Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

Conditions
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Pain

Intervention / Treatment
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* Device: Patient-controlled analgesia
* Drug: morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient-controlled analgesia 1 mg demand dose<br>0.1 mg/kg morphine loading dose plus PCA with 1.0 mg morphine demand dosing every 6 minutes | Device: Patient-controlled analgesia<br>* Intravenous morphine delivered via Curlin painsmart PCA device<br>* Other names: PCA;Drug: morphine<br>* Intravenous morphine<br>|
| Experimental: Patient-controlled analgesia 1.5 mg demand dose<br>0.1 mg/kg morphine loading dose plus PCA with 1.5 mg morphine demand dosing every 6 minutes | Device: Patient-controlled analgesia<br>* Intravenous morphine delivered via Curlin painsmart PCA device<br>* Other names: PCA;Drug: morphine<br>* Intravenous morphine<br>|
| Active Comparator: Non-Patient-controlled analgesia comparison group<br>0.1 mg/kg morphine loading dose plus additional analgesia as needed | Drug: morphine<br>* Intravenous morphine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Long Term Efficacy: Pain Relief by 120 Minutes | Participants aksed to and give range | 120 minutes | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for Supplementary Analgesia | count of participants who needed or did not needed additional analgesia | 2 hours post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Analgesia, Analgesia, Patient-controlled, Emergency Medicine