Intravenous Lidocaine Randomized Comparative Effectiveness Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Abdominal Pain

Intervention / Treatment
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* Drug: Hydromorphone
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous hydromorphone<br>Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes. | Drug: Hydromorphone<br>* Hydromorphone intravenous infusion<br>|
| Active Comparator: Intravenous lidocaine<br>Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes | Drug: Lidocaine<br>* Lidocaine intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 hours | 
| Adverse Events | Any new symptom development after administration of investigational medication | 4 hours |