The purpose of this study is to compare two commonly used circumcision clamps (Gomco and Mogen) to see which results in less neonatal pain.
Objective: To compare pain levels assessed by salivary cortisol and standardized neonatal pain scale among the two most common infant circumcision techniques in uncomplicated pregnancies after a thorough resident-wide education curriculum under attending physician supervision. The secondary objectives are to assess the operative time, complication rates such as infection and bleeding and short term outcomes including need for re-circumcision among treatment groups. Hypothesis: The Mogen technique of circumcision is less painful, faster, and associated with less bleeding for newborns when compared to the Gomco technique after a resident circumcision standard teaching curriculum.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
274
Neonatal male circumcision utilizing the Gomco Circumcision Clamp
Neonatal male circumcision utilizing the Mogen Circumcision Clamp
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, United States
Neonatal Salivary Cortisol Level
Neonatal pain will be assessed by change in salivary cortisol, measured in mcg/dL., level pre and post procedure
Time frame: Approximately 2 hours before and 15 minutes after the procedure
Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool
The CRIES score assigns points for crying characteristics, oxygen requirements, change in vital signs, facial expressions, and the infant's sleep state. The minimum and maximum scores of CRIES is 0 to 10, respectively with the lower score associated with lower pain and the higher score associated with high amount of pain.
Time frame: CRIES assessment completed prior to the procedure and post procedure.
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