Cardiovascular Safety After Continuous Ketamine Infusion

Completed

• Conditions: Pain; Ketamine Adverse Reaction; Postoperative Pain
• Interventions: Drug: Ketamine

• Registration Number: NCT03979105
• Lead Sponsor: Universidad de Antioquia

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

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2018-11-01
• Study Completion: 2018-12-31
• Status Verified: 2019-04
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-06-06
• Last Update Submitted: 2019-06-06
• Study First Posted: 2019-06-07
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ketamine infusion	Ketamine	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.

Primary Outcome Measures

Name	Time	Method
Tachycardia	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	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 Outcome Measures

Name	Time	Method
Hallucinations	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.
Delirium	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.
Nightmares	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.

Trial Locations

Locations (2)

Adriana Cadavid, MD; 🇨🇴 Medellín, Antiquia, Colombia

hospital universitario San Vicente Fundacion; 🇨🇴 Medellin, Antioquia, Colombia