Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blind

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Intravenous hydromorphone
Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.
  • Drug: Hydromorphone
    Hydromorphone intravenous infusion
Active Comparator
Intravenous lidocaine
Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes
  • Drug: Lidocaine
    Lidocaine intravenous infusion

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Benjamin Friedman, MD, MS
718-920-6626
befriedm@montefiore.org

More Details

NCT ID
NCT03300674
Status
Recruiting
Sponsor
Montefiore Medical Center

Study Contact

Benjamin W Friedman, MD, MS
7189206626
befriedm@montefiore.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.