Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

Albert Einstein College of Medicine

Status: Completed

Conditions: Pain

Treatments: Drug: morphine; Device: Patient-controlled analgesia

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00910208

1R21NR010929-01 (U.S. NIH Grant/Contract)

2008-448

Details and patient eligibility

About

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.

Full 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.

Enrollment: 211 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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211 participants in 3 patient groups

Patient-controlled analgesia 1 mg demand dose

Experimental group

Description:

0.1 mg/kg morphine loading dose plus PCA with 1.0 mg morphine demand dosing every 6 minutes

Treatment:

Device: Patient-controlled analgesia

Drug: morphine

Patient-controlled analgesia 1.5 mg demand dose

Experimental group

Description:

0.1 mg/kg morphine loading dose plus PCA with 1.5 mg morphine demand dosing every 6 minutes

Treatment:

Device: Patient-controlled analgesia

Drug: morphine

Non-Patient-controlled analgesia comparison group

Active Comparator group

Description:

0.1 mg/kg morphine loading dose plus additional analgesia as needed

Treatment:

Drug: morphine