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.
Brief Title
Intravenous Lidocaine Randomized Comparative Effectiveness Trial
Categories
Completion Date
Completion Date Type
Actual
Conditions
Abdominal Pain
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.
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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.
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Inclusion 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03300674
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2017-8408
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain. A Randomized Trial
Primary Outcomes
Outcome 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
Outcome Measure
Change in 0-10 Pain Scale Between Baseline and 90 Minutes
Outcome Time Frame
up to 90 minutes
Secondary Outcomes
Outcome Description
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
Outcome Time Frame
4 hours
Outcome Measure
Rescue Medication
Outcome Description
Any new symptom development after administration of investigational medication
Outcome Time Frame
4 hours
Outcome Measure
Adverse Events
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Friedman
Investigator Email
befriedm@montefiore.org
Investigator Phone
646-265-6415