Effectiveness and Feasibility of Patient Controlled Analgesia in the ED
Condition: Pain
Study type: Interventional

Summary: 
      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 the National Institute
      of Nursing Research (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 (NRS) 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; registered nurse (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 Registered nurse (RN) time spent on pain
      management per patient; pharmacy preparation time per patient; material cost per patient and
      Registered Nurse and Physician 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.
    


Intervention name(s): Patient controlled analgesia (PCA); Usual Care
Intervention type(s): Device; Other
Intervention description(s): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes; Usual opioid analgesia determined by the provider
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Emergency; Analgesia; ED patients; acute pain; IV opioid