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Completed

NCT Number: NCT03979105

Cardiovascular Safety After Continuous Ketamine Infusion

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

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Key information

Conditions

Pain Ketamine Adverse Reaction Neurologic Manifestations Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

hospital universitario San Vicente Fundacion, Medellín, Antioquia, Colombia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Ketalar

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Registry information

Official study title

Cardiovascular and Neuropsychiatric Side Effects in Ketamine Analgesic Infusions in Acute Pain

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 7, 2019
Registry last updated
Jun 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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