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Low-Dose Ketamine Infusion During Burn Wound Care

NCT ID: NCT06506565

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-08

Study Completion Date

2025-12-31

Brief Summary

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The current standard of care (SOC) (i.e. fentanyl and midazolam) offers limited efficacy for preventing or relieving pain. Ketamine infusions may provide the benefits of analgesia, minimize adverse events, and reduce opioid use. The purpose of this study is to determine if adding a low dose ketamine infusion during wound care will safely provide pain relief for patients with burn injury.

Detailed Description

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Conditions

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Burn Pain Dissociation Opioid

Keywords

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ketamine burn opioid analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomly enrolled by blocks according to age, burn size, and opioid use history. Study treatment will occur for up to 7 days. Assignment will be to placebo or ketamine and all participants and staff will be blinded, except pharmacy. Each patient will receive standard of care fentanyl and midazolam during wound care regardless of study assignment.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
All team members and patients are blinded to study treatment, except pharmacy staff.

Study Groups

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Ketamine

Ketamine infusion (0.3 mg/kg/hr) to begin 1 hour before wound care, continuing through and for 1 hour following wound care.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Infusion during wound care

Placebo

0.9% saline to begin 1 hour before wound care, continuing through and for 1 hour following wound care.

Group Type PLACEBO_COMPARATOR

0.9% NaCl

Intervention Type DRUG

Infusion during wound care

Interventions

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Ketamine

Infusion during wound care

Intervention Type DRUG

0.9% NaCl

Infusion during wound care

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

* Admitted to burn service with thermal injury

Exclusion Criteria

* unable/unwilling to consent within 72 hours
* unable to report NRS
* known contraindication to ketamine
* \< than 18 years of age
* pregnant
* incarcerated
* TBSA over 50 %
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Regional One Health

Memphis, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David M Hill, Pharm.D.

Role: CONTACT

Phone: 1-901-545-7100

Email: [email protected]

Facility Contacts

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Yvonne Shaw, RN

Role: primary

Other Identifiers

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23-09751-FB

Identifier Type: -

Identifier Source: org_study_id