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NCT04398316 · ClinicalTrials.gov registry record · Phase 4

High Dose IV Lidocaine vs Hydromorphone for Abdominal Pain in the Emergency Department

A Phase 4 study, sponsored by Hennepin Healthcare Research Institute.

Terminated
Registry status
Phase 4
Development phase
4
Enrollment target

NCT04398316: Clinical Trial Phase 4 study, sponsored by Hennepin Healthcare Research Institute.

NCT04398316 is a Phase 4 study that was terminated before completion, run by Hennepin Healthcare Research Institute. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04398316, a Phase 4 study, was terminated before completion, sponsored by Hennepin Healthcare Research Institute.

TERMINATED
Registry status
Phase 4
Development phase
4 participants
Enrollment target

Study Summary

Intravenous lidocaine will be given at a dose of 2 mg/kg intravenously to patients in the emergency department with a diagnosis of acute abdominal pain. Its efficacy will be compared to 1 mg of intravenous hydromorphone, with a primary endpoint of mean improvement of pain at 90 minutes.

Primary Outcome

The difference between the pain score at time 0 and 90 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).

Interventions

  • DRUG Lidocaine Iv
  • DRUG HYDROmorphone Injection

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2021-02-18
Est. Completion 2021-06-30
Phase Phase 4

Why NCT04398316 stopped before completion

NCT04398316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Lidocaine Iv is the first listed.

NCT04398316 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04398316 about?

NCT04398316 is a clinical study titled "High Dose IV Lidocaine vs Hydromorphone for Abdominal Pain in the Emergency Department". Intravenous lidocaine will be given at a dose of 2 mg/kg intravenously to patients in the emergency department with a diagnosis of acute abdominal pain. Its efficacy will be compared to 1 mg of intravenous hydromorphone, with a primary endpoint of mean improvement of pain at 90 minutes.

What is the current status of trial NCT04398316?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2021-02-18. Estimated completion is 2021-06-30.

What interventions are being tested in trial NCT04398316?

The interventions under investigation include: Lidocaine Iv (DRUG), HYDROmorphone Injection (DRUG).

Who is sponsoring clinical trial NCT04398316?

This trial is sponsored by Hennepin Healthcare Research Institute, which has 63 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04398316's enrollment target sits among peer trials

4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04398316, the US trial registry maintained by the National Library of Medicine. NCT04398316 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.