Total ventilator days
Evaluation of Ketamine and Multi-modal Analgesics
Brief 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.
Intervention / Treatment
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Ketamine (DRUG)Receive an analgesic regimen that involves Ketamine infusions
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Lidocaine (DRUG)Receive an analgesic regimen that involves Lidocaine infusions
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Acetaminophen (DRUG)May be administered Acetaminophen rectally, by mouth, or intravenously in patients not suitable for either of the other methods of administration
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Neurontin (DRUG)May be given Neurontin by mouth as an approved medication for pain control
Condition or Disease
- Pain
Phase
Study Design
| Study type: | OBSERVATIONAL |
|---|---|
| Status: | Withdrawn |
| Study results: | No Results Available |
| Age: | 18 Years to 85 Years |
| Enrollment: | 0 (ACTUAL) |
| Funded by: | Other |
| Time Perspective: | Prospective |
| Observational Model: | Cohort |
Masking |
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Clinical Trial Dates
| Start date: | Jul 01, 2016 | |
|---|---|---|
| Primary Completion: | Jan 01, 2018 | ESTIMATED |
| Completion Date: | Jul 01, 2018 | ESTIMATED |
| Study First Posted: | Jun 28, 2016 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jul 30, 2019 |
Sponsors / Collaborators
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.
Participant Groups
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Intensivists will proceed with analgesia utilizing conventional opioid based pain order sets.
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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.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 85 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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
Primary Outcomes
Secondary Outcomes
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ICU length of stay
More Details
| NCT Number: | NCT02815111 |
|---|---|
| Other IDs: | IRB201600316 |
| Study URL: | https://clinicaltrials.gov/study/NCT02815111 |
Last updated: Sep 29, 2023