Pain Clinical Trial
Official title:
Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department
Verified date | December 2019 |
Source | Albert Einstein College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 211 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Jacobi Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Albert Einstein College of Medicine | Jacobi Medical Center, National Institute of Nursing Research (NINR), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale | 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. | Baseline and 30 minutes post treatment | |
Primary | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | 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) | 30 minutes post treatment | |
Primary | Long Term Efficacy: Total Analgesia Provided Over 2 Hours | 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 |
Baseline, 30, 60, 90, 120 post-treatment | |
Primary | Long Term Efficacy: Pain Relief by 120 Minutes | Participants aksed to and give range | 120 minutes | |
Primary | Safety: Incidence of Adverse Events | Adverse Events defined as: oxygen saturation < 92%; respiratory rate <10 breaths/min; systolic blood pressure < 90 mm Hg) | 2 hours | |
Secondary | Need for Supplementary Analgesia | count of participants who needed or did not needed additional analgesia | 2 hours post treatment |
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