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

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.

Intervention / Treatment

  • Ketamine continuous infusion (DEVICE)
    Ketamine 0.1% 250mL continuous infusion (0,2ml/kg/h)
  • Placebo (DRUG)
    Placebo continuous infusion (0,2 ml/kg/h)

Condition or Disease

  • Pain, Burning

Phase

  • Phase 3
  • Study Design

    Study type: INTERVENTIONAL
    Status: Withdrawn
    Study results: No Results Available
    Age: 18 Years to 60 Years
    Enrollment: 0 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jan 01, 2018 ESTIMATED
    Primary Completion: Jan 01, 2019 ACTUAL
    Completion Date: May 01, 2020 ACTUAL
    Study First Posted: Aug 09, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: May 20, 2021

    Sponsors / Collaborators

    Responsible Party: N/A

    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.

    Participant Groups

    • Ketamine continuous infusion 0,2mg/kg/h

    • Placebo in continuous infusion

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 60
    Age Groups: Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes
    • Rescue analgesic demand will be evaluated through patient controlled analgesia device up to 10 days of intervention

    Secondary Outcomes
    • the research team using a side effects questionnaire based on the major ketamine and opioid side effects

    More Details

    NCT Number: NCT02860117
    Acronym: ccimb
    Other IDs: 1551628
    Study URL: https://clinicaltrials.gov/study/NCT02860117
    Last updated: Sep 29, 2023