Clinical trial NCT02860117: Ketamine Continuous Infusion on Opioid Consumption and Pain Management in Severe Burned Patients
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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pain, Burning
Keywords: ketamine
continuous infusion
severe burned patients
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Opioid consumption
timeFrame: up to 10 days
Secondary outcomes:
measure: Side effects questionnaire
timeFrame: up to 10 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas da FMUSP
state: SP
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Claudia Palmeira, MD, PhD
role: STUDY_DIRECTOR
References: