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

Phase 3

Withdrawn

• Conditions: Pain, Burning
• Interventions: Device: Ketamine continuous infusion; Drug: Placebo

• Registration Number: NCT02860117
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-09
• Study Start: 2018-01
• Primary Completion: 2019-01-01
• Study Completion: 2020-05-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketatamine	Ketamine continuous infusion	Ketamine continuous infusion 0,2mg/kg/h
Placebo	Placebo	Placebo in continuous infusion

Primary Outcome Measures

Name	Time	Method
Opioid consumption	up to 10 days	Rescue analgesic demand will be evaluated through patient controlled analgesia device up to 10 days of intervention

Secondary Outcome Measures

Name	Time	Method
Side effects questionnaire	up to 10 days	the research team using a side effects questionnaire based on the major ketamine and opioid side effects

Trial Locations

Locations (1)

Hospital das Clínicas da FMUSP; 🇧🇷 Sao Paulo, SP, Brazil