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

NCT04013958 | Unknown Phase 3

• 1 other identifier: TASMC-19-DT-0060-19-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain; Renal Colic

Keywords

Morphine; Ketamine; Renal colic

Outcome Measures

Primary Outcomes (2)

• Effectiveness of IM Ketamine in decreasing pain intensity [patient assessed - VAS pain score]

  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.

  1.5 hour post administration

• Adverse effects [Opiate Related Symptom Distress Scale]

  adverse effects \[Opiate Related Symptom Distress Scale\] \[ Time Frame: 1.5 hour post administration \]

  1.5 hour post administration

Study Arms (2)

IV Ketamine

ACTIVE COMPARATOR

IV Ketamine group will receive IV Ketamine with IV morphine and IM saline.

Drug: IV Ketamine

IM Ketamine

EXPERIMENTAL

IM Ketamine group will receive IM Ketamine with IV morphine.

Drug: IM Ketamine

Interventions

IV Ketamine DRUG

IV Ketamine 0.1 mg/kg with IV morphine -0.1 mg/kg with IM Sailne 0.9%

Also known as: No other

IV Ketamine

IM Ketamine DRUG

IM Ketamine 0.3 mg/kg with IV morphine -0.1 mg/kg

IM Ketamine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center, department of Emergency Medicine

Tel Aviv, 6423906, Israel

Location

MeSH Terms

Conditions

Acute Pain; Renal Colic

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Daniel Trotzky, MD

CONTACT

+97236973829; danieltro@tlvmc.gov.il

Omri Ritter, MD

CONTACT

+972508683149; omrir@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, R&D Department

Model Details: 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).

Study Record Dates

• First Submitted: July 7, 2019
• First Posted: July 10, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IL (1)