Effectiveness and Feasibility of Patient Controlled Analgesia in the ED

• Sponsor: Albert Einstein College of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01775371
• Collaborator: Jacobi Medical Center (Other), Montefiore Medical Center (Other), University of Pennsylvania (Other), National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 636
• Locations: 3
• Arms: 2
• Actual Duration (Months): 34
• Patients Per Site: 212
• Patients Per Site Per Month: 6.2

Study Details

Study Description

Brief Summary

Background: Inadequate pain management is common in the Emergency Department (ED). Optimal treatment of pain necessitates titration to effective dose due to the large inter-individual variability in opioid requirement. However nurse administered titration is difficult to provide in this setting due to high patient to nurse and physician ratios and multiple urgent competing patient demands. Patient controlled analgesia (PCA) lets ED patients actively participate in pain management by allowing self-titration to their desired level of pain relief. A tightly controlled randomized clinical trial (RCT) funded by the National Institute of Nursing Research (NINR) recently completed by the investigators group provides promising preliminary support for the efficacy and safety of PCA for patients with abdominal pain at a single ED with a dedicated research nurse and standard loading dose given to all patients. Objective: The overall objective is to provide optimal pain management in the ED. Specific aims: 1)To compare the effectiveness and safety of PCA and non-PCA opioid analgesia when nurses involved in clinical care deliver the intervention to a broad group of ED patients with acute pain at multiple clinical centers. The primary hypothesis is that there will be a greater decline in pain over time and similar safety in patients randomized to receive PCA compared to patients receiving standard opioid analgesia. 2) To describe the feasibility of PCA in terms of patient and provider acceptance, resource utilization and cost associated with PCA. Innovation: PCA represents a novel shift from the current provider-driven model of ED pain management to one in which the patient is an active participant. Few prior studies have evaluated ED PCA and no systematic evaluation of time and resources exists. Methodology: An RCT will be performed at 3 clinical centers. 750 patients with acute pain warranting IV opioid administration will be randomized to receive usual opioid analgesia determined by the provider or PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes). Pain intensity will be measured by a numerical rating scale (NRS) recorded every half hour up to 2 hours after initial opioid administration. Primary endpoints are rate of change in pain intensity from 30 minutes after initial administration of opioid to 2 hours as suggested by the results of the preliminary study and incidence of adverse events. PCA will also be compared to non-PCA opioid analgesia assessed at the end of the 2 hour study period by patient satisfaction with pain management; registered nurse (RN) assessment of time efficiency/ease of use and satisfaction with pain management; and physician satisfaction with pain management. Resource utilization and cost associated with implementation and use of PCA in the ED setting will be assessed by total Registered nurse (RN) time spent on pain management per patient; pharmacy preparation time per patient; material cost per patient and

Registered Nurse and Physician training time necessary for PCA implementation. Significance:

If PCA is demonstrated to be effective, safe, and associated with patient and provider acceptance and acceptable resource utilization, it has the potential to significantly improve ED pain management.

Condition or Disease	Intervention/Treatment	Phase
Pain	Device: Patient controlled analgesia (PCA); Other: Usual Care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 636 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effectiveness and Feasibility of Patient Controlled Analgesia in the ED
• Actual Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient Controlled Analgesia PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes)	Device: Patient controlled analgesia (PCA); Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes
Active Comparator: Usual Care Usual opioid analgesia determined by the provider	Other: Usual Care; Usual opioid analgesia determined by the provider

Outcome Measures

Primary Outcome Measures

1. Rate of Change in Pain Intensity Per Hour [1.5 hours]

   Rate of Change in Numerical Rating Scale (NRS) of Pain per hour where 0 indicates "no pain", 10 indicates "worst possible pain" between 30 minutes and 120 minutes post-baseline i.e. NRS at 30 minutes minus NRS at 120 minutes post-baseline.

Secondary Outcome Measures

1. Number of Participants With One or More Adverse Events [2 hours]

   Number of participants with one or more adverse events defined by: oxygen saturation measured by pulse oximetry < 92% for one minute or more, respiratory rate <10 breaths/min counted for 60 seconds, or systolic blood pressure < 90 mm Hg.

2. Patient Satisfaction With Pain Management [2 hours]

   Self report of satisfaction with treatment at120 minutes after baseline

Other Outcome Measures

1. Nurse Preference for PCA or Conventional Administration of IV Opioids [2 hours]

   Single question about preference for PCA versus preference for conventional administration of IV opioids.

