NCT02860117

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

The Effectiveness of Ketamine Continuous Infusion on Opioid Consumption and Pain Management in Severe Burned Patients, a Randomized, Double-blind, Placebo-controlled Study

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Ketamine continuous infusion	Ketamine 0.1% 250mL continuous infusion (0,2ml/kg/h)
DRUG	Placebo	Placebo continuous infusion (0,2 ml/kg/h)

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-01-01
• Completion: 2020-05-01
• First posted: 2016-08-09
• Last updated: 2021-05-25

Locations

1 site across 1 country: Brazil