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Effectiveness and Feasibility of Patient Controlled Analgesia in the ED

Effectiveness and Feasibility of Patient Controlled Analgesia in the ED

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01775371
Enrollment
636
Registered
2013-01-25
Start date
2013-04-30
Completion date
2016-02-29
Last updated
2020-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Pain, Emergency, Analgesia, ED patients, acute pain, IV opioid

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.

Interventions

Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes

OTHERUsual Care

Usual opioid analgesia determined by the provider

Sponsors

Jacobi Medical Center
CollaboratorOTHER
Montefiore Medical Center
CollaboratorOTHER
University of Pennsylvania
CollaboratorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH
Albert Einstein College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Change in Pain Intensity Per Hour1.5 hoursRate 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

MeasureTime frameDescription
Number of Participants With One or More Adverse Events2 hoursNumber 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.
Patient Satisfaction With Pain Management2 hoursSelf report of satisfaction with treatment at120 minutes after baseline

Other

MeasureTime frameDescription
Nurse Preference for PCA or Conventional Administration of IV Opioids2 hoursSingle question about preference for PCA versus preference for conventional administration of IV opioids.
Physician Preference for PCA or Usual Care2 hoursSingle question about physician preference for PCA or conventional administration of IV opioids

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

ArmCount
Patient Controlled Analgesia
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
306
Usual Care
Usual opioid analgesia determined by the provider Usual Care: Usual opioid analgesia determined by the provider
330
Total636

Baseline characteristics

CharacteristicPatient Controlled AnalgesiaUsual CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
306 Participants330 Participants636 Participants
Initial Numerical Rating Scale (NRS) of pain intensity score
NRS Score 10
167 Participants169 Participants336 Participants
Initial Numerical Rating Scale (NRS) of pain intensity score
NRS Score 3-6
6 Participants19 Participants25 Participants
Initial Numerical Rating Scale (NRS) of pain intensity score
NRS Score 7
29 Participants27 Participants56 Participants
Initial Numerical Rating Scale (NRS) of pain intensity score
NRS Score 8
47 Participants59 Participants106 Participants
Initial Numerical Rating Scale (NRS) of pain intensity score
NRS Score 9
57 Participants56 Participants113 Participants
Location of pain
Abdomen
239 Participants254 Participants493 Participants
Location of pain
Other
67 Participants76 Participants143 Participants
Race/Ethnicity, Customized
African-American
69 Participants80 Participants149 Participants
Race/Ethnicity, Customized
Hispanic
179 Participants205 Participants384 Participants
Race/Ethnicity, Customized
Other
36 Participants20 Participants56 Participants
Race/Ethnicity, Customized
White
22 Participants25 Participants47 Participants
Received non-opioid analgesics before arrival to Emergency Department
No
220 Participants225 Participants445 Participants
Received non-opioid analgesics before arrival to Emergency Department
Yes
86 Participants105 Participants191 Participants
Region of Enrollment
United States
306 participants330 participants636 participants
Sex: Female, Male
Female
180 Participants202 Participants382 Participants
Sex: Female, Male
Male
126 Participants128 Participants254 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 3060 / 331
other
Total, other adverse events
7 / 3061 / 330
serious
Total, serious adverse events
0 / 3060 / 330

Outcome results

Primary

Rate of Change in Pain Intensity Per Hour

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

Population: All patients enrolled

ArmMeasureValue (MEAN)
Patient Controlled AnalgesiaRate of Change in Pain Intensity Per Hour1.3 Score on a scale per hour
Usual CareRate of Change in Pain Intensity Per Hour0.3 Score on a scale per hour
Comparison: 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.p-value: <0.00195% CI: [0.6, 1.5]Z-test 2-sided
Secondary

Number of Participants With One or More Adverse Events

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

Population: All patients

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Patient Controlled AnalgesiaNumber of Participants With One or More Adverse EventsOne or more adverse events7 Participants
Patient Controlled AnalgesiaNumber of Participants With One or More Adverse EventsNo adverse events299 Participants
Usual CareNumber of Participants With One or More Adverse EventsOne or more adverse events1 Participants
Usual CareNumber of Participants With One or More Adverse EventsNo adverse events329 Participants
p-value: 0.025Chi-squared
Secondary

Patient Satisfaction With Pain Management

Self report of satisfaction with treatment at120 minutes after baseline

Time frame: 2 hours

Population: Patients with data at 120 minutes

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Patient Controlled AnalgesiaPatient Satisfaction With Pain ManagementSatisfied247 Participants
Patient Controlled AnalgesiaPatient Satisfaction With Pain ManagementDissatisfied or neutral34 Participants
Usual CarePatient Satisfaction With Pain ManagementSatisfied254 Participants
Usual CarePatient Satisfaction With Pain ManagementDissatisfied or neutral69 Participants
p-value: 0.003Chi-squared
Other Pre-specified

Nurse Preference for PCA or Conventional Administration of IV Opioids

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

Time frame: 2 hours

Population: All Registered Nurses

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Patient Controlled AnalgesiaNurse Preference for PCA or Conventional Administration of IV OpioidsNo preference56 Participants
Patient Controlled AnalgesiaNurse Preference for PCA or Conventional Administration of IV OpioidsPrefer Usual Care102 Participants
Patient Controlled AnalgesiaNurse Preference for PCA or Conventional Administration of IV OpioidsPrefer PCA40 Participants
Comparison: These outcomes are based on the nurses who took care of patients in the studyp-value: <0.001Chi-squared
Other Pre-specified

Physician Preference for PCA or Usual Care

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

Time frame: 2 hours

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Patient Controlled AnalgesiaPhysician Preference for PCA or Usual CarePrefer Usual Care25 Participants
Patient Controlled AnalgesiaPhysician Preference for PCA or Usual CareNo Preference49 Participants
Patient Controlled AnalgesiaPhysician Preference for PCA or Usual CarePrefer PCA69 Participants
Comparison: This outcome is based on the physicians who took care of the patients in the studyp-value: <0.001Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026