Intravenous Lidocaine Randomized Comparative Effectiveness Trial
Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain. A Randomized Trial
1 other identifier
interventional
154
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2018
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2017
CompletedFirst Posted
Study publicly available on registry
October 3, 2017
CompletedStudy Start
First participant enrolled
January 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2018
CompletedResults Posted
Study results publicly available
November 26, 2019
CompletedAugust 10, 2020
July 1, 2020
7 months
September 28, 2017
November 7, 2019
July 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
up to 90 minutes
Secondary Outcomes (2)
Rescue Medication
4 hours
Adverse Events
4 hours
Study Arms (2)
Intravenous hydromorphone
ACTIVE COMPARATORIntravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.
Intravenous lidocaine
ACTIVE COMPARATORIntravenous lidocaine 120 mg. A second dose can be administered at 30 minutes
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10467, United States
Related Publications (1)
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.
PMID: 30819520DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Benjamin W. Friedman
- Organization
- Montefiore
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 28, 2017
First Posted
October 3, 2017
Study Start
January 10, 2018
Primary Completion
August 16, 2018
Study Completion
August 28, 2018
Last Updated
August 10, 2020
Results First Posted
November 26, 2019
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share