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Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00910208
Recruitment Status : Completed
First Posted : May 29, 2009
Results First Posted : December 27, 2019
Last Update Posted : December 27, 2019
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

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Device: Patient-controlled analgesia Drug: morphine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department
Study Start Date : April 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient-controlled analgesia 1 mg demand dose
0.1 mg/kg morphine loading dose plus PCA with 1.0 mg morphine demand dosing every 6 minutes
Device: Patient-controlled analgesia
Intravenous morphine delivered via Curlin painsmart PCA device
Other Name: PCA

Drug: morphine
Intravenous morphine

Experimental: Patient-controlled analgesia 1.5 mg demand dose
0.1 mg/kg morphine loading dose plus PCA with 1.5 mg morphine demand dosing every 6 minutes
Device: Patient-controlled analgesia
Intravenous morphine delivered via Curlin painsmart PCA device
Other Name: PCA

Drug: morphine
Intravenous morphine

Active Comparator: Non-Patient-controlled analgesia comparison group
0.1 mg/kg morphine loading dose plus additional analgesia as needed
Drug: morphine
Intravenous morphine




Primary Outcome Measures :
  1. Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale [ Time Frame: Baseline and 30 minutes post treatment ]
    Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain. Change is measured by subtracting the 30 minute NRS score from the Baseline NRS score, thus higher numbers indicate greater decrease in pain, negative numbers indicate increase in pain from baseline to 30 minutes post-baseline.

  2. Participants With Short Term Efficacy: Pain Relief by 30 Minutes [ Time Frame: 30 minutes post treatment ]
    Pain Intensity measured on Likert Scale. Participants self report pain level according to the scale by selecting from No relief, Slight relief, Moderate relief, A lot of relief, and Complete relief)

  3. Long Term Efficacy: Total Analgesia Provided Over 2 Hours [ Time Frame: Baseline, 30, 60, 90, 120 post-treatment ]

    Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain

    Total analgesia is measured by a summary of change in pain that varies from 0 - no change to


  4. Long Term Efficacy: Pain Relief by 120 Minutes [ Time Frame: 120 minutes ]
    Participants aksed to and give range

  5. Safety: Incidence of Adverse Events [ Time Frame: 2 hours ]
    Adverse Events defined as: oxygen saturation < 92%; respiratory rate <10 breaths/min; systolic blood pressure < 90 mm Hg)


Secondary Outcome Measures :
  1. Need for Supplementary Analgesia [ Time Frame: 2 hours post treatment ]
    count of participants who needed or did not needed additional analgesia



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910208


Locations
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United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Jacobi Medical Center
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT00910208    
Other Study ID Numbers: 2008-448
1R21NR010929-01 ( U.S. NIH Grant/Contract )
First Posted: May 29, 2009    Key Record Dates
Results First Posted: December 27, 2019
Last Update Posted: December 27, 2019
Last Verified: December 2019
Keywords provided by Albert Einstein College of Medicine:
Pain
Analgesia
Analgesia, Patient-controlled
Emergency Medicine
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents