Trial Outcomes & Findings for Intravenous Lidocaine Randomized Comparative Effectiveness Trial (NCT NCT03300674)

NCT ID: NCT03300674

Last Updated: 2020-08-10

Results Overview

Participants were asked to describe their pain on a scale from 0 to 10 with 0= no pain and 10= the worst pain imaginable

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 154 participants
• Primary outcome timeframe: up to 90 minutes
• Results posted on: 2020-08-10

Participant Flow

Participant milestones

Measure	Intravenous Hydromorphone Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes. Hydromorphone: Hydromorphone intravenous infusion	Intravenous Lidocaine Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes Lidocaine: Lidocaine intravenous infusion
Overall Study STARTED	77	77
Overall Study COMPLETED	77	77
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 Hydromorphone n=77 Participants Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes. Hydromorphone: Hydromorphone intravenous infusion	Intravenous Lidocaine n=77 Participants Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes Lidocaine: Lidocaine intravenous infusion	Total n=154 Participants Total of all reporting groups
Age, Continuous	40 years STANDARD_DEVIATION 13 • n=77 Participants	42 years STANDARD_DEVIATION 12 • n=77 Participants	41 years STANDARD_DEVIATION 13 • n=154 Participants
Sex: Female, Male Female	44 Participants n=77 Participants	54 Participants n=77 Participants	98 Participants n=154 Participants
Sex: Female, Male Male	33 Participants n=77 Participants	23 Participants n=77 Participants	56 Participants n=154 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	77 participants n=77 Participants	77 participants n=77 Participants	154 participants n=154 Participants
Pain duration in days	2 days n=77 Participants	2 days n=77 Participants	2 days n=154 Participants

PRIMARY outcome

Timeframe: up to 90 minutes

Participants were asked to describe their pain on a scale from 0 to 10 with 0= no pain and 10= the worst pain imaginable

Outcome measures

Measure	Intravenous Hydromorphone n=77 Participants Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes. Hydromorphone: Hydromorphone intravenous infusion	Intravenous Lidocaine n=77 Participants Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes Lidocaine: Lidocaine intravenous infusion
Change in 0-10 Pain Scale Between Baseline and 90 Minutes	5.0 units on a scale Standard Deviation 2.8	3.8 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: 4 hours

no need for off-protocol parenteral pain medication during the ED visit. The following parenteral medications will be considered off protocol pain medication: any opioid, any non-steroidal anti-inflammatory drug

Outcome measures

Measure	Intravenous Hydromorphone n=77 Participants Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes. Hydromorphone: Hydromorphone intravenous infusion	Intravenous Lidocaine n=77 Participants Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes Lidocaine: Lidocaine intravenous infusion
Rescue Medication	20 Participants	39 Participants

SECONDARY outcome

Timeframe: 4 hours

Any new symptom development after administration of investigational medication

Outcome measures

Measure	Intravenous Hydromorphone n=77 Participants Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes. Hydromorphone: Hydromorphone intravenous infusion	Intravenous Lidocaine n=77 Participants Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes Lidocaine: Lidocaine intravenous infusion
Adverse Events	28 Participants	23 Participants

Adverse Events

Intravenous Hydromorphone

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Intravenous Lidocaine

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intravenous Hydromorphone n=77 participants at risk Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes. Hydromorphone: Hydromorphone intravenous infusion	Intravenous Lidocaine n=77 participants at risk Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes Lidocaine: Lidocaine intravenous infusion
Nervous system disorders dizziness	18.2% 14/77 • Number of events 14 • 3 hours	5.2% 4/77 • Number of events 4 • 3 hours
Nervous system disorders drowsiness	7.8% 6/77 • Number of events 6 • 3 hours	5.2% 4/77 • Number of events 4 • 3 hours
Nervous system disorders headache	3.9% 3/77 • Number of events 3 • 3 hours	7.8% 6/77 • Number of events 6 • 3 hours
Gastrointestinal disorders nausea	16.9% 13/77 • Number of events 13 • 3 hours	11.7% 9/77 • Number of events 9 • 3 hours

Additional Information

Benjamin W. Friedman

Montefiore

Phone: 718-920-6626

Email: befriedm@montefiore.org

Results disclosure agreements

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