2. Physician Preference for PCA or Usual Care [2 hours]

   Single question about physician preference for PCA or conventional administration of IV opioids

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age 18 to 65

2. Patient deemed by the ED attending physician to require IV opioid analgesia for pain and for whom the ED Attending Physician would consider using PCA

Exclusion Criteria:

1. Patients requiring initial resuscitation that would preclude the use of PCA

2. Long-term use of prescription or non-prescription opioids now or within the past year

3. Recent opioid use within the past 24 hours

4. Chronic pain syndromes

5. Clinician suspicion of current or past opioid dependence/abuse

6. Altered mental status/Clinical suspicion of intoxication

7. Patients expected to require conscious sedation while in the ED

8. Pregnancy or breast-feeding

9. History of chronic obstructive pulmonary disease, history of sleep apnea syndrome, baseline oxygen saturation (room air) < 97%

10. Systolic blood pressure < 100 mm Hg

11. Use of sedative medications e.g. benzodiazepines, monoamine oxidase inhibitors, phenothiazines, or tricyclic antidepressants.

12. History of renal insufficiency/renal failure

13. Prior allergic reaction to morphine

14. Inability to provide informed consent or inability to understand or operate PCA device

15. Previous entry of patient into study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jacobi Medical Center	Bronx	New York	United States	10461
2	Montefiore Medical Center - Moses Division	Bronx	New York	United States	10467
3	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Albert Einstein College of Medicine
• Jacobi Medical Center
• Montefiore Medical Center
• University of Pennsylvania
• National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Polly Bijur, PhD, Albert Einstein College of Medicine
• Principal Investigator: Adrienne Birnbaum, MD, Jacobi Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Albert Einstein College of Medicine
• ClinicalTrials.gov Identifier: NCT01775371
• Other Study ID Numbers: 2012-485; R01NR013980
• First Posted: Jan 25, 2013
• Last Update Posted: Dec 4, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by Albert Einstein College of Medicine: Pain; Emergency; Analgesia; ED patients; acute pain; IV opioid

Study Results

Participant Flow

Recruitment Details	Recruitment occurred from April 30, 2013 through February 25, 2016 in the Emergency Departments of three medical centers.

Arm/Group Title	Patient Controlled Analgesia	Usual Care
Arm/Group Description	PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes) Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes	Usual opioid analgesia determined by the provider Usual Care: Usual opioid analgesia determined by the provider
Period Title: Overall Study
STARTED	306	330
COMPLETED	306	330
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Patient Controlled Analgesia	Usual Care	Total
Arm/Group Description	PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes) Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes	Usual opioid analgesia determined by the provider Usual Care: Usual opioid analgesia determined by the provider	Total of all reporting groups
Overall Participants	306	330	636
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	306 100%	330 100%	636 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	180 58.8%	202 61.2%	382 60.1%
Male	126 41.2%	128 38.8%	254 39.9%
Race/Ethnicity, Customized (Count of Participants)
Hispanic	179 58.5%	205 62.1%	384 60.4%
African-American	69 22.5%	80 24.2%	149 23.4%
White	22 7.2%	25 7.6%	47 7.4%
Other	36 11.8%	20 6.1%	56 8.8%
Region of Enrollment (participants) [Number]
United States	306 100%	330 100%	636 100%
Location of pain (Count of Participants)
Abdomen	239 78.1%	254 77%	493 77.5%
Other	67 21.9%	76 23%	143 22.5%
Initial Numerical Rating Scale (NRS) of pain intensity score (Count of Participants)
NRS Score 3-6	6 2%	19 5.8%	25 3.9%
NRS Score 7	29 9.5%	27 8.2%	56 8.8%
NRS Score 8	47 15.4%	59 17.9%	106 16.7%
NRS Score 9	57 18.6%	56 17%	113 17.8%
NRS Score 10	167 54.6%	169 51.2%	336 52.8%
Received non-opioid analgesics before arrival to Emergency Department (Count of Participants)
Yes	86 28.1%	105 31.8%	191 30%
No	220 71.9%	225 68.2%	445 70%

Outcome Measures

1. Primary Outcome

Title	Rate of Change in Pain Intensity Per Hour
Description	Rate of Change in Numerical Rating Scale (NRS) of Pain per hour where 0 indicates "no pain", 10 indicates "worst possible pain" between 30 minutes and 120 minutes post-baseline i.e. NRS at 30 minutes minus NRS at 120 minutes post-baseline.
Time Frame	1.5 hours

Outcome Measure Data

Analysis Population Description

All patients enrolled

Arm/Group Title	Patient Controlled Analgesia	Usual Care
Arm/Group Description	PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes) Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes	Usual opioid analgesia determined by the provider Usual Care: Usual opioid analgesia determined by the provider
Measure Participants	306	330
Mean (95% Confidence Interval) [Score on a scale per hour]	1.3	0.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient Controlled Analgesia, Usual Care
	Comments	The rate of change of NRS pain scores per hour was calculated using a mixed effects linear model. Time is represented as a linear spline with knot at 30 minutes to support the separate estimation of early and late phase rates of change. Fixed effects in the analysis includes study-group indicator, early and late phase time, and interactions between study-group and time. The principal hypothesis test was a z-test of the coefficient of the study group late phase interaction term.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The a priori threshold for statistical significance was 0.05.
	Method	Z-test 2-sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.6 to 1.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	The direction of the comparison is the Patient Controlled Analgesia minus the standard care group

