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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Recruitment Status : Withdrawn (change in hospital policy)
First Posted : August 9, 2016
Last Update Posted : May 25, 2021
Sponsor:
Information provided by (Responsible Party):
Felipe Chiodini Machado, University of Sao Paulo General Hospital

Tracking Information
First Submitted Date  ICMJE July 26, 2016
First Posted Date  ICMJE August 9, 2016
Last Update Posted Date May 25, 2021
Estimated Study Start Date  ICMJE January 2018
Actual Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Continuous Infusion on Opioid Consumption and Pain Management in Severe Burned Patients
Official Title  ICMJE The Effectiveness of Ketamine Continuous Infusion on Opioid Consumption and Pain Management in Severe Burned Patients, a Randomized, Double-blind, Placebo-controlled Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain, Burning
Intervention  ICMJE
  • Device: Ketamine continuous infusion
    Ketamine 0.1% 250mL continuous infusion (0,2ml/kg/h)
    Other Name: Ketamine
  • Drug: Placebo
    Placebo continuous infusion (0,2 ml/kg/h)
    Other Name: NaCl 0,9%
Study Arms  ICMJE
  • Active Comparator: Ketatamine
    Ketamine continuous infusion 0,2mg/kg/h
    Intervention: Device: Ketamine continuous infusion
  • Placebo Comparator: Placebo
    Placebo in continuous infusion
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 20, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2016)
50
Actual Study Completion Date  ICMJE May 1, 2020
Actual Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02860117
Other Study ID Numbers  ICMJE 1551628
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Felipe Chiodini Machado, University of Sao Paulo General Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Sao Paulo General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Claudia Palmeira, MD, PhD University of Sao Paulo General Hospital
PRS Account University of Sao Paulo General Hospital
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP