Low Dose Ketamine (LDK) Versus Morphine for Acute Pain Control in the Emergency Department
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ClinicalTrials.gov Identifier: NCT01538745 |
Recruitment Status :
Completed
First Posted : February 24, 2012
Results First Posted : February 4, 2021
Last Update Posted : February 4, 2021
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Tracking Information | ||||
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First Submitted Date ICMJE | February 21, 2012 | |||
First Posted Date ICMJE | February 24, 2012 | |||
Results First Submitted Date ICMJE | July 17, 2013 | |||
Results First Posted Date ICMJE | February 4, 2021 | |||
Last Update Posted Date | February 4, 2021 | |||
Study Start Date ICMJE | February 2012 | |||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Maximal Change in Numerical Rating Scale (NRS) Pain Score From Baseline NRS Pain Score [ Time Frame: 5,10,20,40,60,80,100,120 minutes post dose ] Numerical Rating Scale (NRS) pain score is an 11-point rating scale for pain. With 0 being no pain and 10 being the worst pain imaginable.
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Original Primary Outcome Measures ICMJE |
Maximal change in NRS pain score as a percentage of initial NRS pain score [ Time Frame: 20,40,60,80,100,120 minutes post dose ] Evaluation of the maximal change in patient's pain (based on their numerical rating scale score) throughout the study versus their initial pain rating prior to drug administration.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Low Dose Ketamine (LDK) Versus Morphine for Acute Pain Control in the Emergency Department | |||
Official Title ICMJE | Low Dose Ketamine (LDK) Versus Morphine for Acute Pain Control in the Emergency Department | |||
Brief Summary | The purpose of this study is to compare the safety and effectiveness of intravenous low dose ketamine (LDK) to the industry standard of morphine (MOR) in regards to controlling acute pain in the emergency department. Both LDK and morphine have side effects. The amount and character of these side effects will be compared. Additionally, the degree of sedation or agitation will be specifically measured. The aim of this current study is to make this comparison and shift the evidence for LDK use from the anecdotal to the scientific. |
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Detailed Description | Phase 1 is a randomized, controlled, double-blinded study comparing the use of low-dose ketamine (LDK) to morphine for acute pain control in emergency department patients. A convenience sample of subjects will be enrolled from a population of patients aged 18-50 who present to the Brooke Army Medical Center Emergency Department with acute abdominal pain, flank/lumbar back pain and/or pain to the extremities. To take part in the study, a need for opioid analgesia must be indicated by the treating physician in addition to the patient meeting all other study criteria. The patient will then be randomized into one of the two treatment arms. Prior to receiving either the study medication (ketamine) or the active control (morphine) the patient will be asked to rate their pain on a numeric rating scale (NRS) with 0 being no pain and 10 being the worst pain possible. Their baseline vital signs (blood pressure, heart rate, respiratory rate and oxygen saturation) will also be documented. These vital signs and the NRS will be reassessed at 5, 10 and 20 minutes post medication dosage. At 20 minutes they will also document a Richmond Agitation Sedation Scale (RASS) score and will ask the patient if they require additional pain medication. If the patient denies the need for a second dose of medication they will continue to be re-assessed every 20 minutes (vital signs, NRS, and RASS) until either inpatient admission, discharge home, transfer to the operating room or until a total of 120 minutes after initial dosing. If at any time during the study the patient requires a second dose of pain medication, following the administration of the med, they will be assessed for vital signs at 5,10 and 20 minutes after the dose. At 20 minutes, a RASS score and NRS score will also be documented. They will then be re-assessed every 20 minutes (vital signs, NRS, and RASS) until either inpatient admission, discharge home, transfer to the operating room or until a total of 120 minutes after initial dosing. If they require a third dose of pain medication at any time during the study, this is considered a treatment failure and the treating physician will be contacted to provide any further pain control. The second phase of the study will be observational. An anonymous satisfaction survey will be provided to the treating nurse, physician or physicians assistant (PA) of the patients recruited from part one of the study. The purpose of conducting the survey is so that an observation point of view can be added to the data to provide a measure of how well the patient's pain was controlled. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
45 | |||
Original Estimated Enrollment ICMJE |
210 | |||
Actual Study Completion Date ICMJE | June 2013 | |||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 59 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
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Administrative Information | ||||
NCT Number ICMJE | NCT01538745 | |||
Other Study ID Numbers ICMJE | C.2011.173 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Joshua Miller, Brooke Army Medical Center | |||
Study Sponsor ICMJE | Brooke Army Medical Center | |||
Collaborators ICMJE | U.S. Air Force Office of the Surgeon General | |||
Investigators ICMJE |
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PRS Account | Brooke Army Medical Center | |||
Verification Date | February 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |