Trial Outcomes & Findings for Intravenous Lidocaine Versus Morphine for Severe Pain in the ED (NCT NCT02912195)

NCT ID: NCT02912195

Last Updated: 2020-04-06

Results Overview

Pain score is rated on the Numeric Rating Scale from 0-10. 0 represents no pain and 10 represents the worst possible pain.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 32 participants
• Primary outcome timeframe: At 60 minutes
• Results posted on: 2020-04-06

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	16	16
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intravenous Lidocaine n=16 Participants 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	Morphine n=16 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	Total n=32 Participants Total of all reporting groups
Age, Continuous	50 years n=16 Participants	45.5 years n=16 Participants	46 years n=32 Participants
Sex: Female, Male Female	8 Participants n=16 Participants	9 Participants n=16 Participants	17 Participants n=32 Participants
Sex: Female, Male Male	8 Participants n=16 Participants	7 Participants n=16 Participants	15 Participants n=32 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intravenous Lidocaine n=16 Participants 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	Morphine n=16 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
Pain Score (NRS 0-10)	5.1 units on a scale Interval 3.3 to 6.8	4.2 units on a scale Interval 3.0 to 5.4

SECONDARY outcome

Timeframe: At 10 minutes

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

Outcome measures

Measure	Intravenous Lidocaine n=16 Participants 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	Morphine n=16 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
Pain Score (NRS 0-10)	8.1 units on a scale Interval 7.1 to 9.0	8.9 units on a scale Interval 8.3 to 9.6

SECONDARY outcome

Timeframe: At 20 minutes

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

Outcome measures

Measure	Intravenous Lidocaine n=16 Participants 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	Morphine n=16 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
Pain Score (NRS 0-10)	7.4 units on a scale Interval 6.3 to 8.4	6.2 units on a scale Interval 4.6 to 7.8

SECONDARY outcome

Timeframe: At 30 minutes

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

Outcome measures

Measure	Intravenous Lidocaine n=16 Participants 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	Morphine n=16 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
Pain Score (NRS 0-10)	7.0 units on a scale Interval 5.9 to 8.1	5.6 units on a scale Interval 4.0 to 7.1

SECONDARY outcome

Timeframe: At 40 minutes

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

Outcome measures

Measure	Intravenous Lidocaine n=16 Participants 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	Morphine n=16 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
Pain Score (NRS 0-10)	6.3 units on a scale Interval 5.0 to 7.5	4.7 units on a scale Interval 3.2 to 6.3

SECONDARY outcome

Timeframe: At 50 minutes

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

Outcome measures

Measure	Intravenous Lidocaine n=16 Participants 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	Morphine n=16 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
Pain Score (NRS 0-10)	5.6 units on a scale Interval 4.1 to 7.1	4.6 units on a scale Interval 3.1 to 6.0

SECONDARY outcome

Timeframe: At 10 minutes

Pain NRS at 0 minutes minus pain NRS at 10 minutes

Outcome measures

Measure	Intravenous Lidocaine n=16 Participants 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	Morphine n=16 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
Pain Relief at 10 Minutes Compared to Baseline.	1.1 units on a scale Interval 0.5 to 1.8	2.0 units on a scale Interval 0.9 to 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intravenous Lidocaine n=16 Participants 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	Morphine n=16 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
Pain Relief at 20 Minutes Compared to Baseline.	1.8 units on a scale Interval 1.1 to 2.5	2.8 units on a scale Interval 1.4 to 4.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intravenous Lidocaine n=16 Participants 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	Morphine n=16 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
Pain Relief at 30 Minutes Compared to Baseline.	2.2 units on a scale Interval 1.4 to 3.0	3.4 units on a scale Interval 1.9 to 4.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intravenous Lidocaine n=16 Participants 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	Morphine n=16 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
Pain Relief at 40 Minutes Compared to Baseline.	2.9 units on a scale Interval 1.7 to 4.1	4.2 units on a scale Interval 2.9 to 5.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intravenous Lidocaine n=16 Participants 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	Morphine n=16 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
Pain Relief at 50 Minutes Compared to Baseline.	3.6 units on a scale Interval 2.2 to 5.0	4.4 units on a scale Interval 3.2 to 5.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intravenous Lidocaine n=16 Participants 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	Morphine n=16 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
Pain Relief at 60 Minutes Compared to Baseline.	4.1 units on a scale Interval 2.6 to 5.7	4.8 units on a scale Interval 3.7 to 5.8

SECONDARY outcome

Timeframe: At 20 and 40 minutes

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

Outcome measures

Measure	Intravenous Lidocaine n=16 Participants 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	Morphine n=16 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
Number of Participants Requiring Rescue Medications	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 60 minutes

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

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

Outcome measures

Measure	Intravenous Lidocaine n=15 Participants 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	Morphine n=16 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
Patient Satisfaction	13 Participants	14 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Intravenous Lidocaine n=16 Participants 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	Morphine n=16 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
Number of Participants Reporting Adverse Events	2 Participants	6 Participants

Adverse Events

Intravenous Lidocaine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Morphine

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intravenous Lidocaine n=16 participants at risk 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	Morphine n=16 participants at risk 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
Skin and subcutaneous tissue disorders Pruritus	6.2% 1/16 • Number of events 1	6.2% 1/16 • Number of events 1
Gastrointestinal disorders Nausea	6.2% 1/16 • Number of events 1	25.0% 4/16 • Number of events 4
Skin and subcutaneous tissue disorders Perioral numbness	6.2% 1/16 • Number of events 1	0.00% 0/16
Cardiac disorders bradycardia	0.00% 0/16	6.2% 1/16 • Number of events 1

Additional Information

Andrew Herring

Alameda Health System

Phone: 510 437-8356

Email: aherring@alamedahealthsystem.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place