Jacobi Medical Center
The Bronx, New York, 10461, United States
NCT Number: NCT00910208
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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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
The Bronx, New York, 10461, United States
The safety, efficacy, and dosing of PCA will be assessed in a randomized trial with three treatment arms:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous morphine delivered via Curlin painsmart PCA device
Other names: PCA
Intravenous morphine
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.
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)
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
Time frame: 120 minutes
Participants aksed to and give range
Time frame: 2 hours
Adverse Events defined as: oxygen saturation < 92%; respiratory rate <10 breaths/min; systolic blood pressure < 90 mm Hg)
Time frame: 2 hours post treatment
count of participants who needed or did not needed additional analgesia
Albert Einstein College of Medicine
Other
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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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