Conditions: Pain
Keywords: Pain Analgesia Analgesia, Patient-controlled Emergency Medicine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 211
Healthy volunteers: no

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.

Arms:
arm 1: 0.1 mg/kg morphine loading dose plus PCA with 1.0 mg morphine demand dosing every 6 minutes arm 2: 0.1 mg/kg morphine loading dose plus PCA with 1.5 mg morphine demand dosing every 6 minutes arm 3: 0.1 mg/kg morphine loading dose plus additional analgesia as needed

Interventions: intervention 1: Patient-controlled analgesia intervention 2: morphine
Intervention descriptions: intervention 1: Intravenous morphine delivered via Curlin painsmart PCA device intervention 2: Intravenous morphine

Protocol document: