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

NCT02860117 | Withdrawn Phase 3 DMC

• 1 other identifier: 1551628
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Burning

Keywords

ketamine; continuous infusion; severe burned patients

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  Rescue analgesic demand will be evaluated through patient controlled analgesia device up to 10 days of intervention

  up to 10 days

Secondary Outcomes (1)

• Side effects questionnaire

  up to 10 days

Study Arms (2)

Ketatamine

ACTIVE COMPARATOR

Ketamine continuous infusion 0,2mg/kg/h

Device: Ketamine continuous infusion

Placebo

PLACEBO COMPARATOR

Placebo in continuous infusion

Drug: Placebo

Interventions

Ketamine continuous infusion DEVICE

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

Also known as: Ketamine

Ketatamine

Placebo DRUG

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

Also known as: NaCl 0,9%

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients admitted to the burn unit of the Clinical Hospital with burnt body area of 25% or more;
• aged between 18 and 60 years;
• with surgical risk classification according to the "American Society of Anesthesiologists' (ASA) I and II;
• has no known allergy or any other contraindications of the drugs that are used in the treatment protocol;
• hemodynamically stable, considering systolic blood pressure greater than 90 mmHg;
• with preserved consciousness level, measured by the Glasgow coma scale, with a score equal to 15;
• with the possibility of drug administration orally or by naso-gastric tube

You may not qualify if:

• patients younger than 18 or older than 60 years;
• with surgical risk classification according to the "American Society of Anesthesiologists' (ASA) III or higher;
• with known allergy or any contraindications of the drugs that are used in the treatment protocol;
• patients with q chronic pain or chronic analgesic users prior to burning in treatment;
• hemodynamically unstable, considering systolic blood pressure below 90 mm Hg;
• with changing level of consciousness;
• without the possibility of administering drugs orally or by nasogastric tube.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas da FMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia Palmeira, MD, PhD

  University of Sao Paulo General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Member of USaoPauloGH Pain Management staff, Principal investigator

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 9, 2016
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: May 1, 2020
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)