Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

Pain Clinical Trial

Official title:

Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910208
• Other study ID #: 2008-448
• Secondary ID: 1R21NR010929-01
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Est. completion date: June 2010

Study information

• Verified date: December 2019
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Pain

Intervention

Device:
• Patient-controlled analgesia
Intravenous morphine delivered via Curlin painsmart PCA device

Drug:
• morphine
Intravenous morphine

Locations

Country	Name	City	State
United States	Jacobi Medical Center	Bronx	New York

Sponsors (4)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	Jacobi Medical Center, National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Long Term Efficacy: Pain Relief by 120 Minutes	Participants aksed to and give range	120 minutes
Primary	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	Need for Supplementary Analgesia	count of participants who needed or did not needed additional analgesia	2 hours post treatment