Clinical Trials Logo

Clinical Trial Summary

The assessment and treatment of pain in neonates remains a challenge. In an effort to improve the quality of care while limiting opioid-related adverse effects, this study aims to determine the efficacy of a non-pharmacological intervention on the mitigation of nociception-specific responses to a skin breaking procedure in term and preterm neonates. Such responses will be measured using behavioral measures as well as with electroencephalography-based methods.


Clinical Trial Description

Eligible neonates who are 36-56 weeks post-menstrual age and who are scheduled to undergo a clinically required heel lance will be studied after obtaining appropriate verbal and written consent from the respective parents. Subjects will be monitored during a baseline resting state, during vibratory stimuli alone, and during a heel lance that is randomized to be preceded or not preceded by the vibratory stimulus. The sessions will include time-locked video recordings and electroencephalography using a specialized net of 128 electrodes (Electrical Geodesics Inc., EGI; Eugene, OR). Behavioral and cortical responses will be then be analyzed in a blinded fashion to determine the efficacy of the vibratory intervention, as well as to validate what behavioral responses are most correlated with nociception-specific cortical activity. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04050384
Study type Interventional
Source Nationwide Children's Hospital
Contact
Status Completed
Phase N/A
Start date November 13, 2018
Completion date January 23, 2020

See also
  Status Clinical Trial Phase
Completed NCT03334929 - Virtual Reality Distraction for Anxiety Reduction During Trigger Points Procedures in Pain Medicine Clinic N/A
Recruiting NCT06129383 - The Effect of Adding PIFP Block to SAP Block on Postoparative Pain Management in Patient Planned for Breast Surgery N/A
Completed NCT06054945 - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Active, not recruiting NCT02276495 - Can Single-Injection Adductor Canal Blocks Improve PostOp Pain Relief in Patients Undergoing Total Knee Arthroplasty? N/A
Completed NCT04094246 - Battlefield Acupuncture Following Shoulder Surgery N/A
Completed NCT05514236 - Effect of Virtual Reality and Music Therapy on Pain Relief in Outpatient Hysteroscopy N/A
Recruiting NCT04809935 - EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy Phase 4
Not yet recruiting NCT05492903 - COMmunity of Practice And Safety Support for Navigating Pain (COMPASS-NP) N/A
Not yet recruiting NCT04328805 - Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome. Phase 4
Completed NCT02922101 - Evaluation of the Effectiveness of an Audit and Feedback Intervention With Quality Improvement Toolbox in Intensive Care N/A
Completed NCT01541293 - Intrauterine Lidocaine for Laminaria Phase 1
Not yet recruiting NCT01059487 - Bringing Acute and Wellness Care to Underserved Populations Using Traditional Chinese Medicine Phase 0
Completed NCT03290378 - Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy Phase 3
Recruiting NCT05794828 - Erector Spinae Regional Anesthesia for Pain Control Early Phase 1
Active, not recruiting NCT04109885 - Paracervical Injection for Headache in the Emergency Department Phase 2
Recruiting NCT05857202 - Oxidative Stress and Inflammation Biomarkers in Surgically Treated Patients With Laryngeal Cancer
Recruiting NCT03851042 - Virtual Reality for Postoperative Pain After Laparoscopic Hysterectomy N/A
Completed NCT04566536 - NoL Monitor Performances of Nociceptive and Non-nociceptive Stimuli Discrimination During Robotic Surgery
Completed NCT03471390 - Improving Pain Management in Nursing Homes: a Pilot Study N/A
Enrolling by invitation NCT02995278 - Usage and Plan of Care Changes Due to Drug Screenings