Presence of absence of tachycardia (100 or above beats for minute) as physiological parameter recorded with cardioscope in the first 48 hours in clinical chart database after the infusion of ketamine has started.
Cardiovascular Safety After Continuous Ketamine Infusion
Brief Summary
Observational study that evaluate the cardiovascular and neuropsychiatric side effects of ketamine analgesic infusions for acute pain
Intervention / Treatment
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Ketamine (DRUG)Drug: Ketamine Side effects associated with ketamine infusion to treat acute pain, were reviewed after 48 hours of exposure and frequency of tachycardia, hypertension, hallucinations, delirium and nightmares were registrated for comparison
Condition or Disease
- Pain
- Ketamine Adverse Reaction
- Postoperative Pain
Phase
Study Design
| Study type: | OBSERVATIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 300 (ACTUAL) |
| Funded by: | Other |
| Time Perspective: | Retrospective |
| Observational Model: | Cohort |
Masking |
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Clinical Trial Dates
| Start date: | Jul 01, 2017 | ACTUAL |
|---|---|---|
| Primary Completion: | Nov 01, 2018 | ACTUAL |
| Completion Date: | Dec 31, 2018 | ACTUAL |
| Study First Posted: | Jun 07, 2019 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jun 06, 2019 |
Sponsors / Collaborators
Location
Severe acute pain and opioid tolerance is an important symptom in patients after surgery.
Ketamine in analgesic infusion has been described to decrease acute pain, in patients with opioid tolerance. Ketamine use has been associated with side effects, which are doses dependant. Those side effects are mainly cardiovascular: Hypertension, tachycardia, and neuropsychiatric: delirium, hallucinations,nightmares that potentially compromise recovery of patients.
Objective:
To determine retrospectively in data bases the frequency of tachycardia, hypertension, delirium, hallucinations and nightmares, in adult patients that received ketamine infusions before and after administration of this drug in the first 48 hours to treat acute and postoperative pain
Ketamine in analgesic infusion has been described to decrease acute pain, in patients with opioid tolerance. Ketamine use has been associated with side effects, which are doses dependant. Those side effects are mainly cardiovascular: Hypertension, tachycardia, and neuropsychiatric: delirium, hallucinations,nightmares that potentially compromise recovery of patients.
Objective:
To determine retrospectively in data bases the frequency of tachycardia, hypertension, delirium, hallucinations and nightmares, in adult patients that received ketamine infusions before and after administration of this drug in the first 48 hours to treat acute and postoperative pain
Participant Groups
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Ketamine infusion treatment for acute pain in adult population in all type of surgery that received adjuvant analgesia with ketamine 0.1mg/kg/h during 48 hours.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* Patients older than 18 years old
* Acute and Postoperative pain
* Ketamine infusion at 0.15 mg/kg/h or below
Exclusion Criteria:
* Cognitive disfunction psychiatric illness
* Acute cardiovascular disease
* Anemia with Hb less than 7 g/dl
* Decompensated hyperthyroidism
* Low cardiac output
* Incomplete medical history
* Patients older than 18 years old
* Acute and Postoperative pain
* Ketamine infusion at 0.15 mg/kg/h or below
Exclusion Criteria:
* Cognitive disfunction psychiatric illness
* Acute cardiovascular disease
* Anemia with Hb less than 7 g/dl
* Decompensated hyperthyroidism
* Low cardiac output
* Incomplete medical history
Primary Outcomes
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Presence or absence of hypertension (140/90 mm Hg or above ) as physiological parameter recorded with electronic arm manometer in the first 48 hours in clinical chart database after the infusion of ketamine has started.
Secondary Outcomes
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Presence of absence of delirium reported in clinical records electronic database by nurse or physician in the first 48 hours after the infusion of ketamine has started.
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Presence of absence hallucinations reported in clinical electronic database records by nurse or physician in the first 48 hours after the infusion of ketamine has started.
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Presence of absence of nightmares reported in clinical electronic database records by nurse or physician, in the first 48 hours after the infusion of ketamine has started.
More Details
| NCT Number: | NCT03979105 |
|---|---|
| Other IDs: | UdeA1005 |
| Study URL: | https://clinicaltrials.gov/study/NCT03979105 |
Last updated: Sep 29, 2023