Circumcision, Male
Conditions
Keywords
neonatal circumcision, neonatal surgical pain, Mogen, Gomco
Brief summary
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
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.
Interventions
DEVICEGomco Circumcision Clamp
Neonatal male circumcision utilizing the Gomco Circumcision Clamp
DEVICEMogen Circumcision Clamp
Neonatal male circumcision utilizing the Mogen Circumcision Clamp
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
No minimum to 4 Days
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Salivary Cortisol Level | 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 |
| Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool | 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. |
Countries
United States
Participant flow
Recruitment details
274 infants were enrolled into the study from 10/2012 through 6/2013.
Participants by arm
| Arm | Count |
|---|---|
| Gomco Circumcision Clamp Gomco circumcision clamp used for neonatal circumcision.
Gomco Circumcision Clamp | 137 |
| Mogen Circumcision Clamp Mogen circumcision clamp used for neonatal circumcision.
Mogen Circumcision Clamp | 137 |
| Total | 274 |
Baseline characteristics
| Characteristic | Gomco Circumcision Clamp | Mogen Circumcision Clamp | Total |
|---|---|---|---|
| Age, Customized Gestational Age | 39.44 Weeks STANDARD_DEVIATION 1.08 | 39.29 Weeks STANDARD_DEVIATION 1.14 | 39.36 Weeks STANDARD_DEVIATION 1.11 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 137 Participants | 137 Participants | 274 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 99 | 2 / 117 |
| serious Total, serious adverse events | 0 / 99 | 0 / 117 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gomco Circumcision Clamp | Neonatal Salivary Cortisol Level | Pre-op Salivary Cortisol Level | 0.63 mcg/dL | Standard Deviation 0.59 |
| Gomco Circumcision Clamp | Neonatal Salivary Cortisol Level | Post-op Salivary Cortisol Level | 1.14 mcg/dL | Standard Deviation 0.8 |
| Mogen Circumcision Clamp | Neonatal Salivary Cortisol Level | Pre-op Salivary Cortisol Level | 0.72 mcg/dL | Standard Deviation 0.66 |
| Mogen Circumcision Clamp | Neonatal Salivary Cortisol Level | Post-op Salivary Cortisol Level | 1.08 mcg/dL | Standard Deviation 0.68 |
Primary
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gomco Circumcision Clamp | Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool | 2 units on a scale |
| Mogen Circumcision Clamp | Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool | 2 units on a scale |
p-value: 0.457Wilcoxon (Mann-Whitney)