Pain
Conditions
Brief 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.
Interventions
Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes
Emergency department provider chooses appropriate dose of intravenous morphine
Sponsors
Alameda Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has severe pain (NRS ≥7) * Subject has anticipated ED stay of ≥1 hour
Exclusion criteria
* High acuity trauma patients * Patients deemed to critically ill by ED provider * Active psychosis * Pregnancy * History of heart block or bradycardia * Allergy to lidocaine or amide type local anesthetic * History of seizures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score (NRS 0-10) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief at 10 Minutes Compared to Baseline. | At 10 minutes | Pain NRS at 0 minutes minus pain NRS at 10 minutes |
| Pain Relief at 20 Minutes Compared to Baseline. | 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. |
| Pain Relief at 30 Minutes Compared to Baseline. | 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. |
| Pain Relief at 40 Minutes Compared to Baseline. | 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. |
| Pain Score (NRS 0-10) | At 10 minutes | Pain score recorded on the numeric rating scale 0-10. |
| Pain Relief at 60 Minutes Compared to Baseline. | 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. |
| Number of Participants Requiring Rescue Medications | At 20 and 40 minutes | The percentage of patients requiring rescue IV morphine at 20 and 40 minutes |
| Patient Satisfaction | 60 minutes | The proportion of patients saying, Yes to Would you have this pain medication again for similar pain? |
| Number of Participants Reporting Adverse Events | 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 |
| Pain Relief at 50 Minutes Compared to Baseline. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| 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 | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Intravenous Lidocaine | Morphine | Total |
|---|---|---|---|
| Age, Continuous | 50 years | 45.5 years | 46 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 17 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 16 | 6 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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.
Time frame: At 60 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Lidocaine | Pain Score (NRS 0-10) | 5.1 units on a scale |
| Morphine | Pain Score (NRS 0-10) | 4.2 units on a scale |
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
Time frame: 0-60 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Lidocaine | Number of Participants Reporting Adverse Events | 2 Participants |
| Morphine | Number of Participants Reporting Adverse Events | 6 Participants |
Secondary
Number of Participants Requiring Rescue Medications
The percentage of patients requiring rescue IV morphine at 20 and 40 minutes
Time frame: At 20 and 40 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Lidocaine | Number of Participants Requiring Rescue Medications | 5 Participants |
| Morphine | Number of Participants Requiring Rescue Medications | 4 Participants |
Secondary
Pain Relief at 10 Minutes Compared to Baseline.
Pain NRS at 0 minutes minus pain NRS at 10 minutes
Time frame: At 10 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Lidocaine | Pain Relief at 10 Minutes Compared to Baseline. | 1.1 units on a scale |
| Morphine | Pain Relief at 10 Minutes Compared to Baseline. | 2.0 units on a scale |
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.
Time frame: at 20 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Lidocaine | Pain Relief at 20 Minutes Compared to Baseline. | 1.8 units on a scale |
| Morphine | Pain Relief at 20 Minutes Compared to Baseline. | 2.8 units on a scale |
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.
Time frame: at 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Lidocaine | Pain Relief at 30 Minutes Compared to Baseline. | 2.2 units on a scale |
| Morphine | Pain Relief at 30 Minutes Compared to Baseline. | 3.4 units on a scale |
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.
Time frame: At 40 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Lidocaine | Pain Relief at 40 Minutes Compared to Baseline. | 2.9 units on a scale |
| Morphine | Pain Relief at 40 Minutes Compared to Baseline. | 4.2 units on a scale |
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.
Time frame: At 50 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Lidocaine | Pain Relief at 50 Minutes Compared to Baseline. | 3.6 units on a scale |
| Morphine | Pain Relief at 50 Minutes Compared to Baseline. | 4.4 units on a scale |
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.
Time frame: At 60 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Lidocaine | Pain Relief at 60 Minutes Compared to Baseline. | 4.1 units on a scale |
| Morphine | Pain Relief at 60 Minutes Compared to Baseline. | 4.8 units on a scale |
Secondary
Pain Score (NRS 0-10)
Pain score recorded on the numeric rating scale 0-10.
Time frame: At 10 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Lidocaine | Pain Score (NRS 0-10) | 8.1 units on a scale |
| Morphine | Pain Score (NRS 0-10) | 8.9 units on a scale |
Secondary
Pain Score (NRS 0-10)
Pain score recorded on the numeric rating scale 0-10.
Time frame: At 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Lidocaine | Pain Score (NRS 0-10) | 7.0 units on a scale |
| Morphine | Pain Score (NRS 0-10) | 5.6 units on a scale |
Secondary
Pain Score (NRS 0-10)
Pain score recorded on the numeric rating scale 0-10.
Time frame: At 40 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Lidocaine | Pain Score (NRS 0-10) | 6.3 units on a scale |
| Morphine | Pain Score (NRS 0-10) | 4.7 units on a scale |
Secondary
Pain Score (NRS 0-10)
Pain score recorded on the numeric rating scale 0-10.
Time frame: At 50 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Lidocaine | Pain Score (NRS 0-10) | 5.6 units on a scale |
| Morphine | Pain Score (NRS 0-10) | 4.6 units on a scale |
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.
Time frame: At 20 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous Lidocaine | Pain Score (NRS 0-10) | 7.4 units on a scale |
| Morphine | Pain Score (NRS 0-10) | 6.2 units on a scale |
Secondary
Patient Satisfaction
The proportion of patients saying, Yes to Would you have this pain medication again for similar pain?
Time frame: 60 minutes
Population: 1 patient in the intravenous lidocaine arm did not answer the question.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous Lidocaine | Patient Satisfaction | 13 Participants |
| Morphine | Patient Satisfaction | 14 Participants |