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Completed

NCT Number: NCT03300674

Intravenous Lidocaine Randomized Comparative Effectiveness Trial

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.

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Key information

Conditions

Abdominal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Hydromorphone

Drug

Hydromorphone intravenous infusion

Lidocaine

Drug

Lidocaine intravenous infusion

Primary outcomes

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

    Time frame: up to 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 outcomes

  1. Rescue Medication

    Time frame: 4 hours

    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

  2. Adverse Events

    Time frame: 4 hours

    Any new symptom development after administration of investigational medication

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 3, 2017
Registry last updated
Aug 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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