PainPhase 4NCT02912195
Intravenous Lidocaine Versus Morphine for Severe Pain in the ED
A Phase 4 study testing Intravenous lidocaine and Intravenous morphine in people with Pain, run by Alameda Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Intravenous lidocaine and Intravenous morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Sep 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has severe pain (NRS ≥7)
- Subject has anticipated ED stay of ≥1 hour
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Alameda Health System, Highland Hospital
Oakland, California, 94602
About this study
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
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Intravenous lidocaine, Intravenous morphine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous lidocaineDrug
Also called lignocaine, Xylocaine
Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes
Intravenous morphineDrug
Also called duramorph
Emergency department provider chooses appropriate dose of intravenous morphine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Intravenous morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 60 minutes
Secondary outcomes (14)
Pain Score (NRS 0-10)
Pain score recorded on the numeric rating scale 0-10.
Measured: At 10 minutes
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.
Measured: At 20 minutes
Pain Score (NRS 0-10)
Pain score recorded on the numeric rating scale 0-10.
Measured: At 30 minutes
Pain Score (NRS 0-10)
Pain score recorded on the numeric rating scale 0-10.
Measured: At 40 minutes
Pain Score (NRS 0-10)
Pain score recorded on the numeric rating scale 0-10.
Measured: At 50 minutes
Pain Relief at 10 Minutes Compared to Baseline.
Pain NRS at 0 minutes minus pain NRS at 10 minutes
Measured: At 10 minutes
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.
Measured: at 20 minutes
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.
Measured: at 30 minutes
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.
Measured: At 40 minutes
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.
Measured: At 50 minutes
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.
Measured: At 60 minutes
Number of Participants Requiring Rescue Medications
The percentage of patients requiring rescue IV morphine at 20 and 40 minutes
Measured: At 20 and 40 minutes
Patient Satisfaction
The proportion of patients saying, "Yes" to "Would you have this pain medication again for similar pain?"
Measured: 60 minutes
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
Measured: 0-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alameda Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eben Clattenburg, Alameda Health System
- Investigators
- Andrew Herring, MD, Principal investigator, Alameda Health System, Highland Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912195
- Sponsor's protocol ID
- 00001
- Status last verified
- Mar 2020
- First submitted
- 20 Sep 2016
- Last updated
- 6 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02912195
- Acronym / sponsor ID
- 00001
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Alameda Health SystemUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Posted 6 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous lidocaine | Experimental | Drug: Intravenous lidocaineParticipants 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. |
| Morphine | Active comparator | Drug: Intravenous morphineED 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has severe pain (NRS ≥7)
- Subject has anticipated ED stay of ≥1 hour
Key exclusion criteria (7 listed)
- High acuity trauma patients
- Patients deemed to critically ill by ED provider
- Active psychosis
- Pregnancy
- History of heart block or bradycardia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous lidocaineAlso: lignocaine, XylocaineIntravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes | Drug | Intravenous lidocaine |
| Intravenous morphineAlso: duramorphEmergency department provider chooses appropriate dose of intravenous morphine | Drug | Morphine |
Primary outcome
Pain Score (NRS 0-10)
Time frame: 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.
14 secondary outcomes
Pain Score (NRS 0-10)
Time frame: At 10 minutes
Pain Score (NRS 0-10)
Time frame: At 20 minutes
Pain Score (NRS 0-10)
Time frame: At 30 minutes
Pain Score (NRS 0-10)
Time frame: At 40 minutes
Pain Score (NRS 0-10)
Time frame: At 50 minutes
Pain Relief at 10 Minutes Compared to Baseline.
Time frame: At 10 minutes
Pain Relief at 20 Minutes Compared to Baseline.
Time frame: at 20 minutes
Pain Relief at 30 Minutes Compared to Baseline.
Time frame: at 30 minutes
Pain Relief at 40 Minutes Compared to Baseline.
Time frame: At 40 minutes
Pain Relief at 50 Minutes Compared to Baseline.
Time frame: At 50 minutes
Pain Relief at 60 Minutes Compared to Baseline.
Time frame: At 60 minutes
Number of Participants Requiring Rescue Medications
Time frame: At 20 and 40 minutes
Patient Satisfaction
Time frame: 60 minutes
Number of Participants Reporting Adverse Events
Time frame: 0-60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Herring, MD principal investigator
Alameda Health System, Highland Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous lidocaine and Intravenous morphine in people with Pain, run by Alameda Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (NRS 0-10) (time frame: At 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.