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

Primary Purpose

Pain, Burning

Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Ketamine continuous infusion
Placebo
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Burning focused on measuring ketamine, continuous infusion, severe burned patients

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital das Clínicas da FMUSP

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ketatamine

Placebo

Arm Description

Ketamine continuous infusion 0,2mg/kg/h

Placebo in continuous infusion

Outcomes

Primary Outcome Measures

Opioid consumption
Rescue analgesic demand will be evaluated through patient controlled analgesia device up to 10 days of intervention

Secondary Outcome Measures

Side effects questionnaire
the research team using a side effects questionnaire based on the major ketamine and opioid side effects

Full Information

First Posted
July 26, 2016
Last Updated
May 20, 2021
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02860117
Brief Title
Ketamine Continuous Infusion on Opioid Consumption and Pain Management in Severe Burned Patients
Acronym
ccimb
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 Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
change in hospital policy
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Burning
Keywords
ketamine, continuous infusion, severe burned patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketatamine
Arm Type
Active Comparator
Arm Description
Ketamine continuous infusion 0,2mg/kg/h
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo in continuous infusion
Intervention Type
Device
Intervention Name(s)
Ketamine continuous infusion
Other Intervention Name(s)
Ketamine
Intervention Description
Ketamine 0.1% 250mL continuous infusion (0,2ml/kg/h)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
NaCl 0,9%
Intervention Description
Placebo continuous infusion (0,2 ml/kg/h)
Primary Outcome Measure Information:
Title
Opioid consumption
Description
Rescue analgesic demand will be evaluated through patient controlled analgesia device up to 10 days of intervention
Time Frame
up to 10 days
Secondary Outcome Measure Information:
Title
Side effects questionnaire
Description
the research team using a side effects questionnaire based on the major ketamine and opioid side effects
Time Frame
up to 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria will be considered: patients admitted to the burn unit of the Clinical Hospital with burnt body area of 25% or more; aged between 18 and 60 years; with surgical risk classification according to the "American Society of Anesthesiologists' (ASA) I and II; has no known allergy or any other contraindications of the drugs that are used in the treatment protocol; hemodynamically stable, considering systolic blood pressure greater than 90 mmHg; with preserved consciousness level, measured by the Glasgow coma scale, with a score equal to 15; with the possibility of drug administration orally or by naso-gastric tube Exclusion criteria will be considered: patients younger than 18 or older than 60 years; with surgical risk classification according to the "American Society of Anesthesiologists' (ASA) III or higher; with known allergy or any contraindications of the drugs that are used in the treatment protocol; patients with q chronic pain or chronic analgesic users prior to burning in treatment; hemodynamically unstable, considering systolic blood pressure below 90 mm Hg; with changing level of consciousness; without the possibility of administering drugs orally or by nasogastric tube.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Palmeira, MD, PhD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hospital das Clínicas da FMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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