Cardiovascular Safety After Continuous Ketamine Infusion

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

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

Study Overview

• Status: Completed
• Conditions: Pain; Postoperative Pain; Ketamine Adverse Reaction
• Intervention / Treatment: Drug: Ketamine

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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Hospital Universitario San Vicente Fundación
  • Antiquia
    • Medellín, Antiquia, Colombia, 050010
      • Adriana Cadavid, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with acute pain after surgery or medical painful condition

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ketamine infusion; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tachycardia	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 days
Hypertension	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.	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium	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 days
Hallucinations	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.	2 days
Nightmares	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.	2 days

Collaborators and Investigators

• Sponsor: Universidad de Antioquia
• Investigators: Principal Investigator: Adriana M Cadavid, MD, Anesthesiology Investigator

Publications and helpful links

General Publications

• Sigtermans MJ, van Hilten JJ, Bauer MCR, Arbous SM, Marinus J, Sarton EY, Dahan A. Ketamine produces effective and long-term pain relief in patients with Complex Regional Pain Syndrome Type 1. Pain. 2009 Oct;145(3):304-311. doi: 10.1016/j.pain.2009.06.023. Epub 2009 Jul 14.
• Avidan MS, Fritz BA, Maybrier HR, Muench MR, Escallier KE, Chen Y, Ben Abdallah A, Veselis RA, Hudetz JA, Pagel PS, Noh G, Pryor K, Kaiser H, Arya VK, Pong R, Jacobsohn E, Grocott HP, Choi S, Downey RJ, Inouye SK, Mashour GA. The Prevention of Delirium and Complications Associated with Surgical Treatments (PODCAST) study: protocol for an international multicentre randomised controlled trial. BMJ Open. 2014 Sep 17;4(9):e005651. doi: 10.1136/bmjopen-2014-005651.
• Kase D, Imoto K. The Role of HCN Channels on Membrane Excitability in the Nervous System. J Signal Transduct. 2012;2012:619747. doi: 10.1155/2012/619747. Epub 2012 Aug 13.
• Pomeroy JL, Marmura MJ, Nahas SJ, Viscusi ER. Ketamine Infusions for Treatment Refractory Headache. Headache. 2017 Feb;57(2):276-282. doi: 10.1111/head.13013. Epub 2016 Dec 27.
• Radvansky BM, Shah K, Parikh A, Sifonios AN, Le V, Eloy JD. Role of ketamine in acute postoperative pain management: a narrative review. Biomed Res Int. 2015;2015:749837. doi: 10.1155/2015/749837. Epub 2015 Oct 1.
• Garg N, Panda NB, Gandhi KA, Bhagat H, Batra YK, Grover VK, Chhabra R. Comparison of Small Dose Ketamine and Dexmedetomidine Infusion for Postoperative Analgesia in Spine Surgery--A Prospective Randomized Double-blind Placebo Controlled Study. J Neurosurg Anesthesiol. 2016 Jan;28(1):27-31. doi: 10.1097/ANA.0000000000000193.
• Assouline B, Tramer MR, Kreienbuhl L, Elia N. Benefit and harm of adding ketamine to an opioid in a patient-controlled analgesia device for the control of postoperative pain: systematic review and meta-analyses of randomized controlled trials with trial sequential analyses. Pain. 2016 Dec;157(12):2854-2864. doi: 10.1097/j.pain.0000000000000705.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: UdeA1005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No