Pain
Conditions
Keywords
Pain, Analgesia, Analgesia, Patient-controlled, Emergency 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.
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.
Interventions
DEVICEPatient-controlled analgesia
Intravenous morphine delivered via Curlin painsmart PCA device
DRUGmorphine
Intravenous morphine
Sponsors
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Jacobi Medical Center
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale | 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. |
| Participants With Short Term Efficacy: Pain Relief by 30 Minutes | 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) |
| Long Term Efficacy: Total Analgesia Provided Over 2 Hours | 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 |
| Long Term Efficacy: Pain Relief by 120 Minutes | 120 minutes | Participants aksed to and give range |
| Safety: Incidence of Adverse Events | 2 hours | Adverse Events defined as: oxygen saturation \< 92%; respiratory rate \<10 breaths/min; systolic blood pressure \< 90 mm Hg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for Supplementary Analgesia | 2 hours post treatment | count of participants who needed or did not needed additional analgesia |
Countries
United States
Participant flow
Recruitment details
Recruitment started April 3, 2009 and ended June 30, 2010. Patients were recruited by bilingual research associates in the Emergency Department of Jacobi Medical Center, Bronx, NY
Participants by arm
| Arm | Count |
|---|---|
| PCA 1 mg Demand Dose 0.1 mg/kg morphine loading dose followed by PCA with 1.0 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine | 67 |
| PCA 1.5 mg Demand Dose 0.1 mg/kg morphine loading dose followed by PCA with 1.5 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia: Intravenous morphine delivered via Curlin painsmart PCA device
morphine: Intravenous morphine | 70 |
| Non-PCA Comparison Group 0.1 mg/kg morphine loading dose followed by additional analgesia supplemented as needed at the discretion of the treating physician, using usual procedures for monitoring and treating pain.
morphine: Intravenous morphine | 69 |
| Total | 206 |
Baseline characteristics
| Characteristic | Non-PCA Comparison Group | Total | PCA 1 mg Demand Dose | PCA 1.5 mg Demand Dose |
|---|---|---|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 12 | 36 years STANDARD_DEVIATION 11 | 34 years STANDARD_DEVIATION 10 | 38 years STANDARD_DEVIATION 12 |
| Initial Pain Score Pain Score=10 | 31 Participants | 100 Participants | 37 Participants | 32 Participants |
| Initial Pain Score Pain Score=7 | 13 Participants | 24 Participants | 5 Participants | 6 Participants |
| Initial Pain Score Pain Score=8 | 10 Participants | 35 Participants | 8 Participants | 17 Participants |
| Initial Pain Score Pain Score=9 | 11 Participants | 33 Participants | 11 Participants | 11 Participants |
| Initial Pain Score Pain Score less than 7 | 4 Participants | 14 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian/other | 2 Participants | 14 Participants | 7 Participants | 5 Participants |
| Race/Ethnicity, Customized Black/African American - not Hispanic | 25 Participants | 56 Participants | 16 Participants | 15 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 37 Participants | 124 Participants | 41 Participants | 46 Participants |
| Race/Ethnicity, Customized White - not Hispanic | 5 Participants | 12 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Female | 51 Participants | 141 Participants | 43 Participants | 47 Participants |
| Sex: Female, Male Male | 18 Participants | 65 Participants | 24 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 70 | 0 / 69 |
| other Total, other adverse events | 1 / 67 | 0 / 70 | 0 / 69 |
| serious Total, serious adverse events | 0 / 67 | 1 / 70 | 1 / 69 |
Outcome results
Primary
Long Term Efficacy: Pain Relief by 120 Minutes
Participants aksed to and give range
Time frame: 120 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PCA 1 mg Demand Dose | Long Term Efficacy: Pain Relief by 120 Minutes | No relief | 7 Participants |
| PCA 1 mg Demand Dose | Long Term Efficacy: Pain Relief by 120 Minutes | A lot of relief | 22 Participants |
| PCA 1 mg Demand Dose | Long Term Efficacy: Pain Relief by 120 Minutes | Moderate relief | 9 Participants |
| PCA 1 mg Demand Dose | Long Term Efficacy: Pain Relief by 120 Minutes | Complete relief | 18 Participants |
| PCA 1 mg Demand Dose | Long Term Efficacy: Pain Relief by 120 Minutes | Slight relief | 9 Participants |
| PCA 1.5 mg Demand Dose | Long Term Efficacy: Pain Relief by 120 Minutes | Moderate relief | 8 Participants |
| PCA 1.5 mg Demand Dose | Long Term Efficacy: Pain Relief by 120 Minutes | No relief | 6 Participants |
| PCA 1.5 mg Demand Dose | Long Term Efficacy: Pain Relief by 120 Minutes | Slight relief | 5 Participants |
| PCA 1.5 mg Demand Dose | Long Term Efficacy: Pain Relief by 120 Minutes | A lot of relief | 34 Participants |
| PCA 1.5 mg Demand Dose | Long Term Efficacy: Pain Relief by 120 Minutes | Complete relief | 16 Participants |
| Non-PCA Comparison Group | Long Term Efficacy: Pain Relief by 120 Minutes | Complete relief | 15 Participants |
