Comparing Ketamine and Morphine in the Treatment of Acute Fracture Pain
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|ClinicalTrials.gov Identifier: NCT02430818|
Recruitment Status : Terminated (were not able to enroll patients to a satisfactory level)
First Posted : April 30, 2015
Results First Posted : May 22, 2019
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain Fractures||Drug: ketamine Drug: morphine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparing the Effectiveness of Low-dose Ketamine With Morphine to Treat Pain in Patients With Long Bone Fractures|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
Ketamine is a dissociative agent that is thought to modulate pain by binding to NMDA receptors. Participants assigned to the ketamine arm will be given 0.4 mg/kg IV of ketamine (40 mg maximum).
Morphine is an opioid that acts on opioidergic receptors to modulate pain. Participants in the opioid arm will receive 0.1 mg/kg IV of morphine (10 mg maximum).
- Pain Treatment-VAS (Visual Analog Scale) [ Time Frame: At 0 minutes and 60 minutes ]Study outcomes involve change in participants' pain as measured by a visual analog scale. The scale is a 10 inch line from 0 to 10 inches with 10 being the most pain and 0 being no pain. There are no units on the scale; it is just a straight line from no pain (0) to the worst pain (10). We assessed at o, 15, and 60 minutes but only scored the VAS at 60 minutes.
- Number of Participants With an Adverse Effects [ Time Frame: 60 minutes ]We will monitor for adverse effects and record for changes in vital signs including nausea and vomiting, hypotension, respiratory depression, laryngospasm, and emotional and psychological effects (emergence reactions).
- Would the Participant Would Consider Using the Drug Given to Them for Pain Relief in the Future [ Time Frame: 60 minutes ]Patients will be assessed to determine whether the participant would consider using the drug given to them for pain relief in the future. It was measured on a likert scale from 1-5 with 1 being did not like and would not use the drug again to 5 being like and would definitely receive the medication again. There are no units. The numbers below are the total number of patients that completed this answer. This was only asked on patients that received medication as if they did not receive medication the answer would not make sense. The median value is the likert value on a scale of 1-5 with the standard deviation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430818
|United States, Missouri|
|Barnes Jewish Hospital|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Nicholas Musisca, MD||Physician|