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NCT01775371 · ClinicalTrials.gov registry record · NA

Effectiveness and Feasibility of Patient Controlled Analgesia in the ED

A NA study of Pain, sponsored by Albert Einstein College of Medicine.

Completed
Registry status
NA
Development phase
636
Enrollment target
3
Study locations

NCT01775371 is a NA study of Pain that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 636 participants, above the 303-participant average among 374 other Pain trials with a reported enrollment target (110% higher). The trial reports 3 study locations across 2 states.

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The verdict

NCT01775371, a NA study of Pain, has completed, sponsored by Albert Einstein College of Medicine.

COMPLETED
Registry status
NA
Development phase
636 participants
Enrollment target
3
Study locations

Study Summary

Background: Inadequate pain management is common in the Emergency Department (ED). Optimal treatment of pain necessitates titration to effective dose due to the large inter-individual variability in opioid requirement. However nurse administered titration is difficult to provide in this setting due to high patient to nurse and physician ratios and multiple urgent competing patient demands. Patient controlled analgesia (PCA) lets ED patients actively participate in pain management by allowing self-titration to their desired level of pain relief. A tightly controlled randomized clinical trial (RCT) funded by the National Institute of Nursing Research (NINR) recently completed by the investigators group provides promising preliminary support for the efficacy and safety of PCA for patients with abdominal pain at a single ED with a dedicated research nurse and standard loading dose given to all patients. Objective: The overall objective is to provide optimal pain management in the ED. Specific aims: 1)To compare the effectiveness and safety of PCA and non-PCA opioid analgesia when nurses involved in clinical care deliver the intervention to a broad group of ED patients with acute pain at multiple clinical centers. The primary hypothesis is that there will be a greater decline in pain over time and similar safety in patients randomized to receive PCA compared to patients receiving standard opioid analgesia. 2) To describe the feasibility of PCA in terms of patient and provider acceptance, resource utilization and cost associated with PCA. Innovation: PCA represents a novel shift from the current provider-driven model of ED pain management to one in which the patient is an active participant. Few prior studies have evaluated ED PCA and no systematic evaluation of time and resources exists. Methodology: An RCT will be performed at 3 clinical centers. 750 patients with acute pain warranting IV opioid administration will be randomized to receive usual opioid analgesia determi

Conditions Studied

Interventions

  • OTHER Usual Care
  • DEVICE Patient controlled analgesia (PCA)

Study Locations (3)

New York

  • Jacobi Medical Center - The Bronx
  • Montefiore Medical Center - Moses Division - The Bronx

Pennsylvania

  • University of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 636 participants
Start Date 2013-04
Est. Completion 2016-02
Phase NA

Sponsor

Albert Einstein College of Medicine

175 total trials

What the Registry Record Tells You About NCT01775371

The ClinicalTrials.gov registry entry for NCT01775371 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 636 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 303-participant average among 374 other Pain trials with a reported enrollment target (110% higher). The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.

NCT01775371 reports 3 study locations spanning 2 distinct geographic areas - top geographies include New York, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01775371 about?

NCT01775371 is a clinical study titled "Effectiveness and Feasibility of Patient Controlled Analgesia in the ED". Background: Inadequate pain management is common in the Emergency Department (ED). Optimal treatment of pain necessitates titration to effective dose due to the large inter-individual variability in opioid requirement. However nurse administered titration is difficult to provide in this setting due ...

What is the current status of trial NCT01775371?

This trial is currently completed. It is a NA study. The enrollment target is 636 participants. The study started on 2013-04. Estimated completion is 2016-02.

What conditions does trial NCT01775371 study?

This clinical trial studies the following conditions: Pain.

What interventions are being tested in trial NCT01775371?

The interventions under investigation include: Usual Care (OTHER), Patient controlled analgesia (PCA) (DEVICE).

Who is sponsoring clinical trial NCT01775371?

This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01775371 being conducted?

This trial has 3 study locations across New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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