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Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department

NCT ID: NCT00910208

Last Updated: 2019-12-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Pain

Keywords

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Pain Analgesia Analgesia, Patient-controlled Emergency Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patient-controlled analgesia 1 mg demand dose

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

Group Type EXPERIMENTAL

Patient-controlled analgesia

Intervention Type DEVICE

Intravenous morphine delivered via Curlin painsmart PCA device

morphine

Intervention Type DRUG

Intravenous morphine

Patient-controlled analgesia 1.5 mg demand dose

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

Group Type EXPERIMENTAL

Patient-controlled analgesia

Intervention Type DEVICE

Intravenous morphine delivered via Curlin painsmart PCA device

morphine

Intervention Type DRUG

Intravenous morphine

Non-Patient-controlled analgesia comparison group

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

Group Type ACTIVE_COMPARATOR

morphine

Intervention Type DRUG

Intravenous morphine

Interventions

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Patient-controlled analgesia

Intravenous morphine delivered via Curlin painsmart PCA device

Intervention Type DEVICE

morphine

Intravenous morphine

Intervention Type DRUG

Other Intervention Names

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PCA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Jacobi Medical Center

OTHER

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrienne J Birnbaum, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Jacobi Medical Center, Albert Einstein College of Medicine

Polly E Bijur, PhD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

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Jacobi Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22506940 (View on PubMed)

Other Identifiers

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1R21NR010929-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2008-448

Identifier Type: -

Identifier Source: org_study_id