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

• Status: Withdrawn
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo General Hospital
• Treatments: Ketamine

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.