2. Secondary Outcome

Title	Number of Participants With One or More Adverse Events
Description	Number of participants with one or more adverse events defined by: oxygen saturation measured by pulse oximetry < 92% for one minute or more, respiratory rate <10 breaths/min counted for 60 seconds, or systolic blood pressure < 90 mm Hg.
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

All patients

Arm/Group Title	Patient Controlled Analgesia	Usual Care
Arm/Group Description	PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes) Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes	Usual opioid analgesia determined by the provider Usual Care: Usual opioid analgesia determined by the provider
Measure Participants	306	330
One or more adverse events	7 2.3%	1 0.3%
No adverse events	299 97.7%	329 99.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient Controlled Analgesia, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.025
	Comments
	Method	Chi-squared
	Comments

3. Secondary Outcome

Title	Patient Satisfaction With Pain Management
Description	Self report of satisfaction with treatment at120 minutes after baseline
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

Patients with data at 120 minutes

Arm/Group Title	Patient Controlled Analgesia	Usual Care
Arm/Group Description	PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes) Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes	Usual opioid analgesia determined by the provider Usual Care: Usual opioid analgesia determined by the provider
Measure Participants	281	323
Satisfied	247 80.7%	254 77%
Dissatisfied or neutral	34 11.1%	69 20.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient Controlled Analgesia, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Chi-squared
	Comments

4. Other Pre-specified Outcome

Title	Nurse Preference for PCA or Conventional Administration of IV Opioids
Description	Single question about preference for PCA versus preference for conventional administration of IV opioids.
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

All Registered Nurses

Arm/Group Title	All Registered Nurses
Arm/Group Description	All Registered Nurses who treated one or more patients in the study
Measure Participants	198
Prefer Usual Care	102 33.3%
No preference	56 18.3%
Prefer PCA	40 13.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient Controlled Analgesia
	Comments	These outcomes are based on the nurses who took care of patients in the study
	Type of Statistical Test	Other
	Comments	Responses occur with equal probability
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments	One-sample chi-squared test of hypothesis that the responses occur with equal probability

5. Other Pre-specified Outcome

Title	Physician Preference for PCA or Usual Care
Description	Single question about physician preference for PCA or conventional administration of IV opioids
Time Frame	2 hours

Outcome Measure Data

Analysis Population Description

All Physicians who entered one or more patients in each arm of the study

Arm/Group Title	All Physicians
Arm/Group Description	All Physicians who entered one or more patients in each arm of the study
Measure Participants	143
Prefer Usual Care	25 8.2%
No Preference	49 16%
Prefer PCA	69 22.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patient Controlled Analgesia
	Comments	This outcome is based on the physicians who took care of the patients in the study
	Type of Statistical Test	Other
	Comments	All responses occur with equal probability
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments	One-sample chi-squared test of hypothesis that the responses occur with equal probability

Adverse Events

Time Frame	2 hours
Adverse Event Reporting Description	Need for oxygen supplementation or ventilatory assistance Hypotension requiring fluid administration or vasopressors Administration of naloxone (an opioid reversal agent) Oxygen saturation measured by pulse oximetry < 92% for one minute or more Respiratory rate <10 breaths/min counted for 60 seconds Systolic blood pressure < 90 mm Hg.
Arm/Group Title	Patient Controlled Analgesia		Usual Care
Arm/Group Description	PCA (loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes) Patient controlled analgesia (PCA): Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes		Usual opioid analgesia determined by the provider Usual Care: Usual opioid analgesia determined by the provider
All Cause Mortality
	Patient Controlled Analgesia		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/306 (0%)		0/331 (0%)
Serious Adverse Events
	Patient Controlled Analgesia		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/306 (0%)		0/330 (0%)
Other (Not Including Serious) Adverse Events
	Patient Controlled Analgesia		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/306 (2.3%)		1/330 (0.3%)
Cardiac disorders
Hypotension	4/306 (1.3%)		0/330 (0%)
Respiratory, thoracic and mediastinal disorders
Oxygen desaturation	3/306 (1%)		1/330 (0.3%)

Limitations/Caveats

The full benefit of PCA may accrue over a longer period of time than observed during two-hours. Two-hours not be long enough to capture the full benefit of access to re-dosing in response to the diminishing effect of initial analgesic dose over time.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.