Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Pain, sponsored by Albert Einstein College of Medicine.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Rate of Change in Numerical Rating Scale (NRS) of Pain per hour where 0 indicates "no pain", 10 indicates "worst possible pain" between 30 minutes and 120 minutes post-baseline i.e. NRS at 30 minutes minus NRS at 120 minutes post-baseline.
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
| Field | Value |
|---|---|
| Enrollment Target | 636 participants |
| Start Date | 2013-04 |
| Est. Completion | 2016-02 |
| Phase | NA |
What the finished NCT01775371 record still lists
NCT01775371 is an interventional study that assigns participants to a tested intervention. The registered 636 participants enrollment target is mid-sized for trials with a published cap, above the 303-participant average among 374 other Pain trials with a reported enrollment target (110% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01775371's enrollment target sits among peer trials
636 22nd of 374 higher than 353 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain 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
-
Postoperative Pain After Activation of Irrigant
RECRUITING · NA
-
Neural Mechanisms of Immersive Virtual Reality in Chronic Pain (VR TMD EEG)
RECRUITING · NA
-
Pain With Dementia
RECRUITING · NA
-
Oklahoma Study of Native American Pain Risk IV: Smoking Cessation and Pain
RECRUITING · NA
-
Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain
RECRUITING · NA
-
TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03821129 · 636 participants · NA
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
- NCT03478826 · 635 participants
Creation of a Biospecimen Repository From Patients With Interstitial Lung Diseases (ILD)
- NCT00573027 · 634 participants · NA
Heart Disease of the Small Arteries in Women and Men
- NCT04108156 · 634 participants · Phase 3
A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia