Ketamine For Acute Treatment of Pain in Emergency Department (KETAFAP)
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|ClinicalTrials.gov Identifier: NCT02306759|
Recruitment Status : Completed
First Posted : December 3, 2014
Results First Posted : June 1, 2017
Last Update Posted : August 9, 2017
The aim of the study is to compare the safety & efficacy of low dose ketamine and morphine versus morphine alone for acute generalized pain in the Emergency Department (ED). The investigators are also interested to investigate whether low-dose ketamine is a safe and effective alternative option to opioids for the acute treatment of pain in the Emergency Department.
The agents that are available in the department includes acetaminophen, non-steroidal anti-inflammatory (NSAIDS) and opioids. In most cases, acetaminophen and NSAIDS are not adequate to manage acute pain crisis. There is also heightening concerns for increased opioid use or abuse by patients. Since the HCAPHS survey includes various questions which inquires about patient perception of pain management in the department, the investigators are interested in investigating the safety and efficacy of low-dose ketamine to as an alternative method to opioids for the acute management of pain. There has been limited, mostly observational pilot studies, published in the literature. Limited data in the literature have reported the incidence of nausea and vomiting ranged from 3-13%. All published literature administered low-dose ketamine as an intravenous push. To the best of our knowledge our study would be the first study to administer low-dose ketamine as a short bolus infusion to mitigate the incidence of nausea and vomiting. The investigators believe our study would provide important scientific data to fill the theoretical gap that low-dose ketamine at 0.3mg/kg/dose may be a safe and effective agent for acute pain management in an ED that is located in the center of a densely populated urban area.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Ketamine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Ketamine For Acute Treatment of Pain in Emergency Department|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes
Placebo Comparator: Placebo
Normal saline 50ml intravenous piggyback (IVPB) over 15 minutes Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals
Normal saline 50ml, administered over 15 minutes
- Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes [ Time Frame: 15 minutes after administration of study intervention ]Change from Baseline of Pain as described by Numeric Rating Scale (NRS) [minimum:0, maximum 10] at 15 minutes. Lower values indicate worst outcomes while higher values indicate better outcomes.
- Number of Participants With Adverse Events [ Time Frame: during the study period ]Incidence or number of participants with adverse events.
- Patient Satisfaction of Pain Control Based on a Likert Scale [ Time Frame: At the end of study period ]Patient satisfaction of pain control based on a Likert Scale at the end of study completion, an average of 90 minutes. Scores reported out of scale of 10, 10 being most satisfied and 1 being least satisfied.
- Mean Consumption of Rescue Analgesia [ Time Frame: at designated intervals during study period (0, 15, 30, 45, 60, 75, 90, 105, 120 minutes) ]
- ED Length of Stay (Minutes) [ Time Frame: throughout study completion ]ED Length of stay (minutes) throughout study period
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): NCT02306759
|United States, New York|
|The Brooklyn Hospital Center|
|Brooklyn, New York, United States, 11201|
|Principal Investigator:||Billy Sin, Pharm.D.||The Brooklyn Hospital Center|