Text Size

Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Jacobi Medical Center
Information provided by (Responsible Party):
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00910208
First received: May 27, 2009
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  Purpose

The aims of this study are to assess efficacy and safety of patient-controlled analgesia (PCA) when applied to the Emergency Department setting and to compare the efficacy and safety of two PCA dosing regimens.


Condition Intervention
Pain
 Device: Patient-controlled analgesia
Drug: morphine

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Short-term pain relief: Change in pain intensity from baseline to 30 minutes; Pain relief at 30 minutes [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Long-term pain relief: Total analgesia provided over 2 hours; Pain relief at 2 hours [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Incidence of adverse events: Oxygen saturation < 92%; respiratory rate <10 breaths/min; systolic blood pressure < 90 mm Hg) [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Need for supplementary analgesia [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment: 211
Study Start Date: April 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCA 1 mg demand dose
0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dosing every 6 minutes
 Device: Patient-controlled analgesia
Intravenous morphine delivered via Curlin painsmart PCA device
Drug: morphine
Intravenous morphine
Experimental: PCA 1.5 mg demand dose
0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes
 Device: Patient-controlled analgesia
Intravenous morphine delivered via Curlin painsmart PCA device
Drug: morphine
Intravenous morphine
Active Comparator: Non-PCA comparison group
0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain.
 Drug: morphine
Intravenous morphine

Detailed Description:

The safety, efficacy, and dosing of PCA will be assessed in a randomized trial with three treatment arms:

  1. PCA with 1.0 mg morphine demand dosing every 6 minutes,
  2. PCA with 1.5 mg demand dosing every 6 minutes and
  3. a non-PCA comparison group.

All patients will receive a loading dose of 0.1 mg/kg morphine. All patients can receive additional analgesics as needed, at the discretion of the provider.

We hypothesize that morphine supplied via PCA will provide superior analgesia without a greater incidence of adverse events when compared to non-PCA pain management; and that PCA demand dosing of 1.5 mg will be superior to 1.0 mg without more adverse events.

  Eligibility

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

Inclusion Criteria:

  • Patients presenting to the ED with a chief complaint of abdominal pain of less than or equal to 7 days duration
  • Age 18 to 65 years
  • Patient deemed by the ED attending physician to require IV opioid analgesia

Exclusion Criteria:

  • Current use of prescription or non-prescription opioids
  • Long-term use of opioids, chronic pain syndrome
  • Clinician suspicion of opioid dependence/abuse
  • Clinical suspicion of intoxication
  • Pregnancy or breast-feeding
  • History of chronic obstructive pulmonary disease, history of sleep apnea, oxygen saturation < 97%
  • Systolic blood pressure < 100 mm Hg
  • Use of monoamine oxidase inhibitors, phenothiazines, or tricyclic antidepressants
  • History of renal insufficiency/renal failure
  • Prior allergic reaction to morphine
  • Inability to provide informed consent
  • Previous entry of patient into study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910208

Locations
United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Jacobi Medical Center
Investigators
Principal Investigator: Adrienne J Birnbaum, MD, MS Jacobi Medical Center, Albert Einstein College of Medicine
Principal Investigator: Polly E Bijur, PhD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided by Albert Einstein College of Medicine of Yeshiva University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT00910208     History of Changes
Other Study ID Numbers: 2008-448, 1R21NR010929-01
Study First Received: May 27, 2009
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Pain
Analgesia
Analgesia, Patient-controlled
Emergency Medicine

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Morphine
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
Narcotics

ClinicalTrials.gov processed this record on May 19, 2013