Effectiveness and Feasibility of Patient Controlled Analgesia in the ED

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Jacobi Medical Center
Montefiore Medical Center
University of Pennsylvania
Information provided by (Responsible Party):
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01775371
First received: October 3, 2012
Last updated: May 16, 2013
Last verified: January 2013
  Purpose

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 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 determined by the provider or PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes). Pain intensity will be measured by a numerical rating scale recorded every half hour up to 2 hours after initial opioid administration. Primary endpoints are rate of change in pain intensity from 30 minutes after initial administration of opioid to 2 hours as suggested by the results of the preliminary study and incidence of adverse events. PCA will also be compared to non-PCA opioid analgesia assessed at the end of the 2 hour study period by patient satisfaction with pain management; RN assessment of time efficiency/ease of use and satisfaction with pain management; and physician satisfaction with pain management. Resource utilization and cost associated with implementation and use of PCA in the ED setting will be assessed by total RN time spent on pain management per patient; pharmacy preparation time per patient; material cost per patient and RN and MD training time necessary for PCA implementation. Significance: If PCA is demonstrated to be effective, safe, and associated with patient and provider acceptance and acceptable resource utilization, it has the potential to significantly improve ED pain management.


Condition Intervention
Pain
Procedure: Patient controlled analgesia
Procedure: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness and Feasibility of Patient Controlled Analgesia in the ED

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Rate of change in pain intensity [ Time Frame: From 30 minutes after initial administration of opioid to 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
  • Patient satisfaction with pain management [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • RN assessment of time efficiency/ease of use and satisfaction with pain management [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Physician satisfaction with pain management [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Resource utilization and cost associated with implementation and use of PCA in the ED setting [ Designated as safety issue: No ]
    • Total RN time spent on pain management per patient
    • Pharmacy preparation time per patient
    • Material cost per patient
    • RN and MD training time necessary for PCA implementation


Estimated Enrollment: 750
Study Start Date: April 2013
Arms Assigned Interventions
Experimental: Patient Controlled Analgesia
PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes)
Procedure: Patient controlled analgesia
Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes
Other Name: MOOG/Curlin PainSmart IOD Ambulatory Infusion System
Active Comparator: Usual Care
Usual opioid analgesia determined by the provider
Procedure: Usual Care
Usual opioid analgesia determined by the provider

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 to 65
  2. Patient deemed by the ED attending physician to require IV opioid analgesia for pain and for whom the ED Attending Physician would consider using PCA

Exclusion Criteria:

  1. Patients requiring initial resuscitation that would preclude the use of PCA
  2. Long-term use of prescription or non-prescription opioids now or within the past year
  3. Recent opioid use within the past 24 hours
  4. Chronic pain syndromes
  5. Clinician suspicion of current or past opioid dependence/abuse
  6. Altered mental status/Clinical suspicion of intoxication
  7. Patients expected to require conscious sedation while in the ED
  8. Pregnancy or breast-feeding
  9. History of chronic obstructive pulmonary disease, history of sleep apnea syndrome, baseline oxygen saturation (room air) < 97%
  10. Systolic blood pressure < 100 mm Hg
  11. Use of sedative medications e.g. benzodiazepines, monoamine oxidase inhibitors, phenothiazines, or tricyclic antidepressants.
  12. History of renal insufficiency/renal failure
  13. Prior allergic reaction to morphine
  14. Inability to provide informed consent or inability to understand or operate PCA device
  15. Previous entry of patient into study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01775371

Locations
United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Montefiore Medical Center - Moses Division
Bronx, New York, United States, 10467
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Jacobi Medical Center
Montefiore Medical Center
University of Pennsylvania
Investigators
Principal Investigator: Adrienne Birnbaum, MD, MS Albert Einstein College of Medicine, Jacobi Medical Center
Principal Investigator: Polly Bijur, PhD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01775371     History of Changes
Other Study ID Numbers: 2012-485, R01NR013980
Study First Received: October 3, 2012
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Pain
Emergency
Analgesia
ED patients
acute pain
IV opioid

Additional relevant MeSH terms:
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 24, 2014