Comparison of Treatment by IM Ketamine to IV Ketamine in Patients With Renal Colic
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|ClinicalTrials.gov Identifier: NCT04013958|
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Patients who present to the emergency department (ED), with acute pain due to renal colic, are often treated with opioids. Treatment with opioids has many disadvantages - cardio-respiratory depression, nausea, vomiting and long term dependence. For these reasons, there is a constant search for a way to reduce the use of opioids. ketamine has been proven to augmented the analgesic effect of opioids, and thus reduce the use and adverse effects of opioids. Different studies about the use of Ketamine as a sedition agent have shown that Ketamine given IM versus IV has longer duration of effect with less adverse effects.
The study we are conducting is designed to test and analyze the safety and efficacy of IV Ketamine with IV Morphine compared to IV Ketamine and morphine with IM placebo in a setting of acute pain due to, or suspected renal colic in the ED. When both ways of administration are given 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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain Renal Colic||Drug: IV Ketamine Drug: IM Ketamine||Phase 3|
- Eligible patients will be identified by the ED personnel.
- Research physician will address the patient, explain about the trial and ask the patient to sign a consent form.
- The patient will be randomized and assigned to a trial group: "A" or "B" and it will be noted in the Data sheet.
- According to physician order (IV amount and IM amount) and patient group assignment, the nurse will prepare and administer the different drugs.
- Patients in group "A" wiil receive IV Ketamine with IV morphine and IM placebo of normal saline. Patients in group "B" wiil receive IM Ketamine with IV morphine.
The amount will be calculated based on the patients' weight:
IV Morphine -0.1 mg/kg: Morphine vial contains 10 mg/10 ml. IV Ketamine -0.1 mg/kg: Ketamine vial contains 50 mg/1 ml. IM Ketamine -0.25 mg/kg: Ketamine vial contains 50 mg/1 ml.
- Prior to administering medication to the patient a research assistant, who is blinded to the choice of drugs given, will measure vital signs (blood pressure, heart rate and O2 saturation) as well as pain level on a 100 mm VAS (visual analogue scale) questionnaire.
- After administration of medications the researcher assistant will measure vital signs (blood pressure, heart rate and O2 saturation) as well as pain level on a 100 mm VAS questionnaire, at 5 and 10 minutes after administration, and then at 30, 45, 60, and 90 minutes.
- Measurement of vital signs will not interfere with any other treatment that the patients receives for their injury in the ED.
- Cardiorespiratory follow-up (as per bullet point number 8 above), will be concluded at 1.5 hours post-intervention, and clinical follow-up will continue as long as the patient remains in the ED.
- During the time of the the followup and after, if pain had not subsided sufficiently according to treating physician's clinical assessment, patient will receive further analgesic medications by physician order, as per ED protocol. The protocol takes into account concurrent medications.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Eligible patients will be randomized according to a blocked randomization scheme "WWW.RANDOMIZATION.COM" , which permits assignment of the participant to either group "A" or "group B" (the IM ketamine+IV morphine group or IV ketamine+IV morphine with IM saline (placebo) group.
Eligible patients will be divided in equal proportions (50 in group A and 50 in group B).
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Comparison of Treatment by IM Ketamine to IV Ketamine in Patients With Renal Colic|
|Estimated Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||August 1, 2021|
Active Comparator: IV Ketamine
IV Ketamine group will receive IV Ketamine with IV morphine and IM saline.
Drug: IV Ketamine
IV Ketamine 0.1 mg/kg with IV morphine -0.1 mg/kg with IM Sailne 0.9%
Other Name: No other
Experimental: IM Ketamine
IM Ketamine group will receive IM Ketamine with IV morphine.
Drug: IM Ketamine
IM Ketamine 0.3 mg/kg with IV morphine -0.1 mg/kg
- Effectiveness of IM Ketamine in decreasing pain intensity [patient assessed - VAS pain score] [ Time Frame: 1.5 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 1.5 hours follow-up.
- Adverse effects [Opiate Related Symptom Distress Scale] [ Time Frame: 1.5 hour post administration ]adverse effects [Opiate Related Symptom Distress Scale] [ Time Frame: 1.5 hour post administration ]
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): NCT04013958
|Contact: Daniel Trotzky, MDfirstname.lastname@example.org|
|Contact: Omri Ritter, MDemail@example.com|
|Tel Aviv Sourasky Medical Center, department of Emergency Medicine|
|Tel-Aviv, Israel, 6423906|