A Phase 3 interventional study of Morphine and Ketamine in Acute Traumatic Pain, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-06-25.
Sponsored by Tel-Aviv Sourasky Medical Center · Phase 3, Interventional, and Other
Patients who present with acute traumatic injuries in the pre-hospital setting or to the emergency department (ED) are treated with opioids, the current gold standard for severe acute pain therapy. Treatment with opioids has many disadvantages: the need of skilled manpower to administer the medication IV, numerous side effects- mainly cardiorespiratory depression- which necessitates post medication administration continuous monitoring of patients. IV administration may be difficult or impossible to provide in a number of extreme circumstances. For these reasons, there is a constant search for alternate treatment options for pain in acute traumatic injuries. IN ketamine has only recently been studied favorably in our department in adults, in an open, prospective study (Shimonovich at al 2016), and warrants further investigation in the setting of acute traumatic pain. Ketamine is a safe and efficacious analgesic and is overall well received both by patients and physicians. Side effects include: hallucinations and dissociation. As opposed to opioids, ketamine does not alter patients' respiratory and hemodynamic stability giving ketamine great therapeutic potential for pain reduction in trauma patients, pre-hospital patients, and battlefield injuries. The study we are conducting is designed to test and analyze the safety and efficacy of IN Ketamine compared to IV morphine in a setting of acute traumatic pain in the ED, when both medications are administered by the protocol as is customary for treatment of pain in the Emergency Medicine department, and will be a prospective, randomized, double blind, controlled study.
The procedure:
The amount in the syringes will be calculated based on the patients' weight:
IV-0.1 mg/kg: Morphine vial contains 10 mg/10 ml = 1mg/ml ----> 0.1 ml/kg IN-1 mg/kg: Ketamine vial contains 100 mg/2 ml = 50mg/ml ---> 0.02ml/kg
After administration of medications the researcher will measure vital signs (blood pressure, heart rate, respiratory rate, and O2 saturation) as well as pain level on a 100 mm VAS questionnaire every 5 minutes for the first 30 minutes and then every 15 minutes after that at 30, 45, 60, and 90 minutes.
Saturation >95% on room air; if lower than 90%, the patient will be placed on 40% oxygen mask.
Tel-Aviv Sourasky Medical Center is the lead sponsor of 553 studies on the registry; 50 are open to participants now.
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Morphine group will receive IV medication and IN saline.
Drug: Morphine
Ketamine group will receive IV saline and IN medication.
Drug: Ketamine
Effectiveness of intranasal ketamine in decreasing pain intensity [patient assessed - VAS pain score] [ Time Frame: 2 hour post administration
Time to achieve a clinically meaningful pain reduction was defined as the first time-point at which the patient reported 15mm of pain reduction or more. Maximal pain reduction was defined as the lowest VAS score reported by the patient over the course of follow-up. Time to maximal pain reduction was defined as the time at which the patient has the lowest VAS score over the course of the 2 hours follow-up.
Time frame: 2 hours
• adverse effects [Opiate Related Symptom Distress Scale] [ Time Frame: 2 hour post administration ]
Adverse effects were recorded at the end of two hours using the 'Opiate Related Symptom Distress Scale' and included measurements of the presence, frequency, intensity and disruptiveness of 12 common opiate side-effects. Among these were nausea, vomiting, urinary retention, constipation, difficulty concentrating, dizziness, confusion, and others.
Time frame: 2 hours
• patient satisfaction [Interview] [ Time Frame: 2 hours post administration ]
patients were asked to provide subjective comments
Time frame: 2 hours post administration
Plan to share: Yes — a table summering pain assessing questioners will be available from corresponding author on reasonable request.
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
Start is estimated for Dec 2019; primary completion for Dec 2021, 24 months later.
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This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ketamine
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