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Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

This study has been completed.
Sponsor:
Collaborators:
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

May 27, 2009
July 12, 2012
April 2009
June 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00910208 on ClinicalTrials.gov Archive Site
Need for supplementary analgesia [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department
Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
  • Device: Patient-controlled analgesia
    Intravenous morphine delivered via Curlin painsmart PCA device
  • Drug: morphine
    Intravenous morphine
  • 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
    Interventions:
    • Device: Patient-controlled analgesia
    • Drug: 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
    Interventions:
    • Device: Patient-controlled analgesia
    • Drug: 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.
    Intervention: Drug: morphine
Birnbaum A, Schechter C, Tufaro V, Touger R, Gallagher EJ, Bijur P. Efficacy of patient-controlled analgesia for patients with acute abdominal pain in the emergency department: a randomized trial. Acad Emerg Med. 2012 Apr;19(4):370-7. doi: 10.1111/j.1553-2712.2012.01322.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
211
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00910208
2008-448, 1R21NR010929-01
Yes
Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
  • National Institutes of Health (NIH)
  • National Institute of Nursing Research (NINR)
  • Jacobi Medical Center
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
Albert Einstein College of Medicine of Yeshiva University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP