N/A
N=211
Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department
Pain
Bottom Line
View on ClinicalTrials.gov: NCT00910208 ↗Enrolled (actual)
211
Serious AEs
1.0%
Results posted
Dec 2019
Primary outcome: Primary: Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale — 3.8; 4.0; 3.6 Units on a scale — p=0.82
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient-controlled analgesia (Device); morphine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale |
3.8; 4.0; 3.6 | 0.82 |
| PRIMARY Participants With Short Term Efficacy: Pain Relief by 30 Minutes |
4; 4; 4; 14; 10; 16 | 0.47 |
| PRIMARY Long Term Efficacy: Total Analgesia Provided Over 2 Hours |
-16.4; -17.4; -13.6 | 0.06 |
| PRIMARY Long Term Efficacy: Pain Relief by 120 Minutes |
7; 6; 6; 9; 5; 18 | 0.033 sig |
| PRIMARY Safety: Incidence of Adverse Events |
0; 1; 1; 67; 69; 68 | 0.99 |
| SECONDARY Need for Supplementary Analgesia |
4; 0; 20; 63; 70; 49 | <0.001 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00910208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.