Effectiveness and Feasibility of Patient Controlled Analgesia in the ED



Status:Completed
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 65
Updated:12/13/2018
Start Date:April 2013
End Date:February 2016

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Background: Inadequate pain management is common in the Emergency Department (ED). Optimal
treatment of pain necessitates titration to effective dose due to the large inter-individual
variability in opioid requirement. However nurse administered titration is difficult to
provide in this setting due to high patient to nurse and physician ratios and multiple urgent
competing patient demands. Patient controlled analgesia (PCA) lets ED patients actively
participate in pain management by allowing self-titration to their desired level of pain
relief. A tightly controlled randomized clinical trial (RCT) funded by NINR recently
completed by the investigators group provides promising preliminary support for the efficacy
and safety of PCA for patients with abdominal pain at a single ED with a dedicated research
nurse and standard loading dose given to all patients. Objective: The overall objective is to
provide optimal pain management in the ED. Specific aims: 1)To compare the effectiveness and
safety of PCA and non-PCA opioid analgesia when nurses involved in clinical care deliver the
intervention to a broad group of ED patients with acute pain at multiple clinical centers.
The primary hypothesis is that there will be a greater decline in pain over time and similar
safety in patients randomized to receive PCA compared to patients receiving standard opioid
analgesia. 2) To describe the feasibility of PCA in terms of patient and provider acceptance,
resource utilization and cost associated with PCA. Innovation: PCA represents a novel shift
from the current provider-driven model of ED pain management to one in which the patient is
an active participant. Few prior studies have evaluated ED PCA and no systematic evaluation
of time and resources exists. Methodology: An RCT will be performed at 3 clinical centers.
750 patients with acute pain warranting IV opioid administration will be randomized to
receive usual opioid analgesia determined by the provider or PCA (loading dose 0.1 mg/kg
morphine and demand dose of 1 mg morphine available every 6 minutes). Pain intensity will be
measured by a numerical rating scale recorded every half hour up to 2 hours after initial
opioid administration. Primary endpoints are rate of change in pain intensity from 30 minutes
after initial administration of opioid to 2 hours as suggested by the results of the
preliminary study and incidence of adverse events. PCA will also be compared to non-PCA
opioid analgesia assessed at the end of the 2 hour study period by patient satisfaction with
pain management; RN assessment of time efficiency/ease of use and satisfaction with pain
management; and physician satisfaction with pain management. Resource utilization and cost
associated with implementation and use of PCA in the ED setting will be assessed by total RN
time spent on pain management per patient; pharmacy preparation time per patient; material
cost per patient and RN and MD training time necessary for PCA implementation. Significance:
If PCA is demonstrated to be effective, safe, and associated with patient and provider
acceptance and acceptable resource utilization, it has the potential to significantly improve
ED pain management.


Inclusion Criteria:

1. Age 18 to 65

2. Patient deemed by the ED attending physician to require IV opioid analgesia for pain
and for whom the ED Attending Physician would consider using PCA

Exclusion Criteria:

1. Patients requiring initial resuscitation that would preclude the use of PCA

2. Long-term use of prescription or non-prescription opioids now or within the past year

3. Recent opioid use within the past 24 hours

4. Chronic pain syndromes

5. Clinician suspicion of current or past opioid dependence/abuse

6. Altered mental status/Clinical suspicion of intoxication

7. Patients expected to require conscious sedation while in the ED

8. Pregnancy or breast-feeding

9. History of chronic obstructive pulmonary disease, history of sleep apnea syndrome,
baseline oxygen saturation (room air) < 97%

10. Systolic blood pressure < 100 mm Hg

11. Use of sedative medications e.g. benzodiazepines, monoamine oxidase inhibitors,
phenothiazines, or tricyclic antidepressants.

12. History of renal insufficiency/renal failure

13. Prior allergic reaction to morphine

14. Inability to provide informed consent or inability to understand or operate PCA device

15. Previous entry of patient into study
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