Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06310850
Study type Interventional
Source Ankara Ataturk Sanatorium Training and Research Hospital
Contact
Status Completed
Phase Phase 3
Start date June 1, 2013
Completion date June 1, 2023

See also
  Status Clinical Trial Phase
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Completed NCT00694174 - Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants Phase 4
Completed NCT06264960 - The Effect of Music Therapy and Breathing Exercise on Anxiety and Pain in Patients Undergoing Coronary Angiography N/A
Recruiting NCT06354608 - The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children N/A
Completed NCT05073497 - Efficacy of Finger Puppet as a Distraction Method N/A
Recruiting NCT05275881 - Impact of Virtual Reality in Pediatric Hematology and Oncology N/A
Completed NCT05656677 - Parental Involvement in Pain Reducing Measures N/A
Completed NCT04257019 - Pain, Anxiety During Interventional Spine Procedures N/A
Completed NCT05166551 - Effect of Acupressure on Interventional Pain in Infants N/A
Completed NCT04421430 - Nonpharmacological Methods for Children in Procedural Pain N/A
Completed NCT06380556 - The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates N/A
Not yet recruiting NCT05555498 - Virtual Reality for Anxiety and Pain Management During Oocyte Retrieval in IVF/ICSI Treatment N/A
Completed NCT03985930 - Non-immersive Virtual Reality for Pediatric Pain Management N/A
Completed NCT05179291 - Efficacy of VR and Buzzy on Pain and Anxiety N/A
Completed NCT05070325 - Nonpharmacological Methods for Children N/A
Completed NCT00150189 - Utilization of Oral Sucrose to Decrease Pain in Infants During Immunizations N/A
Completed NCT04254081 - Addition of Buprenorphine to Paracervical Block for Pain Control During Osmotic Dilator Insertion Phase 4
Recruiting NCT05895383 - Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy Phase 4
Not yet recruiting NCT06373627 - Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease N/A
Recruiting NCT04967118 - Neonatal Pain Management and Pain Monitoring Using New Methods N/A