Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: Patient-controlled analgesia; Drug: morphine

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.

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Jacobi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient-controlled analgesia 1 mg demand dose; 0.1 mg/kg morphine loading dose plus PCA with 1.0 mg morphine demand dosing every 6 minutes	Device: Patient-controlled analgesia; Intravenous morphine delivered via Curlin painsmart PCA device; Other Names: PCA; Drug: morphine; Intravenous morphine
Experimental: Patient-controlled analgesia 1.5 mg demand dose; 0.1 mg/kg morphine loading dose plus PCA with 1.5 mg morphine demand dosing every 6 minutes	Device: Patient-controlled analgesia; Intravenous morphine delivered via Curlin painsmart PCA device; Other Names: PCA; Drug: morphine; Intravenous morphine
Active Comparator: Non-Patient-controlled analgesia comparison group; 0.1 mg/kg morphine loading dose plus additional analgesia as needed	Drug: morphine; Intravenous morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	30 minutes post treatment
Long Term Efficacy: Total Analgesia Provided Over 2 Hours	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	Baseline, 30, 60, 90, 120 post-treatment
Long Term Efficacy: Pain Relief by 120 Minutes	Participants aksed to and give range	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)	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for Supplementary Analgesia	count of participants who needed or did not needed additional analgesia	2 hours post treatment

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Institute of Nursing Research (NINR); National Institutes of Health (NIH); Jacobi Medical Center
• Investigators: Principal Investigator: Adrienne J Birnbaum, MD, MS, Jacobi Medical Center, Albert Einstein College of Medicine; Principal Investigator: Polly E Bijur, PhD, Albert Einstein College of Medicine

Publications and helpful links

General Publications

• Birnbaum A, Schechter C, Tufaro V, Touger R, Gallagher EJ, Bijur P. Efficacy of patient-controlled analgesia for patients with acute abdominal pain in the emergency department: a randomized trial. Acad Emerg Med. 2012 Apr;19(4):370-7. doi: 10.1111/j.1553-2712.2012.01322.x.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: May 27, 2009
• First Submitted That Met QC Criteria: May 28, 2009
• First Posted (Estimate): May 29, 2009

Study Record Updates

• Last Update Posted (Actual): December 27, 2019
• Last Update Submitted That Met QC Criteria: December 26, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Pain; Analgesia; Emergency Medicine; Analgesia, Patient-controlled
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 2008-448; 1R21NR010929-01 (U.S. NIH Grant/Contract)