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

NCT ID: NCT02860117

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2020-05-01

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.

Conditions

Pain, Burning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ketatamine

Ketamine continuous infusion 0,2mg/kg/h

Group Type: ACTIVE_COMPARATOR

Ketamine continuous infusion

Intervention Type: DEVICE

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

Placebo

Placebo in continuous infusion

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo continuous infusion (0,2 ml/kg/h)

Interventions

Ketamine continuous infusion

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

Intervention Type: DEVICE

Placebo

Placebo continuous infusion (0,2 ml/kg/h)

Intervention Type: DRUG

Other Intervention Names

Ketamine; NaCl 0,9%

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Felipe Chiodini Machado

Anesthesiologist, Member of USaoPauloGH Pain Management staff, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Palmeira, MD, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo General Hospital

Locations

Hospital das Clínicas da FMUSP

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

1551628

Identifier Type: -

Identifier Source: org_study_id