The Effect of Preprocedural Subanesthetic Ketamine on Pain and Anxiety

NCT ID: NCT06310850

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-01
• Study Completion Date: 2023-06-01

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.

Detailed Description

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.

Conditions

Epidural Catheterization; Thoracic; Procedural Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group Placebo

intravenous placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Group Ketamine

intravenous ketamine 0.15 mg kg-1

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: 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.

Interventions

Ketamine

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Ataturk Sanatorium Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Onur Kucuk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Onur KÜÇÜK, specialist

Role: PRINCIPAL_INVESTIGATOR

Ankara Ataturk Sanatorium Training and Research Hospital

Locations

Ankara Atatürk Sanatorium Training and Research Hospital

Ankara, Keçiören, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KEAH-238

Identifier Type: -

Identifier Source: org_study_id