Cardiovascular Safety After Continuous Ketamine Infusion

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979105
• Other study ID #: UdeA1005
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ketamine Adverse Reaction
• Pain
• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Colombia	hospital universitario San Vicente Fundacion	Medellin	Antioquia
Colombia	Adriana Cadavid, MD	Medellín	Antiquia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

References & Publications (7)

Assouline B, Tramèr MR, Kreienbühl 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Sigtermans MJ, van Hilten JJ, Bauer MC, Arbous MS, 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):304-11. doi: 10.1016/j.pain.2009.06.023. Epub 2009 Jul 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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