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Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient-controlled analgesia
morphine
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Analgesia, Analgesia, Patient-controlled, Emergency Medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Jacobi Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Patient-controlled analgesia 1 mg demand dose

Patient-controlled analgesia 1.5 mg demand dose

Non-Patient-controlled analgesia comparison group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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)
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
Long Term Efficacy: Pain Relief by 120 Minutes
Participants aksed to and give range
Safety: Incidence of Adverse Events
Adverse Events defined as: oxygen saturation < 92%; respiratory rate <10 breaths/min; systolic blood pressure < 90 mm Hg)

Secondary Outcome Measures

Need for Supplementary Analgesia
count of participants who needed or did not needed additional analgesia

Full Information

First Posted
May 27, 2009
Last Updated
December 26, 2019
Sponsor
Albert Einstein College of Medicine
Collaborators
National Institutes of Health (NIH), National Institute of Nursing Research (NINR), Jacobi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00910208
Brief Title
Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department
Official Title
Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Institutes of Health (NIH), National Institute of Nursing Research (NINR), Jacobi Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: PCA with 1.0 mg morphine demand dosing every 6 minutes, PCA with 1.5 mg demand dosing every 6 minutes and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Pain, Analgesia, Analgesia, Patient-controlled, Emergency Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient-controlled analgesia 1 mg demand dose
Arm Type
Experimental
Arm Description
0.1 mg/kg morphine loading dose plus PCA with 1.0 mg morphine demand dosing every 6 minutes
Arm Title
Patient-controlled analgesia 1.5 mg demand dose
Arm Type
Experimental
Arm Description
0.1 mg/kg morphine loading dose plus PCA with 1.5 mg morphine demand dosing every 6 minutes
Arm Title
Non-Patient-controlled analgesia comparison group
Arm Type
Active Comparator
Arm Description
0.1 mg/kg morphine loading dose plus additional analgesia as needed
Intervention Type
Device
Intervention Name(s)
Patient-controlled analgesia
Other Intervention Name(s)
PCA
Intervention Description
Intravenous morphine delivered via Curlin painsmart PCA device
Intervention Type
Drug
Intervention Name(s)
morphine
Intervention Description
Intravenous morphine
Primary Outcome Measure Information:
Title
Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale
Description
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
Title
Participants With Short Term Efficacy: Pain Relief by 30 Minutes
Description
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
Title
Long Term Efficacy: Total Analgesia Provided Over 2 Hours
Description
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
Time Frame
Baseline, 30, 60, 90, 120 post-treatment
Title
Long Term Efficacy: Pain Relief by 120 Minutes
Description
Participants aksed to and give range
Time Frame
120 minutes
Title
Safety: Incidence of Adverse Events
Description
Adverse Events defined as: oxygen saturation < 92%; respiratory rate <10 breaths/min; systolic blood pressure < 90 mm Hg)
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Need for Supplementary Analgesia
Description
count of participants who needed or did not needed additional analgesia
Time Frame
2 hours post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrienne J Birnbaum, MD, MS
Organizational Affiliation
Jacobi Medical Center, Albert Einstein College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Polly E Bijur, PhD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22506940
Citation
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.
Results Reference
derived

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Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

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