| Non-PCA Comparison Group | Long Term Efficacy: Pain Relief by 120 Minutes | A lot of relief | 16 Participants |
| Non-PCA Comparison Group | Long Term Efficacy: Pain Relief by 120 Minutes | No relief | 6 Participants |
| Non-PCA Comparison Group | Long Term Efficacy: Pain Relief by 120 Minutes | Moderate relief | 13 Participants |
| Non-PCA Comparison Group | Long Term Efficacy: Pain Relief by 120 Minutes | Slight relief | 18 Participants |
p-value: 0.033Chi-squared
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
Time frame: Baseline, 30, 60, 90, 120 post-treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PCA 1 mg Demand Dose | Long Term Efficacy: Total Analgesia Provided Over 2 Hours | -16.4 scores on a scale *minutes |
| PCA 1.5 mg Demand Dose | Long Term Efficacy: Total Analgesia Provided Over 2 Hours | -17.4 scores on a scale *minutes |
| Non-PCA Comparison Group | Long Term Efficacy: Total Analgesia Provided Over 2 Hours | -13.6 scores on a scale *minutes |
p-value: 0.06ANOVA
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)
Time frame: 30 minutes post treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PCA 1 mg Demand Dose | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | A lot of relief | 24 Participants |
| PCA 1 mg Demand Dose | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | Moderate relief | 18 Participants |
| PCA 1 mg Demand Dose | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | No relief | 4 Participants |
| PCA 1 mg Demand Dose | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | Slight relief | 14 Participants |
| PCA 1 mg Demand Dose | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | Complete relief | 7 Participants |
| PCA 1.5 mg Demand Dose | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | Moderate relief | 20 Participants |
| PCA 1.5 mg Demand Dose | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | No relief | 4 Participants |
| PCA 1.5 mg Demand Dose | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | Slight relief | 10 Participants |
| PCA 1.5 mg Demand Dose | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | A lot of relief | 31 Participants |
| PCA 1.5 mg Demand Dose | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | Complete relief | 5 Participants |
| Non-PCA Comparison Group | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | Complete relief | 12 Participants |
| Non-PCA Comparison Group | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | A lot of relief | 25 Participants |
| Non-PCA Comparison Group | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | No relief | 4 Participants |
| Non-PCA Comparison Group | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | Moderate relief | 12 Participants |
| Non-PCA Comparison Group | Participants With Short Term Efficacy: Pain Relief by 30 Minutes | Slight relief | 16 Participants |
p-value: 0.47Chi-squared
Primary
Safety: Incidence of Adverse Events
Adverse Events defined as: oxygen saturation \< 92%; respiratory rate \<10 breaths/min; systolic blood pressure \< 90 mm Hg)
Time frame: 2 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PCA 1 mg Demand Dose | Safety: Incidence of Adverse Events | 1 or more adverse events | 0 Participants |
| PCA 1 mg Demand Dose | Safety: Incidence of Adverse Events | No Adverse events | 67 Participants |
| PCA 1.5 mg Demand Dose | Safety: Incidence of Adverse Events | 1 or more adverse events | 1 Participants |
| PCA 1.5 mg Demand Dose | Safety: Incidence of Adverse Events | No Adverse events | 69 Participants |
| Non-PCA Comparison Group | Safety: Incidence of Adverse Events | 1 or more adverse events | 1 Participants |
| Non-PCA Comparison Group | Safety: Incidence of Adverse Events | No Adverse events | 68 Participants |
p-value: 0.99Fisher Exact
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.
Time frame: Baseline and 30 minutes post treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PCA 1 mg Demand Dose | Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale | 3.8 Units on a scale |
| PCA 1.5 mg Demand Dose | Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale | 4.0 Units on a scale |
| Non-PCA Comparison Group | Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale | 3.6 Units on a scale |
p-value: 0.82ANOVA
Secondary
Need for Supplementary Analgesia
count of participants who needed or did not needed additional analgesia
Time frame: 2 hours post treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PCA 1 mg Demand Dose | Need for Supplementary Analgesia | Needed supplementary medication | 4 Participants |
| PCA 1 mg Demand Dose | Need for Supplementary Analgesia | Did not need supplementary medication | 63 Participants |
| PCA 1.5 mg Demand Dose | Need for Supplementary Analgesia | Needed supplementary medication | 0 Participants |
| PCA 1.5 mg Demand Dose | Need for Supplementary Analgesia | Did not need supplementary medication | 70 Participants |
| Non-PCA Comparison Group | Need for Supplementary Analgesia | Needed supplementary medication | 20 Participants |
| Non-PCA Comparison Group | Need for Supplementary Analgesia | Did not need supplementary medication | 49 Participants |
p-value: <0.001Fisher Exact