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Completed

NCT Number: NCT00910208

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jacobi Medical Center

The Bronx, New York, 10461, United States

About this study

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

  • PCA with 1.0 mg morphine demand dosing every 6 minutes,
  • PCA with 1.5 mg demand dosing every 6 minutes and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-controlled analgesia

Device

Intravenous morphine delivered via Curlin painsmart PCA device

Other names: PCA

Morphine

Drug

Intravenous morphine

Primary outcomes

  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 outcomes

  1. Need for Supplementary Analgesia

    Time frame: 2 hours post treatment

    count of participants who needed or did not needed additional analgesia

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • Jacobi Medical Center
  • National Institute of Nursing Research (NINR)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 29, 2009
Registry last updated
Dec 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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