Ketamine Continuous Infusion on Opioid Consumption and Pain Management in Severe Burned Patients (ccimb)

The Effectiveness of Ketamine Continuous Infusion on Opioid Consumption and Pain Management in Severe Burned Patients, a Randomized, Double-blind, Placebo-controlled Study

The purpose of this study is to evaluate the efficacy of ketamine in continuous infusion in the control of pain intensity, the impact on the consumption of opioids and observe the side effect profile in patients suffering from great extent of burns.

Study Overview

• Status: Withdrawn
• Conditions: Pain, Burning
• Intervention / Treatment: Device: Ketamine continuous infusion; Drug: Placebo

Detailed Description

Despite advances in pharmacology and in analgesic techniques, pain in burned patients is unwieldy yet, this occurs in such cases due to the complexity and intensity and the need for multidisciplinary medical team. The burn pain is classified as nociceptive, but can also present a neuropathic component. Overall this is a pain at rest and during movement, being aggravated by procedures like changing dressings. In the weeks after the burn there is intense pain due to injury and the management of the framework, which often involves dressing changes and other procedures such as surgery in donor area skin.

The use of opioids in high doses can lead to unwanted side effects.To reduce the adverse effects resulting from the use of opioids in high doses, we purpose the use of intravenous continuous infusion of ketamine. In controlling the pain of major burned patient there is evidence only of the use of ketamine in the form of intermittent boluses, especially during dressing changes or in the perioperative period. The use of ketamine in continuous infusion lacks evidence in this group of patients The purpose of this study is to evaluate the efficacy of ketamine in continuous infusion in the control of pain intensity, the impact on the consumption of opioids and observe the side effect profile in patients suffering from great extent of burns.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403-000
      • Hospital das Clínicas da FMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria will be considered:

1. patients admitted to the burn unit of the Clinical Hospital with burnt body area of 25% or more;
2. aged between 18 and 60 years;
3. with surgical risk classification according to the "American Society of Anesthesiologists' (ASA) I and II;
4. has no known allergy or any other contraindications of the drugs that are used in the treatment protocol;
5. hemodynamically stable, considering systolic blood pressure greater than 90 mmHg;
6. with preserved consciousness level, measured by the Glasgow coma scale, with a score equal to 15;
7. with the possibility of drug administration orally or by naso-gastric tube

Exclusion criteria will be considered:

1. patients younger than 18 or older than 60 years;
2. with surgical risk classification according to the "American Society of Anesthesiologists' (ASA) III or higher;
3. with known allergy or any contraindications of the drugs that are used in the treatment protocol;
4. patients with q chronic pain or chronic analgesic users prior to burning in treatment;
5. hemodynamically unstable, considering systolic blood pressure below 90 mm Hg;
6. with changing level of consciousness;
7. without the possibility of administering drugs orally or by nasogastric tube.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ketatamine; Ketamine continuous infusion 0,2mg/kg/h	Device: Ketamine continuous infusion; Ketamine 0.1% 250mL continuous infusion (0,2ml/kg/h); Other Names: Ketamine
Placebo Comparator: Placebo; Placebo in continuous infusion	Drug: Placebo; Placebo continuous infusion (0,2 ml/kg/h); Other Names: NaCl 0,9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	Rescue analgesic demand will be evaluated through patient controlled analgesia device up to 10 days of intervention	up to 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects questionnaire	the research team using a side effects questionnaire based on the major ketamine and opioid side effects	up to 10 days

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Study Director: Claudia Palmeira, MD, PhD, University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: July 26, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 9, 2016

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: ketamine; continuous infusion; severe burned patients
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 1551628

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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