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

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ClinicalTrials.gov Identifier: NCT02860117
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Felipe Chiodini Machado, University of Sao Paulo General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain, Burning Drug: Ketamine continuous infusion Drug: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Ketamine Continuous Infusion on Opioid Consumption and Pain Management in Severe Burned Patients, a Randomized, Double-blind, Placebo-controlled Study
Study Start Date : May 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Ketatamine
Ketamine continuous infusion 0,2mg/kg/h
Drug: Ketamine continuous infusion
Ketamine 0.1% 250mL continuous infusion (0,2ml/kg/h)
Other Name: Ketamine

Placebo Comparator: Placebo
Placebo in continuous infusion
Drug: Placebo
Placebo continuous infusion (0,2 ml/kg/h)
Other Name: NaCl 0,9%




Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: up to 10 days ]
    Rescue analgesic demand will be evaluated through patient controlled analgesia device up to 10 days of intervention


Secondary Outcome Measures :
  1. Side effects questionnaire [ Time Frame: up to 10 days ]
    the research team using a side effects questionnaire based on the major ketamine and opioid side effects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860117


Contacts
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Contact: Felipe Machado, MD +551126616787 felipe.chiodini@hotmail.com

Locations
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Brazil
Hospital das Clínicas da FMUSP Recruiting
Sao Paulo, SP, Brazil, 05403-000
Contact: Felipe Machado, MD    +551126617947    felipe.chiodini@hotmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Study Director: Claudia Palmeira, MD, PhD University of Sao Paulo General Hospital

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Responsible Party: Felipe Chiodini Machado, Anesthesiologist, Member of USaoPauloGH Pain Management staff, Principal investigator, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02860117     History of Changes
Other Study ID Numbers: 1551628
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Felipe Chiodini Machado, University of Sao Paulo General Hospital:
ketamine
continuous infusion
severe burned patients

Additional relevant MeSH terms:
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Ketamine
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action