Clinical Trials Directory

Trials / Completed

CompletedNCT02912195

Intravenous Lidocaine Versus Morphine for Severe Pain in the ED

Intravenous Lidocaine Versus Provider Chosen Dose of Morphine for the Treatment of Severe Pain in the Emergency Department: An Open-label Randomized Controlled Pilot Study

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Alameda Health System · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Objective: Evaluate the analgesic efficacy of intravenous (IV) lidocaine versus provider chosen dose of IV morphine for the treatment of severe pain in the emergency department. Study design: Open-label, randomized controlled pilot study.

Detailed description

Objective: The purpose of this pilot study is to determine the analgesic efficacy of intravenous lidocaine versus morphine for the treatment of severe pain in the emergency department (ED). Study design: Open-label, randomized, controlled pilot trial. Participants: Investigators and research assistants will recruit patients ≥18 years old with severe pain (NRS ≥7) and an anticipated stay in the emergency department ≥1 hour. A sample size calculation was performed and 32 patients will be enrolled. Intervention: After a trained research assistant obtains written informed consent, eligible participants will be randomized to the intravenous lidocaine or morphine arms of the study. In the intravenous lidocaine arm, patients will receive IV lidocaine (75 mg if \<50kg, 100 mg if 50 - 100 kg, and 150 mg if \>100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if \<50kg, 100 mg if 50 - 100 kg, and 150 mg if \>100 kg). In the morphine arm, the ED provider will choose an appropriate dose of morphine for the patient. At 20 and 40 minutes, the participants will be asked "Would you like additional pain medication?". Participants responding in the affirmative will receive morphine 4 mg IV. Data collection: The trained research assistant will collect data on the patients' pain scores, side effects, and rescue morphine. Statistical analysis: Investigators will perform descriptive statistics and compare pain scores and pain relief at each time point with unpaired t-tests.

Conditions

Interventions

TypeNameDescription
DRUGIntravenous lidocaineIntravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes
DRUGIntravenous morphineEmergency department provider chooses appropriate dose of intravenous morphine

Timeline

Start date
2016-03-01
Primary completion
2016-09-01
Completion
2016-09-01
First posted
2016-09-23
Last updated
2020-04-06
Results posted
2020-04-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02912195. Inclusion in this directory is not an endorsement.