Clinical trial NCT00910208: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain
Analgesia
Analgesia, Patient-controlled
Emergency Medicine
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
name: Jacobi Medical Center
First posted: 2009-05-29
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale
timeFrame: Baseline and 30 minutes post treatment
measure: Participants With Short Term Efficacy: Pain Relief by 30 Minutes
timeFrame: 30 minutes post treatment
measure: Long Term Efficacy: Total Analgesia Provided Over 2 Hours
timeFrame: Baseline, 30, 60, 90, 120 post-treatment
measure: Long Term Efficacy: Pain Relief by 120 Minutes
timeFrame: 120 minutes
measure: Safety: Incidence of Adverse Events
timeFrame: 2 hours
Secondary outcomes:
measure: Need for Supplementary Analgesia
timeFrame: 2 hours post treatment
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
Study officials:
affiliation: Jacobi Medical Center, Albert Einstein College of Medicine
name: Adrienne J Birnbaum, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein College of Medicine
name: Polly E Bijur, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.