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

TriHealth Inc.274 enrolled

Overview

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

Conditions

Circumcision, Male

Interventions

Gomco Circumcision ClampDEVICE

Neonatal male circumcision utilizing the Gomco Circumcision Clamp

Mogen Circumcision ClampDEVICE

Neonatal male circumcision utilizing the Mogen Circumcision Clamp

Eligibility

Sex: MALEMax age: 4 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

TriHealth Good Samaritan Hospital

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.