Intravenous Lidocaine Versus Morphine for Severe Pain in the ED

• Sponsor: Alameda Health System (Other)
• Overall Status: Completed
• CT.gov ID: NCT02912195
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Intravenous lidocaine; Drug: Intravenous morphine	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Intravenous lidocaine; Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes; Other Names: lignocaine Xylocaine
Active Comparator: 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.	Drug: Intravenous morphine; Emergency department provider chooses appropriate dose of intravenous morphine; Other Names: duramorph

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Pain Score (NRS 0-10) [At 10 minutes]

   Pain score recorded on the numeric rating scale 0-10.

2. Pain Score (NRS 0-10) [At 20 minutes]

   Pain score recorded on the numeric rating scale 0-10. 0 represents no pain and 10 represents the worst pain.

3. Pain Score (NRS 0-10) [At 30 minutes]

   Pain score recorded on the numeric rating scale 0-10.

4. Pain Score (NRS 0-10) [At 40 minutes]

   Pain score recorded on the numeric rating scale 0-10.

5. Pain Score (NRS 0-10) [At 50 minutes]

   Pain score recorded on the numeric rating scale 0-10.

6. Pain Relief at 10 Minutes Compared to Baseline. [At 10 minutes]

   Pain NRS at 0 minutes minus pain NRS at 10 minutes

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. Number of Participants Requiring Rescue Medications [At 20 and 40 minutes]

    The percentage of patients requiring rescue IV morphine at 20 and 40 minutes

13. Patient Satisfaction [60 minutes]

    The proportion of patients saying, "Yes" to "Would you have this pain medication again for similar pain?"

14. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alameda Health System, Highland Hospital	Oakland	California	United States	94602

Sponsors and Collaborators

• Alameda Health System

Investigators

• Principal Investigator: Andrew Herring, MD, Alameda Health System, Highland Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eben Clattenburg, Principle Investigator, Alameda Health System
• ClinicalTrials.gov Identifier: NCT02912195
• Other Study ID Numbers: 00001
• First Posted: Sep 23, 2016
• Last Update Posted: Apr 6, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Lidocaine; Morphine

Study Results

Participant Flow

Arm/Group Title	Intravenous Lidocaine	Morphine
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	16	16
COMPLETED	16	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intravenous Lidocaine	Morphine	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	16	16	32
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	50	45.5	46
Sex: Female, Male (Count of Participants)
Female	8 50%	9 56.3%	17 53.1%
Male	8 50%	7 43.8%	15 46.9%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Pain Score (NRS 0-10)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Lidocaine	Morphine
Arm/Group Description	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	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
Measure Participants	16	16
Mean (95% Confidence Interval) [units on a scale]	5.1	4.2

2. Secondary Outcome

Title	Pain Score (NRS 0-10)
Description	Pain score recorded on the numeric rating scale 0-10.
Time Frame	At 10 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Lidocaine	Morphine
Arm/Group Description	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	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
Measure Participants	16	16
Mean (95% Confidence Interval) [units on a scale]	8.1	8.9

3. Secondary Outcome

Title	Pain Score (NRS 0-10)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Lidocaine	Morphine
Arm/Group Description	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	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
Measure Participants	16	16
Mean (95% Confidence Interval) [units on a scale]	7.4	6.2

4. Secondary Outcome

Title	Pain Score (NRS 0-10)
Description	Pain score recorded on the numeric rating scale 0-10.
Time Frame	At 30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Lidocaine	Morphine
Arm/Group Description	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	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
Measure Participants	16	16
Mean (95% Confidence Interval) [units on a scale]	7.0	5.6

5. Secondary Outcome

Title	Pain Score (NRS 0-10)
Description	Pain score recorded on the numeric rating scale 0-10.
Time Frame	At 40 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Lidocaine	Morphine
Arm/Group Description	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	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
Measure Participants	16	16
Mean (95% Confidence Interval) [units on a scale]	6.3	4.7

