Abdominal PainPhase 4NCT03300674

Intravenous Lidocaine Randomized Comparative Effectiveness Trial

A Phase 4 study testing Hydromorphone and Lidocaine in people with Abdominal Pain, run by Montefiore Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Abdominal Pain
What is being tested?: Hydromorphone and Lidocaine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 154 participants
Where: 1 siteUnited States
Study dates: 10 Jan 2018to 28 Aug 2018
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

Inclusion Criteria:Eligible patients are those who present to an ED for treatment of acute abdominal pain. Acute will be defined as pain for no more than seven days. At the time of enrollment, the ED treatment plan must include use of an intravenous opioid.

Exclusion Criteria: Patients will be excluded from participation if they have cardiac conduction system impairment (QTc duration > 0.5s, QRS duration > 0.12s, or PR interval duration > 0.2s), known renal (CKD >2) or liver disease (Childs-Pugh B or greater), are hemodynamically unstable, as determined by the attending physician, are pregnant or breastfeeding, or have a known allergy to either medication. Patients will also be excluded if they have used prescription or illicit opioids within the previous week, or if they have a chronic pain disorder, defined as use of any analgesic medication on more days than not during the month preceding the acute episode of pain. Patients weighing < 60kg or > 120kg will be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain. A Randomized Trial

This is a randomized, double-blind, emergency department based, comparative effectiveness study of two medication for acute abdominal pain: intravenous lidocaine and intravenous hydromorphone. Patients will be enrolled during an emergency department visit and followed throughout their emergency department course and then by telephone 7 days later.

Conditions: Abdominal Pain
Being tested: Hydromorphone, Lidocaine
Medical subject headings: Abdominal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HydromorphoneDrug
Hydromorphone intravenous infusion
LidocaineDrug
Lidocaine intravenous infusion

Study groups in NCT03300674
Study group	Role	What they receive
Intravenous hydromorphone	Active comparator	Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes. Receives: Drug: Hydromorphone
Intravenous lidocaine	Active comparator	Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes Receives: Drug: Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in 0-10 Pain Scale Between Baseline and 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
Measured: up to 90 minutes

Secondary outcomes (2)

Rescue Medication
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
Measured: 4 hours
Adverse Events
Any new symptom development after administration of investigational medication
Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 201828 Aug 2018

First posted3 Oct 2017
Study start10 Jan 2018
Primary completion16 Aug 2018
Study completion28 Aug 2018

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Abdominal 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03300674
Sponsor's protocol ID: 2017-8408
Status last verified: Jul 2020
First submitted: 28 Sep 2017
Last updated: 10 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Chinn E, Friedman BW, Naeem F, Irizarry E, Afrifa F, Zias E, Jones MP, Pearlman S, Chertoff A, Wollowitz A, Gallagher EJ. Randomized Trial of Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain in the Emergency Department. Ann Emerg Med. 2019 Aug;74(2):233-240. doi: 10.1016/j.annemergmed.2019.01.021. Epub 2019 Feb 26.
PubMed 30819520

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Abdominal Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain. A Randomized Trial
ClinicalTrials.gov ID: NCT03300674
Acronym / sponsor ID: 2017-8408
Conditions: Abdominal Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Study start: 10 Jan 2018 (actual)
Primary completion: 16 Aug 2018 (actual)
Study completion: 28 Aug 2018 (actual)
First posted: 3 Oct 2017 (actual)
Results: Posted 26 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intravenous hydromorphone	Active comparator	Drug: HydromorphoneIntravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.
Intravenous lidocaine	Active comparator	Drug: LidocaineIntravenous lidocaine 120 mg. A second dose can be administered at 30 minutes

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
HydromorphoneHydromorphone intravenous infusion	Drug	Intravenous hydromorphone
LidocaineLidocaine intravenous infusion	Drug	Intravenous lidocaine

Primary outcome

Change in 0-10 Pain Scale Between Baseline and 90 Minutes
Time frame: 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

2 secondary outcomes

Rescue Medication
Time frame: 4 hours
Adverse Events
Time frame: 4 hours

Results and safety

Results posted to the registry on 26 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intravenous Hydromorphone	77	77
Intravenous Lidocaine	77	77

Primary outcome: Change in 0-10 Pain Scale Between Baseline and 90 Minutes

Time frame: up to 90 minutes. Mean (Standard Deviation). Unit: units on a scale

Measure	Intravenous Hydromorphone n = 77	Intravenous Lidocaine n = 77
Value	5.0 (2.8)	3.8 (2.2)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intravenous Hydromorphone	0 of 77 (0%)	28 of 77 (36.4%)	0 of 77
Intravenous Lidocaine	0 of 77 (0%)	23 of 77 (29.9%)	0 of 77

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30819520Chinn E, Friedman BW, Naeem F, Irizarry E, Afrifa F, Zias E, Jones MP, Pearlman S, Chertoff A, Wollowitz A, Gallagher EJ. Randomized Trial of Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain in the Emergency Department. Ann Emerg Med. 2019 Aug;74(2):233-240. doi: 10.1016/j.annemergmed.2019.01.021. Epub 2019 Feb 26.
Individual participant dataSharing planned: No

Related trials for Abdominal Pain

Not yet recruiting
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
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Active, not recruitingPhase 2
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Post Operative Analgesia
Active, not recruiting
Urinary Catheterization Versus No Catheterization in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair
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Active, not recruitingPhase 3
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Not yet recruiting
The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 Hydromorphone and Lidocaine in people with Abdominal Pain, run by Montefiore Medical Center 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?

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 10 Aug 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 26 Nov 2019). 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?

Change in 0-10 Pain Scale Between Baseline and 90 Minutes (time frame: up to 90 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03300674, which also lists 1 linked publication.

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 10 Aug 2020.