Ketamine and Morphine Versus Morphine Alone for the Treatment of Acute Pain in the Emergency Department

Study Overview
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Brief Summary
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Our goal is to study whether giving people low dose ketamine along with morphine when they come to the Emergency Department will help their pain more than giving morphine by itself. There have been many studies showing that low dose ketamine is safe and effective for pain control. Ketamine is frequently used for pain control in ambulances and helicopters transporting injured patients to the hospital and has also been used for pain control in people who have just had surgery. The investigators would like to see if low dose ketamine would be safe and effective for patients with pain in the Emergency Department. Patients are eligible for the study if they come to the Emergency Department and their treating physician decides to treat them with morphine (with certain exceptions such as pregnant patients and patients with eye injuries). They will be given information about participating in the study and if they agree, they will be given the study drug. The study drug will be either ketamine or salt water (saline). If patients continue to be in pain they will continue to receive doses of morphine just as they would if they were not in the study. If the treating physician feels that morphine alone is not enough, they will be free to choose another pain medication as they would normally.

Official Title
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Ketamine and Morphine Versus Morphine Alone for the Treatment of Acute Pain in the Emergency Department

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: Ketamine
* Drug: Morphine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presenting to Emergency Department in acute pain age 18 and over determined to require morphine for pain control by treating physician Exclusion Criteria: Patients presenting with headache or head injury Patient with eye injury or eye pain Nontraumatic chest Pain Pregnant patients or women of childbearing potential Patients allergic to morphine or ketamine Patients with known history of narcotic/alcohol abuse or presenting for narcotic medication refill Patients with hypertension: diastolic blood pressure > 100 OR systolic blood pressure > 180 Patient whose pain is so severe that they are unable to give informed consent Patients who have had bad experiences to prior hallucinations from any origin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Morphine and placebo<br>Patient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy | Drug: Morphine<br>* Dosage of morphine determined by treating physician<br>Drug: placebo<br>* saline of same volume as appropriate weight based dose of ketamine<br>|
| Experimental: Morphine and Ketamine<br>Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care | Drug: Ketamine<br>* 0.3mg/kg ketamine<br>Drug: Morphine<br>* Dosage of morphine determined by treating physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Score | Pain 0-10 with 0 being no pain and 10 being the worst pain | Baseline (zero minutes), 30 minutes and 1 hour after receiving study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Amount of Morphine and Other Pain Medications Administered |  | Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours) | 
| Number of Participants With Adverse Events |  | Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Acute Pain