Pain, BurningPhase 3ccimbNCT02860117
Ketamine Continuous Infusion on Opioid Consumption and Pain Management in Severe Burned Patients
A Phase 3 study testing Ketamine continuous infusion in people with Pain, Burning, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain, Burning
- What is being tested?
- Ketamine continuous infusion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2018to 1 May 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Ketamine continuous infusion, Placebo
- Keywords
- ketamine, continuous infusion, severe burned patients
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine continuous infusionDevice
Also called Ketamine
Ketamine 0.1% 250mL continuous infusion (0,2ml/kg/h)
PlaceboDrug
Also called NaCl 0,9%
Placebo continuous infusion (0,2 ml/kg/h)
| Study group | Role | What they receive |
|---|---|---|
| Ketatamine | Active comparator | Ketamine continuous infusion 0,2mg/kg/h Receives: Device: Ketamine continuous infusion |
| Placebo | Placebo comparator | Placebo in continuous infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Rescue analgesic demand will be evaluated through patient controlled analgesia device up to 10 days of intervention
Measured: up to 10 days
Secondary outcomes (1)
Side effects questionnaire
the research team using a side effects questionnaire based on the major ketamine and opioid side effects
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startJan 2018 (estimated)
- Primary completion1 Jan 2019
- Study completion1 May 2020
Why it stopped: change in hospital policy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, BurningStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Chiodini Machado, University of Sao Paulo General Hospital
- Investigators
- Claudia Palmeira, MD, PhD, Study director, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860117
- Sponsor's protocol ID
- 1551628
- Acronym
- ccimb
- Status last verified
- May 2021
- First submitted
- 26 Jul 2016
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02860117
- Acronym / sponsor ID
- ccimb / 1551628
- Conditions
- Pain, Burning
- Keywords
- ketamine, continuous infusion, severe burned patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: change in hospital policy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketatamine | Active comparator | Device: Ketamine continuous infusionKetamine continuous infusion 0,2mg/kg/h |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo in continuous infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine continuous infusionAlso: KetamineKetamine 0.1% 250mL continuous infusion (0,2ml/kg/h) | Device | Ketatamine |
| PlaceboAlso: NaCl 0,9%Placebo continuous infusion (0,2 ml/kg/h) | Drug | Placebo |
Primary outcome
Opioid consumption
Time frame: up to 10 days
Rescue analgesic demand will be evaluated through patient controlled analgesia device up to 10 days of intervention
1 secondary outcome
Side effects questionnaire
Time frame: up to 10 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Individual participant dataSharing planned: No
Related trials for Pain, Burning
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
RecruitingPhase 2
Analgesic Efficacy and Safety of Topical VMD-3866 Gel in Management of Pain Induced by Chemotherapy (CIPN)
Chemotherapy-induced Peripheral Neuropathy, Chemotherapy-induced Neuropathic Pain
Not yet recruitingObservational study
Phoenixin and Pain in Pediatric Burn Patients
Children, Acute Pain
Active, not recruiting
Hologram Burn Dressing on Pain, Anxiety, Fear, Patient Satisfaction, and Physiological Parameters
Anxiety, Burn Pain
Recruiting
MucoLock™ for Treatment of Stomatitis
Stomatitis, Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Palmeira, MD, PhD study director
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine continuous infusion in people with Pain, Burning, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.