Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

NCT00910208 | Completed Results DMC

• 2 other identifiers: 2008-4481R21NR010929-01
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain; Analgesia; Analgesia, Patient-controlled; Emergency Medicine

Outcome Measures

Primary Outcomes (5)

• 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.

  Baseline and 30 minutes post treatment

• 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)

  30 minutes post treatment

• 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

  Baseline, 30, 60, 90, 120 post-treatment

• Long Term Efficacy: Pain Relief by 120 Minutes

  Participants aksed to and give range

  120 minutes

• Safety: Incidence of Adverse Events

  Adverse Events defined as: oxygen saturation \< 92%; respiratory rate \<10 breaths/min; systolic blood pressure \< 90 mm Hg)

  2 hours

Secondary Outcomes (1)

• Need for Supplementary Analgesia

  2 hours post treatment

Study Arms (3)

Patient-controlled analgesia 1 mg demand dose

EXPERIMENTAL

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

Device: Patient-controlled analgesia; Drug: morphine

Patient-controlled analgesia 1.5 mg demand dose

EXPERIMENTAL

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

Device: Patient-controlled analgesia; Drug: morphine

Non-Patient-controlled analgesia comparison group

ACTIVE COMPARATOR

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

Drug: morphine

Interventions

Patient-controlled analgesia DEVICE

Intravenous morphine delivered via Curlin painsmart PCA device

Also known as: PCA

Patient-controlled analgesia 1 mg demand dose; Patient-controlled analgesia 1.5 mg demand dose

morphine DRUG

Intravenous morphine

Non-Patient-controlled analgesia comparison group; Patient-controlled analgesia 1 mg demand dose; Patient-controlled analgesia 1.5 mg demand dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Nursing Research (NINR): collaborator
• Jacobi Medical Center: collaborator

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (1)

• 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.

  PMID: 22506940 DERIVED

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Analgesia, Patient-Controlled; Passive Cutaneous Anaphylaxis; Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Polly Bijur, PhD
• Organization: Albert Einstein College of Medicine

polly.bijur@einstein.yu.edu

718-430-4217

Study Officials

• Adrienne J Birnbaum, MD, MS

  Jacobi Medical Center, Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Polly E Bijur, PhD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2009
• First Posted: May 29, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: December 27, 2019
• Results First Posted: December 27, 2019

Record last verified: 2019-12

Locations

US (1)