Skip to main content
OpenTrials
Completed

NCT Number: NCT06310850

The Effect of Preprocedural Subanesthetic Ketamine on Pain and Anxiety

The thoracic epidural catheterization (TEC) can be both uncomfortable and fearful for patients when done awake with the thought that the procedure may be painful. The aim of this study was to assess the effect of subanesthetic intravenous ketamine administration on pain and anxiety during the TEC procedure.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Keçiören, 06290, Turkey (Türkiye)

About this study

The study aimed to assess the impact of subanesthetic intravenous ketamine administration on pain and anxiety during Thoracic Epidural Catheterisation (TEC) procedure, which can be uncomfortable and frightening for patients when performed awake due to the possibility of pain.

After receiving approval from the clinical research ethics committee of Keçiören Education and Research Hospital (KEAH; ID:238), this prospective and randomized study will include 60 adult patients with ASA physical status I-III who are scheduled for elective thoracic surgery via thoracotomy. The study will randomly assign patients into two groups: Group P (n=30) receiving an intravenous placebo and Group K (n=30) receiving intravenous (IV) 0.15 mg kg-1 ketamine. Randomisation will be performed using a computerised table of random numbers.

Patients with chronic pain, bleeding disorders, drug use, liver disease, severe metabolic and endocrine problems, a history of ketamine or local anaesthetic allergy, infection at the site of intervention, or refusal of TEC will be excluded. Patients who report acute pain during preoperative evaluation, have a TEC time of more than five minutes (from needle insertion to catheter insertion), and require more than two Tuohy needle attempts will be excluded. Vital parameters and anxiety levels of each patient will be recorded before premedication. Anxiety (VAS-A) and pain (VAS-P) scores will be measured using the visual analogue scale. Patients will be transported to the operating theatre 20 minutes after premedication. Intravenous administration of 0.15 mg/kg IV ketamine or placebo will take place 3 minutes before TEC placement.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who underwent elective thoracic surgery via thoracotomy
  • Patients with ASA physical status I-III

Exclusion criteria

  • Describing chronic pain,
  • Have a bleeding disorder,
  • Having a history of analgesia drug use,
  • Have a history of liver disease,
  • Have serious metabolic and endocrine problems,
  • Have a history of allergy to ketamine and local anesthetics,
  • Have an infection in the intervention area,
  • Rejecting thoracic epidural catheter,
  • Describing acute pain in any part of the body during the preoperative evaluation,
  • Thoracic epidural catheter duration greater than five minutes (time from needle entry to catheter placement)
  • Patients requiring more than two Tuohy injection attempts

Treatment and study plan

ketamine

Drug

Patients will be administered 0.15 mg kg-1 intravenous ketamine (The sample provided contains equal proportions of two enantiomers, S and R ketamine hydrochloride.) 3 minutes before thoracic epidural catheter placement.

Placebo

Other

Intravenous saline will be administered to patients 3 minutes before the thoracic epidural catheter is placed.

Primary outcomes

  1. Visual analog scale (VAS)

    Time frame: 1 day (5 times)

    For anxiety, on a 100 mm scale, 0 mm was defined as no anxiety, whereas 100 mm was as unbearable anxiety (VAS-A). A similar scoring method was used to assess pain intensity. 0 mm was defined as no pain and 100 mm as unbearable pain (VAS-P).

Sponsors and collaborators

Lead sponsor

Ankara Ataturk Sanatorium Training and Research Hospital

Other Gov

Registry information

Official study title

The Effect of Preprocedural Subanesthetic Ketamine for Pain and Anxiety in Patients During Thoracic Epidural Catheterization: A Randomized Trial

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2024
Registry last updated
Mar 15, 2024

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.

Published trials that share one or more normalized conditions with this study.