Clinical trial NCT04013958: Comparison of Treatment by IM Ketamine to IV Ketamine in Patients With Renal Colic
Official title: Comparison of Treatment by IM Ketamine to IV Ketamine in Patients With Renal Colic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Pain
Renal Colic
Keywords: Morphine
Ketamine
Renal colic
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-07-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Effectiveness of IM Ketamine in decreasing pain intensity [patient assessed - VAS pain score]
timeFrame: 1.5 hour post administration
measure: Adverse effects [Opiate Related Symptom Distress Scale]
timeFrame: 1.5 hour post administration
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center, department of Emergency Medicine
Study officials:
References: