Status:
COMPLETED
Effect of a Vibratory Stimulus on Mitigating Nociception-specific Responses to Skin Puncture in Neonates
Lead Sponsor:
Lance M Relland, MD, PhD
Conditions:
Infant, Newborn
Infant, Premature
Eligibility:
All Genders
36-56 years
Phase:
NA
Brief 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 effica...
Detailed 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 t...
Eligibility Criteria
Inclusion
- Neonatal Intensive Care Unit patient
- Between 36 to 56 weeks post-menstrual age
- Medically stable
- Due to have a clinically required bedside heel stick as part of their routine care
Exclusion
- Congenital anomalies or abnormalities affecting the brain
- Patient is over 4 months corrected age
- Infants who receive analgesics or sedatives within 72 hours prior to assessment
- Administration of maternal analgesics or sedatives to which the infant may be exposed
Key Trial Info
Start Date :
November 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2020
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT04050384
Start Date
November 13 2018
End Date
January 23 2020
Last Update
November 29 2023
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205