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

  • 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

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

Lead Sponsor: Universidad de Antioquia
Lead sponsor is responsible party
Responsible Party: N/A

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

Participant Groups

  • 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

Primary Outcomes
  • 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.

  • 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
  • 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.

  • 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.

  • 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