The Effect of Preprocedural Subanesthetic Ketamine on Pain and Anxiety

NCT06310850 | Completed Phase 3

• 1 other identifier: KEAH-238
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epidural Catheterization; Thoracic; Procedural Pain

Keywords

ketamine; pain; anxiety; subanesthetic

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (VAS)

  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).

  1 day (5 times)

Study Arms (2)

Group Placebo

PLACEBO COMPARATOR

intravenous placebo

Other: Placebo

Group Ketamine

ACTIVE COMPARATOR

intravenous ketamine 0.15 mg kg-1

Drug: Ketamine

Interventions

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.

Group Ketamine

Placebo OTHER

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

Group Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Ataturk Sanatorium Training and Research Hospital: lead

Study Sites (1)

Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Keçiören, 06290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural; Pain; Anxiety Disorders

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Onur KÜÇÜK, specialist

  Ankara Ataturk Sanatorium Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study was designed as a randomized, prospective study

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 15, 2024
• Study Start: June 1, 2013
• Primary Completion: January 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)