Trial intelligence / Profile preview

Ketamine Continuous Infusion for Pain in Severe Burn Patients

NCT02860117Phase 3

Key facts

Status
Withdrawn
Start
Jan 2018
Primary completion
Jan 2019
Countries
1
Sponsor
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Modality
Small Molecules
01

Overview

Phase 3, randomised, double-blind trial comparing Ketamine with Placebo (2 arms). Primary endpoint: Opioid consumption at 10 days. Planned start Jan 2018; status: withdrawn.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Ketamine

    Ketamine continuous infusion 0.2mg/kg/h

  • Placebo

    Placebo continuous infusion

03

Who it enrols

Adult patients (18-60 years) with burns covering >= 25% of body area, ASA I-II, hemodynamically stable, and GCS 15. Excludes patients with chronic pain, chronic analgesic use, or ASA III+.

04

Endpoints

Primary

  • Opioid consumption

Secondary

  • Side effects questionnaire

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