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NCT04013958

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

Status unknown Phase 3 Last updated 10 July 2019
What this trial tests

Phase 3 trial testing IV Ketamine in Acute Pain in 100 participants. Status unknown.

Timeline
1 August 2019
Primary endpoint
1 August 2021
1 August 2021

Quick facts

Lead sponsorTel-Aviv Sourasky Medical Center
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposesupportive care
Enrollment100
Start date1 August 2019
Primary completion1 August 2021
Estimated completion1 August 2021
Sites1 location across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Tel-Aviv Sourasky Medical Center

Who can join

Adults 18 to 70, any sex, with Acute Pain or Renal Colic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of IV Ketamine

Trials testing the same drug.

Other recruiting trials for Acute Pain

Currently open trials in the same condition.

Other Tel-Aviv Sourasky Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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