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

Pain, Burning Clinical Trial

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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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02860117
• Other study ID #: 1551628
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: May 2021
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Pain, Burning

Intervention

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

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

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da FMUSP	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	Rescue analgesic demand will be evaluated through patient controlled analgesia device up to 10 days of intervention	up to 10 days
Secondary	Side effects questionnaire	the research team using a side effects questionnaire based on the major ketamine and opioid side effects	up to 10 days