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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous lidocaine | Experimental | Participants 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 a 100 mL normal saline minibag. At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic. |
|
| Morphine | Active Comparator | ED provider will choose an appropriate dose of intravenous morphine for the patient. At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous lidocaine | Drug | Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score (NRS 0-10) | Pain score is rated on the Numeric Rating Scale from 0-10. 0 represents no pain and 10 represents the worst possible pain. | At 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score (NRS 0-10) | Pain score recorded on the numeric rating scale 0-10. | At 10 minutes |
| Pain Score (NRS 0-10) | Pain score recorded on the numeric rating scale 0-10. 0 represents no pain and 10 represents the worst pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Herring, MD | Alameda Health System, Highland Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alameda Health System, Highland Hospital | Oakland | California | 94602 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Lidocaine | Participants 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 a 100 mL normal saline minibag. At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic. Intravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes |
| FG001 | Morphine | ED provider will choose an appropriate dose of intravenous morphine for the patient. At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic. Intravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Lidocaine | Participants 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 a 100 mL normal saline minibag. At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic. Intravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score (NRS 0-10) | Pain score is rated on the Numeric Rating Scale from 0-10. 0 represents no pain and 10 represents the worst possible pain. | Posted | Mean | 95% Confidence Interval | units on a scale | At 60 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Lidocaine | Participants 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 a 100 mL normal saline minibag. At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic. Intravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
This study was limited by a small sample size and lack of blinding.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Herring | Alameda Health System | 510 437-8356 | aherring@alamedahealthsystem.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Intravenous morphine | Drug | Emergency department provider chooses appropriate dose of intravenous morphine |
|
|
| At 20 minutes |
| Pain Score (NRS 0-10) | Pain score recorded on the numeric rating scale 0-10. | At 30 minutes |
| Pain Score (NRS 0-10) | Pain score recorded on the numeric rating scale 0-10. | At 40 minutes |
| Pain Score (NRS 0-10) | Pain score recorded on the numeric rating scale 0-10. | At 50 minutes |
| Pain Relief at 10 Minutes Compared to Baseline. | Pain NRS at 0 minutes minus pain NRS at 10 minutes | At 10 minutes |
| Pain Relief at 20 Minutes Compared to Baseline. | 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. | at 20 minutes |
| Pain Relief at 30 Minutes Compared to Baseline. | 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. | at 30 minutes |
| Pain Relief at 40 Minutes Compared to Baseline. | 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. | At 40 minutes |
| Pain Relief at 50 Minutes Compared to Baseline. | 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. | At 50 minutes |
| Pain Relief at 60 Minutes Compared to Baseline. | 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. | At 60 minutes |
| Number of Participants Requiring Rescue Medications | The percentage of patients requiring rescue IV morphine at 20 and 40 minutes | At 20 and 40 minutes |
| Patient Satisfaction | The proportion of patients saying, "Yes" to "Would you have this pain medication again for similar pain?" | 60 minutes |
| Number of Participants Reporting Adverse Events | 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 | 0-60 minutes |
| BG001 | Morphine | ED provider will choose an appropriate dose of intravenous morphine for the patient. At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic. Intravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
ED provider will choose an appropriate dose of intravenous morphine for the patient. At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic. Intravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine |
|
|
| Secondary | Pain Score (NRS 0-10) | Pain score recorded on the numeric rating scale 0-10. | Posted | Mean | 95% Confidence Interval | units on a scale | At 10 minutes |
|
|
|
| Secondary | Pain Score (NRS 0-10) | Pain score recorded on the numeric rating scale 0-10. 0 represents no pain and 10 represents the worst pain. | Posted | Mean | 95% Confidence Interval | units on a scale | At 20 minutes |
|
|
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| Secondary | Pain Score (NRS 0-10) | Pain score recorded on the numeric rating scale 0-10. | Posted | Mean | 95% Confidence Interval | units on a scale | At 30 minutes |
|
|
|
| Secondary | Pain Score (NRS 0-10) | Pain score recorded on the numeric rating scale 0-10. | Posted | Mean | 95% Confidence Interval | units on a scale | At 40 minutes |
|
|
|
| Secondary | Pain Score (NRS 0-10) | Pain score recorded on the numeric rating scale 0-10. | Posted | Mean | 95% Confidence Interval | units on a scale | At 50 minutes |
|
|
|
| Secondary | Pain Relief at 10 Minutes Compared to Baseline. | Pain NRS at 0 minutes minus pain NRS at 10 minutes | Posted | Mean | 95% Confidence Interval | units on a scale | At 10 minutes |
|
|
|
| Secondary | Pain Relief at 20 Minutes Compared to Baseline. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | at 20 minutes |
|
|
|
| Secondary | Pain Relief at 30 Minutes Compared to Baseline. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | at 30 minutes |
|
|
|
| Secondary | Pain Relief at 40 Minutes Compared to Baseline. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | At 40 minutes |
|
|
|
| Secondary | Pain Relief at 50 Minutes Compared to Baseline. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | At 50 minutes |
|
|
|
| Secondary | Pain Relief at 60 Minutes Compared to Baseline. | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | At 60 minutes |
|
|
|
| Secondary | Number of Participants Requiring Rescue Medications | The percentage of patients requiring rescue IV morphine at 20 and 40 minutes | Posted | Count of Participants | Participants | At 20 and 40 minutes |
|
|
|
| Secondary | Patient Satisfaction | The proportion of patients saying, "Yes" to "Would you have this pain medication again for similar pain?" | 1 patient in the intravenous lidocaine arm did not answer the question. | Posted | Count of Participants | Participants | 60 minutes |
|
|
|
| Secondary | Number of Participants Reporting Adverse Events | 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 | Posted | Count of Participants | Participants | 0-60 minutes |
|
|
|
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | Morphine | ED provider will choose an appropriate dose of intravenous morphine for the patient. At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic. Intravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine | 0 | 16 | 6 | 16 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Perioral numbness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| bradycardia | Cardiac disorders | Systematic Assessment |
|
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| Aniline Compounds |
| D000588 | Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |