PainNCT02815111
Evaluation of Ketamine and Multi-modal Analgesics
An observational study of Pain, run by University of Florida.
Trial summary
The purpose of this research study is to see if pain can be better controlled with fewer side effects. The new drug regimen will study several different medicines that have different ways of treating pain. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain
- What is being tested?
- Ketamine, Lidocaine and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2018
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing planned surgery for cardiac problems
Who may be able to join
- American Society of Anesthesiologists (ASA) status 1-4
- Undergoing planned surgery for cardiac problems
- 18 years of age and not older than 85 years of age
Who cannot join
- Severe liver disease (alanine aminotransferase (ALT) , aspartate aminotransferase (AST), or bilirubin > 2.5 times Upper Limit of Normal)
- Pregnancy or currently breastfeeding
- History of schizophrenia or other hallucinatory psychiatric disorder
- History of chronic or pre-existing pain disorder
- History of heart block
- Severe renal impairment Creatinine Clearance (CrCl)<30 milliliter(mL)/min
About this study
Official title: Evaluation of Ketamine and Multi-modal Analgesics for Postoperative Analgesia, Opioid Sparing, and Early Extubation in ICU Compared With Conventional Analgesia
The purpose of this research study is to see if pain can be better controlled with fewer side effects. The new drug regimen will study several different medicines that have different ways of treating pain.
Read the detailed description
The investigators plan to study an analgesic regimen of Ketamine and Lidocaine as infusions with Neurontin and acetaminophen delivered orally for postoperative analgesia and the subsequent effect on ventilator days and ICU stay. The investigators expect that pain scores will be either unchanged or better than historic controls. In addition, the investigators expect that ventilator days and ICU stay will be improved due to reduced incidence of delirium and bowel dysfunction.
- Conditions
- Pain
- Being tested
- Ketamine, Lidocaine, Acetaminophen, Neurontin
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Receive an analgesic regimen that involves Ketamine infusions
LidocaineDrug
Also called Lidopen
Receive an analgesic regimen that involves Lidocaine infusions
AcetaminophenDrug
Also called Tylenol
May be administered Acetaminophen rectally, by mouth, or intravenously in patients not suitable for either of the other methods of administration
NeurontinDrug
Also called Gabapentin
May be given Neurontin by mouth as an approved medication for pain control
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Intensivists will proceed with analgesia utilizing conventional opioid based pain order sets. | |
| Study Group | The investigators plan to study an analgesic regimen of Ketamine and lidocaine as infusions with Neurontin and Acetaminophen delivered orally for postoperative analgesia and the subsequent effect on ventilator days and ICU stay. Receives: Drug: Ketamine; Drug: Lidocaine; Drug: Acetaminophen; Drug: Neurontin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes between the two groups assessed by overall ventilator days
Total ventilator days
Measured: Through study completion, an average of one week
Secondary outcomes (1)
Changes between the two groups assessed by ICU length of stay
ICU length of stay
Measured: Through study completion, an average of one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2018 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: Not IRB approved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean Kiley, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815111
- Sponsor's protocol ID
- IRB201600316
- Status last verified
- Jul 2019
- First submitted
- 16 Jun 2016
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ketamine and Multi-modal Analgesics for Postoperative Analgesia, Opioid Sparing, and Early Extubation in ICU Compared With Conventional Analgesia
- ClinicalTrials.gov ID
- NCT02815111
- Acronym / sponsor ID
- IRB201600316
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not IRB approved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 28 Jun 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 research study is to see if pain can be better controlled with fewer side effects. The new drug regimen will study several different medicines that have different ways of treating pain.
Detailed description
The investigators plan to study an analgesic regimen of Ketamine and Lidocaine as infusions with Neurontin and acetaminophen delivered orally for postoperative analgesia and the subsequent effect on ventilator days and ICU stay. The investigators expect that pain scores will be either unchanged or better than historic controls. In addition, the investigators expect that ventilator days and ICU stay will be improved due to reduced incidence of delirium and bowel dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Intensivists will proceed with analgesia utilizing conventional opioid based pain order sets. |
| Study Group | – | Drug: Ketamine, Drug: Lidocaine, Drug: Acetaminophen, Drug: NeurontinThe investigators plan to study an analgesic regimen of Ketamine and lidocaine as infusions with Neurontin and Acetaminophen delivered orally for postoperative analgesia and the subsequent effect on ventilator days and ICU stay. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing planned surgery for cardiac problems
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) status 1-4
- Undergoing planned surgery for cardiac problems
- 18 years of age and not older than 85 years of age
Key exclusion criteria (6 listed)
- Severe liver disease (alanine aminotransferase (ALT) , aspartate aminotransferase (AST), or bilirubin > 2.5 times Upper Limit of Normal)
- Pregnancy or currently breastfeeding
- History of schizophrenia or other hallucinatory psychiatric disorder
- History of chronic or pre-existing pain disorder
- History of heart block
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 |
|---|---|---|
| KetamineAlso: KetalarReceive an analgesic regimen that involves Ketamine infusions | Drug | Study Group |
| LidocaineAlso: LidopenReceive an analgesic regimen that involves Lidocaine infusions | Drug | Study Group |
| AcetaminophenAlso: TylenolMay be administered Acetaminophen rectally, by mouth, or intravenously in patients not suitable for either of the other methods of administration | Drug | Study Group |
| NeurontinAlso: GabapentinMay be given Neurontin by mouth as an approved medication for pain control | Drug | Study Group |
Primary outcome
Changes between the two groups assessed by overall ventilator days
Time frame: Through study completion, an average of one week
Total ventilator days
1 secondary outcome
Changes between the two groups assessed by ICU length of stay
Time frame: Through study completion, an average of one week
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 31 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Sean Kiley, M.D. principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by University of Florida.
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 3 inclusion and 6 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Changes between the two groups assessed by overall ventilator days (time frame: Through study completion, an average of one week). 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 31 Jul 2019.