Clinical trial NCT03979105: Cardiovascular Safety After Continuous Ketamine Infusion
Official title: Cardiovascular and Neuropsychiatric Side Effects in Ketamine Analgesic Infusions in Acute Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Ketamine Adverse Reaction
Postoperative Pain
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with acute pain after surgery or medical painful condition

Brief summary: Observational study that evaluate the cardiovascular and neuropsychiatric side effects of ketamine analgesic infusions for acute pain

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Tachycardia
timeFrame: 2 days
measure: Hypertension
timeFrame: 2 days
Secondary outcomes:
measure: Delirium
timeFrame: 2 days
measure: Hallucinations
timeFrame: 2 days
measure: Nightmares
timeFrame: 2 days
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: hospital universitario San Vicente Fundacion
state: Antioquia
city: Medellín
country: Colombia
facility: Adriana Cadavid, MD
state: Antiquia
Study officials:
affiliation: Anesthesiology Investigator
name: Adriana M Cadavid, MD
role: PRINCIPAL_INVESTIGATOR
References:
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