The Effect of Preprocedural Subanesthetic Ketamine on Pain & Anxiety

Status Completed

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

Clinical Trial Details

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

View Details

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	`NCT04257019` - Pain, Anxiety During Interventional Spine Procedures	N/A
Completed	`NCT05656677` - Parental Involvement in Pain Reducing Measures	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	`NCT05070325` - Nonpharmacological Methods for Children	N/A
Completed	`NCT05179291` - Efficacy of VR and Buzzy on Pain and Anxiety	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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Effect of Preprocedural Subanesthetic Ketamine on Pain and Anxiety

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms