Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

Albert Einstein College of Medicine211 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

211

Conditions

Pain

Interventions

Patient-controlled analgesiaDEVICE

Intravenous morphine delivered via Curlin painsmart PCA device

morphineDRUG

Intravenous morphine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Jacobi Medical Center

The Bronx, New York, United States

Outcomes

Primary Outcomes

Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale

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.

Time frame: Baseline and 30 minutes post treatment

Participants With Short Term Efficacy: Pain Relief by 30 Minutes

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)

Time frame: 30 minutes post treatment

Long Term Efficacy: Total Analgesia Provided Over 2 Hours

Time frame: Baseline, 30, 60, 90, 120 post-treatment

Long Term Efficacy: Pain Relief by 120 Minutes

Participants aksed to and give range

Time frame: 120 minutes

Safety: Incidence of Adverse Events

Adverse Events defined as: oxygen saturation \< 92%; respiratory rate \<10 breaths/min; systolic blood pressure \< 90 mm Hg)

Time frame: 2 hours

Secondary Outcomes

Need for Supplementary Analgesia

Data from ClinicalTrials.gov

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