Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

Not Applicable

Completed

Conditions: Pain

Interventions: Device: Patient-controlled analgesia
Drug: morphine

Registration Number: NCT00910208

Lead Sponsor: Albert Einstein College of Medicine

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 211

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient-controlled analgesia 1 mg demand dose	Patient-controlled analgesia	0.1 mg/kg morphine loading dose plus PCA with 1.0 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia 1 mg demand dose	morphine	0.1 mg/kg morphine loading dose plus PCA with 1.0 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia 1.5 mg demand dose	Patient-controlled analgesia	0.1 mg/kg morphine loading dose plus PCA with 1.5 mg morphine demand dosing every 6 minutes
Patient-controlled analgesia 1.5 mg demand dose	morphine	0.1 mg/kg morphine loading dose plus PCA with 1.5 mg morphine demand dosing every 6 minutes
Non-Patient-controlled analgesia comparison group	morphine	0.1 mg/kg morphine loading dose plus additional analgesia as needed

Primary Outcome Measures

Name	Time	Method
Participants With Short Term Efficacy: Pain Relief by 30 Minutes	30 minutes post treatment	Pain Intensity measured on Likert Scale. Participants self report pain level according to the scale by selecting from No relief, Slight relief, Moderate relief, A lot of relief, and Complete relief)
Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale	Baseline and 30 minutes post treatment	Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain. Change is measured by subtracting the 30 minute NRS score from the Baseline NRS score, thus higher numbers indicate greater decrease in pain, negative numbers indicate increase in pain from baseline to 30 minutes post-baseline.
Long Term Efficacy: Total Analgesia Provided Over 2 Hours	Baseline, 30, 60, 90, 120 post-treatment	Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain Total analgesia is measured by a summary of change in pain that varies from 0 - no change to
Long Term Efficacy: Pain Relief by 120 Minutes	120 minutes	Participants aksed to and give range
Safety: Incidence of Adverse Events	2 hours	Adverse Events defined as: oxygen saturation \< 92%; respiratory rate \<10 breaths/min; systolic blood pressure \< 90 mm Hg)