events | 0 / 13 | 0 / 10 |
| serious Total, serious adverse events | 0 / 13 | 0 / 10 |
Outcome results
Primary
Change in Numerical Pain Rating Scale
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.
Time frame: 60 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ibuprofen- Control | Change in Numerical Pain Rating Scale | 2.9 score on a scale |
| Ibuprofen & Lidocaine Patch 4%- Experimental | Change in Numerical Pain Rating Scale | 2.1 score on a scale |
Secondary
Number of Participants With a Return Visit for Same Chief Complaint
Questionnaire (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
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ibuprofen- Control | Number of Participants With a Return Visit for Same Chief Complaint | 11 Participants |
| Ibuprofen & Lidocaine Patch 4%- Experimental | Number of Participants With a Return Visit for Same Chief Complaint | 10 Participants |