NCT00580489

Brief Summary

The study is exempt from informed consent by the MetroHealth Medical Center institutional review board (IRB), because two standards of care are used and there is no increased clinical risk to the patient due to the study. The researchers randomize either fentanyl or morphine to be given to trauma patients and record how their pain scale is treated along with observing for adverse events. They are looking to see if the hypothesized benefits of fentanyl (which is much more expensive than morphine) actually exist.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
13.7 years until next milestone

Results Posted

Study results publicly available

August 16, 2022

Completed
Last Updated

August 16, 2022

Status Verified

July 1, 2022

Enrollment Period

2.3 years

First QC Date

December 21, 2007

Results QC Date

August 28, 2017

Last Update Submit

July 18, 2022

Conditions

Pain ReliefAdverse Events

Keywords

helicopteraeromedicalpain reliefanalgesiafentanylmorphineadverse events

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Numeric Pain Score (NPS) From First to Last Dose

    Mean difference in the numeric pain score (NPS) from the first dose to the final dose of medication administered. A significant mean pain score change is defined as greater than or equal to 2 Numeric Pain Score (NPS) 0-10, 0 Least pain, 10 most pain

    Medication was administered over a mean transport time of 37 minutes in the Morphine group and 43 minutes in the Fentanyl group.

Secondary Outcomes (1)

  • Recording of Instance of Narcotic Side Effects.

    Groups were observed a mean of 37 minutes in the Morphine Group and a mean of 43 minutes in the Fentanyl group for side effects.

Study Arms (2)

Arm C Morphine

ACTIVE COMPARATOR

Morphine given to trauma patients transported by helicopter

Drug: either fentanyl or morphine

Arm D Fentanyl

ACTIVE COMPARATOR

Fentanyl given to trauma patients transported by helicopter

Drug: either fentanyl or morphine

Interventions

either fentanyl or morphineDRUG

either morphine 4mg IV or fentanyl 50mcg IV

Arm C MorphineArm D Fentanyl

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Trauma patient
  • Able to speak/communicate a pain scale

You may not qualify if:

  • Age \<18
  • Age \>69
  • Initially or any time hypotensive
  • Prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (1)

  • Smith MD, Wang Y, Cudnik M, Smith DA, Pakiela J, Emerman CL. The effectiveness and adverse events of morphine versus fentanyl on a physician-staffed helicopter. J Emerg Med. 2012 Jul;43(1):69-75. doi: 10.1016/j.jemermed.2011.05.018.

    PMID: 21689900RESULT

MeSH Terms

Conditions

Agnosia

Interventions

Morphine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Limitations and Caveats

Power of study may be too low to determine small differences

Results Point of Contact

Title
Charles Emerman
Organization
Metrohealth Medical Center
cemerman@metrohealth.org
2167783577

Study Officials

  • Michael D Smith, MD

    MetroHealth Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Emergency Medicine, Case Western Reserve SOM

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 24, 2007

Study Start

August 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 16, 2022

Results First Posted

August 16, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)