TriHealth Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
NCT Number: NCT01726036
The purpose of this study is to compare two commonly used circumcision clamps (Gomco and Mogen) to see which results in less neonatal pain.
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Male
Interventional
Not applicable
Cincinnati, Ohio, 45220, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Neonatal male circumcision utilizing the Gomco Circumcision Clamp
Neonatal male circumcision utilizing the Mogen Circumcision Clamp
Time frame: Approximately 2 hours before and 15 minutes after the procedure
Neonatal pain will be assessed by change in salivary cortisol, measured in mcg/dL., level pre and post procedure
Time frame: CRIES assessment completed prior to the procedure and post procedure.
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.
TriHealth Inc.
Other
Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial: The GMRT Study.
Acronym: GMRT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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