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Intravenous Lidocaine Randomized Comparative Effectiveness Trial

Primary Purpose

Abdominal Pain

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Hydromorphone

Lidocaine

About this trial

This is an interventional treatment trial for Abdominal Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Intravenous hydromorphone

Intravenous lidocaine

Arm Description

Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.

Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Adverse Events

Any new symptom development after administration of investigational medication

Full Information

NCT ID

NCT03300674

First Posted

September 28, 2017

Last Updated

July 29, 2020

Sponsor

Montefiore Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03300674

Brief Title

Intravenous Lidocaine Randomized Comparative Effectiveness Trial

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

January 10, 2018 (Actual)

Primary Completion Date

August 16, 2018 (Actual)

Study Completion Date

August 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abdominal Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double-blind

Allocation

Randomized

Enrollment

154 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intravenous hydromorphone

Arm Type

Active Comparator

Arm Description

Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.

Arm Title

Intravenous lidocaine

Arm Type

Active Comparator

Arm Description

Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes

Intervention Type

Drug

Intervention Name(s)

Hydromorphone

Intervention Description

Hydromorphone intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Description

Lidocaine intravenous infusion

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

up to 90 minutes

Secondary Outcome Measure Information:

Title

Rescue Medication

Description

Time Frame

4 hours

Title

Adverse Events

Description

Any new symptom development after administration of investigational medication

Time Frame

4 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Facility Information:

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30819520

Citation

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.

Results Reference

derived

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Intravenous Lidocaine Randomized Comparative Effectiveness Trial

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