6. Secondary Outcome

Title	Pain Score (NRS 0-10)
Description	Pain score recorded on the numeric rating scale 0-10.
Time Frame	At 50 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Lidocaine	Morphine
Arm/Group Description	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	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
Measure Participants	16	16
Mean (95% Confidence Interval) [units on a scale]	5.6	4.6

7. Secondary Outcome

Title	Pain Relief at 10 Minutes Compared to Baseline.
Description	Pain NRS at 0 minutes minus pain NRS at 10 minutes
Time Frame	At 10 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Lidocaine	Morphine
Arm/Group Description	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	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
Measure Participants	16	16
Mean (95% Confidence Interval) [units on a scale]	1.1	2.0

8. Secondary Outcome

Title	Pain Relief at 20 Minutes Compared to Baseline.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Lidocaine	Morphine
Arm/Group Description	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	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
Measure Participants	16	16
Mean (95% Confidence Interval) [units on a scale]	1.8	2.8

9. Secondary Outcome

Title	Pain Relief at 30 Minutes Compared to Baseline.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Lidocaine	Morphine
Arm/Group Description	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	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
Measure Participants	16	16
Mean (95% Confidence Interval) [units on a scale]	2.2	3.4

10. Secondary Outcome

Title	Pain Relief at 40 Minutes Compared to Baseline.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Lidocaine	Morphine
Arm/Group Description	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	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
Measure Participants	16	16
Mean (95% Confidence Interval) [units on a scale]	2.9	4.2

11. Secondary Outcome

Title	Pain Relief at 50 Minutes Compared to Baseline.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Lidocaine	Morphine
Arm/Group Description	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	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
Measure Participants	16	16
Mean (95% Confidence Interval) [units on a scale]	3.6	4.4

12. Secondary Outcome

Title	Pain Relief at 60 Minutes Compared to Baseline.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Lidocaine	Morphine
Arm/Group Description	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	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
Measure Participants	16	16
Mean (95% Confidence Interval) [units on a scale]	4.1	4.8

13. Secondary Outcome

Title	Number of Participants Requiring Rescue Medications
Description	The percentage of patients requiring rescue IV morphine at 20 and 40 minutes
Time Frame	At 20 and 40 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Lidocaine	Morphine
Arm/Group Description	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	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
Measure Participants	16	16
Count of Participants [Participants]	5 31.3%	4 25%

14. Secondary Outcome

Title	Patient Satisfaction
Description	The proportion of patients saying, "Yes" to "Would you have this pain medication again for similar pain?"
Time Frame	60 minutes

Outcome Measure Data

Analysis Population Description

1 patient in the intravenous lidocaine arm did not answer the question.

Arm/Group Title	Intravenous Lidocaine	Morphine
Arm/Group Description	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	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
Measure Participants	15	16
Count of Participants [Participants]	13 81.3%	14 87.5%

15. Secondary Outcome

Title	Number of Participants Reporting Adverse Events
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Lidocaine	Morphine
Arm/Group Description	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	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
Measure Participants	16	16
Count of Participants [Participants]	2 12.5%	6 37.5%

Adverse Events

Arm/Group Title	Intravenous Lidocaine		Morphine
Arm/Group Description	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		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
All Cause Mortality
	Intravenous Lidocaine		Morphine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intravenous Lidocaine		Morphine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Intravenous Lidocaine		Morphine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/16 (12.5%)		6/16 (37.5%)
Cardiac disorders
bradycardia	0/16 (0%)	0	1/16 (6.3%)	1
Gastrointestinal disorders
Nausea	1/16 (6.3%)	1	4/16 (25%)	4
Skin and subcutaneous tissue disorders
Pruritus	1/16 (6.3%)	1	1/16 (6.3%)	1
Perioral numbness	1/16 (6.3%)	1	0/16 (0%)	0

Limitations/Caveats

This study was limited by a small sample size and lack of blinding.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.