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Trial record 25 of 837 for:    Ketamine

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
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

Brief Summary:

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

Detailed Description:

The procedure:

  1. Eligible patients will be identified by the ED personnel.
  2. Research physician will address the patient, explain about the trial and ask the patient to sign a consent form.
  3. The patient will be randomized and assigned to a trial group: "A" or "B" and it will be noted in the Data sheet.
  4. According to physician order (IV amount and IM amount) and patient group assignment, the nurse will prepare and administer the different drugs.
  5. 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.
  6. 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.

  7. 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.
  8. 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.
  9. Measurement of vital signs will not interfere with any other treatment that the patients receives for their injury in the ED.
  10. 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.
  11. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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 ]



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-70
  • Self-report pain greater than or equal to 7/10 on a numerical-verbal scale
  • Weigh 50-100 kg
  • Have systolic blood pressure of 90-180 mmHg
  • Have an ASA (American Society of Anaesthesiologists' classification) score of 1-2

Exclusion Criteria:

  • Have had opioid analgesia administered within 6 hours of the study
  • Are chronic analgesia users (of opioid or others)
  • Have known allergies to morphine or ketamine
  • Are pregnant
  • Have a psychiatric history

Information from the National Library of Medicine

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


Contacts
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Contact: Daniel Trotzky, MD +97236973829 danieltro@tlvmc.gov.il
Contact: Omri Ritter, MD +972508683149 omrir@tlvmc.gov.il

Locations
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Israel
Tel Aviv Sourasky Medical Center, department of Emergency Medicine
Tel-Aviv, Israel, 6423906
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

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Responsible Party: michal roll, Director, R&D Department, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT04013958     History of Changes
Other Study ID Numbers: TASMC-19-DT-0060-19-CTIL
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: a table summering pain assessing questioners will be available from corresponding author on reasonable request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by michal roll, Tel-Aviv Sourasky Medical Center:
Morphine
Ketamine
Renal colic

Additional relevant MeSH terms:
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Ketamine
Acute Pain
Colic
Renal Colic
Pain
Neurologic Manifestations
Signs and Symptoms
Infant, Newborn, Diseases
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action