Cardiovascular Safety After Continuous Ketamine Infusion
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|ClinicalTrials.gov Identifier: NCT03979105|
Recruitment Status : Completed
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
|Condition or disease||Intervention/treatment|
|Pain Ketamine Adverse Reaction Postoperative Pain||Drug: Ketamine|
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.
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
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||Cardiovascular and Neuropsychiatric Side Effects in Ketamine Analgesic Infusions in Acute Pain|
|Actual Study Start Date :||July 1, 2017|
|Actual Primary Completion Date :||November 1, 2018|
|Actual Study Completion Date :||December 31, 2018|
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.
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
Other Name: Ketalar
- Tachycardia [ Time Frame: 2 days ]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.
- Hypertension [ Time Frame: 2 days ]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.
- Delirium [ Time Frame: 2 days ]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.
- Hallucinations [ Time Frame: 2 days ]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.
- Nightmares [ Time Frame: 2 days ]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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979105
|hospital universitario San Vicente Fundacion|
|Medellin, Antioquia, Colombia|
|Adriana Cadavid, MD|
|Medellín, Antiquia, Colombia, 050010|
|Principal Investigator:||Adriana M Cadavid, MD||Anesthesiology Investigator|