Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial

Study Overview
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Brief Summary
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The purpose of this study is to compare two commonly used circumcision clamps (Gomco and Mogen) to see which results in less neonatal pain.

Detailed Description
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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.

Official Title
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Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial: The GMRT Study.

Conditions
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Circumcision, Male

Intervention / Treatment
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* Device: Gomco Circumcision Clamp
* Device: Mogen Circumcision Clamp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: term infants delivered by cesarean section or vaginal delivery at Good Samaritan Hospital during the time period of the study Infants with no blood drawn two hours prior to the circumcision Singletons Exclusion Criteria: Infants with congenital anomalies and/or known chromosomal syndromes Preterm infants defined as less than 37 / 0 weeks gestation. Delivery secondary to non-reassuring fetal heart tracing, defined by the delivering physician Infants of diabetic mothers. Infants of preeclamptic mothers on magnesium sulfate within 48 hours of delivery. Infants delivered by vacuum-assisted or forceps-assisted vaginal delivery. Infants of mothers who took steroids for fetal lung maturity within 7 days of delivery. (This may apply to term infants if the mother had no prenatal care and her gestational age was not known on arrival). Infants with a 5 minutes apgar score of less than 7 Infants born to mothers with a history of drug abuse during pregnancy, currently on methadone, or with Hepatitis C or HIV.

Ages Eligible for Study
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Maximum Age: 4 Days

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gomco Circumcision Clamp<br>Gomco circumcision clamp used for neonatal circumcision. | Device: Gomco Circumcision Clamp<br>* Neonatal male circumcision utilizing the Gomco Circumcision Clamp<br>|
| Active Comparator: Mogen Circumcision Clamp<br>Mogen circumcision clamp used for neonatal circumcision. | Device: Mogen Circumcision Clamp<br>* Neonatal male circumcision utilizing the Mogen Circumcision Clamp<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Salivary Cortisol Level | Neonatal pain will be assessed by change in salivary cortisol, measured in mcg/dL., level pre and post procedure | 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. | CRIES assessment completed prior to the procedure and post procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatal circumcision, neonatal surgical pain, Mogen, Gomco