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Comparison of Treatment by IM Ketamine to IV Ketamine in Patients With Renal Colic

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ClinicalTrials.gov Identifier: NCT04013958
Recruitment Status : Unknown
Verified July 2019 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE July 7, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date July 10, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2019)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Treatment by IM Ketamine to IV Ketamine in Patients With Renal Colic
Official Title  ICMJE Comparison of Treatment by IM Ketamine to IV Ketamine in Patients With Renal Colic
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Acute Pain
  • Renal Colic
Intervention  ICMJE
  • 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
  • Drug: IM Ketamine
    IM Ketamine 0.3 mg/kg with IV morphine -0.1 mg/kg
Study Arms  ICMJE
  • Active Comparator: IV Ketamine
    IV Ketamine group will receive IV Ketamine with IV morphine and IM saline.
    Intervention: Drug: IV Ketamine
  • Experimental: IM Ketamine
    IM Ketamine group will receive IM Ketamine with IV morphine.
    Intervention: Drug: IM Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 7, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04013958
Other Study ID Numbers  ICMJE TASMC-19-DT-0060-19-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Responsible Party michal roll, Tel-Aviv Sourasky Medical Center
Study Sponsor  ICMJE Tel-Aviv Sourasky Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP