Alameda Health System, Highland Hospital
Oakland, California, 94602, United States
NCT Number: NCT02912195
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Oakland, California, 94602, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes
Other names: lignocaine, Xylocaine
Emergency department provider chooses appropriate dose of intravenous morphine
Other names: duramorph
Time frame: At 60 minutes
Pain score is rated on the Numeric Rating Scale from 0-10. 0 represents no pain and 10 represents the worst possible pain.
Time frame: At 10 minutes
Pain score recorded on the numeric rating scale 0-10.
Time frame: At 20 minutes
Pain score recorded on the numeric rating scale 0-10. 0 represents no pain and 10 represents the worst pain.
Time frame: At 30 minutes
Pain score recorded on the numeric rating scale 0-10.
Time frame: At 40 minutes
Pain score recorded on the numeric rating scale 0-10.
Time frame: At 50 minutes
Pain score recorded on the numeric rating scale 0-10.
Time frame: At 10 minutes
Pain NRS at 0 minutes minus pain NRS at 10 minutes
Time frame: at 20 minutes
Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 20 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.
Time frame: at 30 minutes
Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 30 minutes NRS is a scale ranging from 0, no pain, to 10 worst pain.
Time frame: At 40 minutes
Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 40 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.
Time frame: At 50 minutes
Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 50 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.
Time frame: At 60 minutes
Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 60 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.
Time frame: At 20 and 40 minutes
The percentage of patients requiring rescue IV morphine at 20 and 40 minutes
Time frame: 60 minutes
The proportion of patients saying, "Yes" to "Would you have this pain medication again for similar pain?"
Time frame: 0-60 minutes
Participants will be observed for the following adverse events and side effects: seizure, bradyarrhythmias, hyper or hypotension, perioral numbness, tinnitus, metallic taste, other, hypotension, hypoxia, nausea, vomiting, itching, or other side effects. Participants have the opportunity to report other side effects during the study
Alameda Health System
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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