NCT02912195

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

April 6, 2020

Completed
Last Updated

April 6, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

September 20, 2016

Results QC Date

June 26, 2018

Last Update Submit

March 24, 2020

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (14)

  • Pain Score (NRS 0-10)

    At 10 minutes

  • Pain Score (NRS 0-10)

    At 20 minutes

  • Pain Score (NRS 0-10)

    At 30 minutes

  • Pain Score (NRS 0-10)

    At 40 minutes

  • Pain Score (NRS 0-10)

    At 50 minutes

  • +9 more secondary outcomes

Study Arms (2)

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.

Drug: Intravenous lidocaine

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.

Drug: Intravenous morphine

Interventions

Intravenous lidocaineDRUG

Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes

Also known as: lignocaine, Xylocaine
Intravenous lidocaine
Intravenous morphineDRUG

Emergency department provider chooses appropriate dose of intravenous morphine

Also known as: duramorph
Morphine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has severe pain (NRS ≥7)
  • Subject has anticipated ED stay of ≥1 hour

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alameda Health System, Highland Hospital

Oakland, California, 94602, United States

Location

MeSH Terms

Conditions

Pain

Interventions

LidocaineMorphine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Limitations and Caveats

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

Results Point of Contact

Title
Andrew Herring
Organization
Alameda Health System
aherring@alamedahealthsystem.org
510 437-8356

Study Officials

  • Andrew Herring, MD

    Alameda Health System, Highland Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 20, 2016

First Posted

September 23, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 6, 2020

Results First Posted

April 6, 2020

Record last verified: 2020-03

Locations

US(1)