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NCT03571737

Efficacy of Lidocaine Patch in Acute Musculoskeletal Pain in the Emergency Department

Completed Phase 3 Results posted Last updated 25 March 2024
What this trial tests

Phase 3 trial testing Ibuprofen in Acute Musculoskeletal Disease in 23 participants. Completed in 30 January 2021.

Timeline
23 June 2018
Primary endpoint
30 December 2020
30 January 2021

Quick facts

Lead sponsorEast Carolina University
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment23
Start date23 June 2018
Primary completion30 December 2020
Estimated completion30 January 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

East Carolina University

Who can join

18 and older, any sex, with Acute Musculoskeletal Disease or Sprains. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Numerical Pain Rating Scale Primary · 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.

GroupValue95% CI
Ibuprofen- Control2.90.85 – 5.0
Ibuprofen & Lidocaine Patch 4%- Experimental2.1.30 – 3.3
Number of Participants With a Return Visit for Same Chief Complaint Secondary · 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

GroupValue95% CI
Ibuprofen- Control11
Ibuprofen & Lidocaine Patch 4%- Experimental10

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Ibuprofen

Trials testing the same drug.

Other East Carolina University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03571737.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing