Pain
Conditions
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
Usual opioid analgesia determined by the provider
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Patient Satisfaction With Pain Management | 2 hours | Self report of satisfaction with treatment at120 minutes after baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Physician Preference for PCA or Usual Care | 2 hours | Single 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
| Arm | Count |
|---|---|
| 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 |
| Total | 636 |
Baseline characteristics
| Characteristic | Patient Controlled Analgesia | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 306 Participants | 330 Participants | 636 Participants |
| Initial Numerical Rating Scale (NRS) of pain intensity score NRS Score 10 | 167 Participants | 169 Participants | 336 Participants |
| Initial Numerical Rating Scale (NRS) of pain intensity score NRS Score 3-6 | 6 Participants | 19 Participants | 25 Participants |
| Initial Numerical Rating Scale (NRS) of pain intensity score NRS Score 7 | 29 Participants | 27 Participants | 56 Participants |
| Initial Numerical Rating Scale (NRS) of pain intensity score NRS Score 8 | 47 Participants | 59 Participants | 106 Participants |
| Initial Numerical Rating Scale (NRS) of pain intensity score NRS Score 9 | 57 Participants | 56 Participants | 113 Participants |
| Location of pain Abdomen | 239 Participants | 254 Participants | 493 Participants |
| Location of pain Other | 67 Participants | 76 Participants | 143 Participants |
| Race/Ethnicity, Customized African-American | 69 Participants | 80 Participants | 149 Participants |
| Race/Ethnicity, Customized Hispanic | 179 Participants | 205 Participants | 384 Participants |
| Race/Ethnicity, Customized Other | 36 Participants | 20 Participants | 56 Participants |
| Race/Ethnicity, Customized White | 22 Participants | 25 Participants | 47 Participants |
| Received non-opioid analgesics before arrival to Emergency Department No | 220 Participants | 225 Participants | 445 Participants |
| Received non-opioid analgesics before arrival to Emergency Department Yes | 86 Participants | 105 Participants | 191 Participants |
| Region of Enrollment United States | 306 participants | 330 participants | 636 participants |
| Sex: Female, Male Female | 180 Participants | 202 Participants | 382 Participants |
| Sex: Female, Male Male | 126 Participants | 128 Participants | 254 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 306 | 0 / 331 |
| other Total, other adverse events | 7 / 306 | 1 / 330 |
| serious Total, serious adverse events | 0 / 306 | 0 / 330 |
Outcome results
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Patient Controlled Analgesia | Rate of Change in Pain Intensity Per Hour | 1.3 Score on a scale per hour |
| Usual Care | Rate of Change in Pain Intensity Per Hour | 0.3 Score on a scale per hour |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Controlled Analgesia | Number of Participants With One or More Adverse Events | One or more adverse events | 7 Participants |
| Patient Controlled Analgesia | Number of Participants With One or More Adverse Events | No adverse events | 299 Participants |
| Usual Care | Number of Participants With One or More Adverse Events | One or more adverse events | 1 Participants |
| Usual Care | Number of Participants With One or More Adverse Events | No adverse events | 329 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Controlled Analgesia | Patient Satisfaction With Pain Management | Satisfied | 247 Participants |
| Patient Controlled Analgesia | Patient Satisfaction With Pain Management | Dissatisfied or neutral | 34 Participants |
| Usual Care | Patient Satisfaction With Pain Management | Satisfied | 254 Participants |
| Usual Care | Patient Satisfaction With Pain Management | Dissatisfied or neutral | 69 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Controlled Analgesia | Nurse Preference for PCA or Conventional Administration of IV Opioids | No preference | 56 Participants |
| Patient Controlled Analgesia | Nurse Preference for PCA or Conventional Administration of IV Opioids | Prefer Usual Care | 102 Participants |
| Patient Controlled Analgesia | Nurse Preference for PCA or Conventional Administration of IV Opioids | Prefer PCA | 40 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patient Controlled Analgesia | Physician Preference for PCA or Usual Care | Prefer Usual Care | 25 Participants |
| Patient Controlled Analgesia | Physician Preference for PCA or Usual Care | No Preference | 49 Participants |
| Patient Controlled Analgesia | Physician Preference for PCA or Usual Care | Prefer PCA | 69 Participants |