Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00580489
Other study ID # IRB06-00065
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2006
Est. completion date December 2008

Study information

Verified date July 2022
Source MetroHealth Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Periodic reports are made to the IRB.


Recruitment information / eligibility

Status Completed
Enrollment 204
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 69 Years
Eligibility Inclusion Criteria: - Trauma patient - Able to speak/communicate a pain scale Exclusion Criteria: - Age <18 - Age >69 - Initially or any time hypotensive - Prisoner

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
either fentanyl or morphine
either morphine 4mg IV or fentanyl 50mcg IV

Locations

Country Name City State
United States MetroHealth Medical Center Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Recording of Instance of Narcotic Side Effects. Instances of narcotic side effects (vital sign derangement, itching, nausea/vomiting) . 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.
See also
  Status Clinical Trial Phase
Completed NCT02901561 - Comparison Between 2 Doses of Misoprostol Before Intrauterine Device Phase 2/Phase 3
Completed NCT02905058 - Efficacy of Ketoprofen Before Intrauterine Device Insertion Phase 3
Completed NCT02905045 - Efficacy of Ketoprofen Before Hysterosalpingography Phase 3
Recruiting NCT00773760 - MOR and COMT SNP Polymorphism and Pain N/A
Completed NCT03733015 - Daily Sessions of rTMS to the Left DLPFC Modulate the Pain Thresholds and CPM N/A
Completed NCT02943135 - Lidocaine In-situ Gel Before Intrauterine Device Insertion Phase 3
Completed NCT04473508 - Erectus Nerve Block for Lumbar Spine Surgery Phase 3
Completed NCT02969902 - Buzzy Distraction During Venipuncture N/A
Enrolling by invitation NCT03184649 - Ibuprofen, Paracetamol Versus Placebo on Pain During Local Anesthetic Injection (RCT) Phase 1/Phase 2
Completed NCT02614391 - Tablet Distraction for Pain Control During Venipuncture Phase 3
Recruiting NCT00768014 - fMRI Measurements on Pain Relief Methods in First Stage Labor Pain N/A
Completed NCT04586712 - Efficacy of a Controlled Short-term Trial of Cannabidiol (CBD) Ingestion on Reducing Symptomatic Response and Facilitating Recovery After Induced Muscle Injury Phase 2
Not yet recruiting NCT04781777 - Effect of Ultrasonographic Guided Insulin Injection With Dexamethasone and Local Anesthetic Mixture in Diabetic Patients With Mild to Moderate Carpal Tunnel . N/A
Recruiting NCT06456177 - Nociception Monitoring During Epidural Analgesia
Recruiting NCT00914498 - The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section N/A
Completed NCT00638274 - Comparison of Loss of Resistance Techniques Phase 2
Recruiting NCT04656821 - Erector Spinae Block Versus Thoracic Paravertebral Block for Acute Thoracic Herpes Zoster Phase 4
Withdrawn NCT01263652 - Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients N/A
Completed NCT01925469 - Benzocaine Versus Placebo Spray for Pain Relief at Hysterosalpingogram Phase 4
Completed NCT03263884 - Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain N/A