New York, New York 10032


Purpose:

Infants do not routinely receive acetaminophen for pain control after circumcision. This study will determine if acetaminophen is effective at controlling infant pain after circumcision using nerve block and oral dextrose. Infants will undergo the routine circumcision procedure , and half will be randomly selected to receive half acetaminophen immediately at the end of the procedure. Afterwards, infant's vitals signs (heart rate, respiratory rate, oxygen saturation), NIPS (the neonatal infant pain scale), and salivary cortisol levels will be checked in regular intervals up to 4 hours. The NIPS is a validated pain scoring system based on the appearance of the infant. A reduction in NIPS for those infants who receive acetaminophen versus nothing will be our primary outcome to determine if our study is significant.


Study summary:

All subjects and controls will be nil per os (NPO) ONLY 30 minutes post procedure, not before the procedure. Due to the cortisol collection requirements, infants will remain NPO 30 minutes post the procedure to ensure accurate levels, per manufacturer protocol. All infants will undergo a standardized circumcision using a modified dorsal penile nerve block (DPNB), dextrose+pacifier and a Gomco clamp. Before being removed from the circumstraint, half the infants will receive 15 mg/kg of acetaminophen via a syringe. Neonates will be monitored at time -15, time 0, 30, 60, 90, 120 and 240 minutes for heart rate (HR), respiratory rate (RR), and pulse oximetry (Sa02), for pain using standard NIPS, and at -15 and 30 minutes for salivary cortisol level. Time -15 minutes will be defined as just prior to placement in restraint, assuming about a 15 interval to the full completion of the procedure and time 0 as the point just prior to removal from restraint and administration of acetaminophen. The NIPS and vital signs will be determined by Dr. Kimon Violaris, a neonatologist trained in obtaining NIPS and the entire procedure will be recorded. In addition to usual vital sign assessments, infants will be monitored for pain using NIPS- neonatal infant pain score, a validated infant pain scoring system based on 6 behavioral criteria: 1. facial expression 0 (relaxed), 1 (grimace) 2. cry 0 (none) , 1 (whimper) , 2 (vigorous) 3. arms 0 (relaxed/restrained) ,1 (flexed/extended) 4. legs 0 relaxed/restrained),1 (flexed/extended) 5. state of arousal 0 (sleeping),1 (awake). B. Salivary cortisol levels will be collected using a salivary swab kit provided by the manufacturer, Salimetrics. C. Vital signs of HR, RR, pulse ox will be measured.


Criteria:

Inclusion Criteria: Healthy newborns between 36-42 weeks gestational age Admitted to the well baby nursery who's parents are requesting circumcision. Eligibility includes 1. Apgar score at 5 minutes >7 2. birthweight greater than 2.4 kg 3. Age of at least 10 hours 4. At least one void. Exclusion Criteria: 1. Newborns of substance abusing mothers. 2. Newborns with any contraindications to routine circumcision, anatomical or hematologic.


NCT ID:

NCT02498483


Primary Contact:

Principal Investigator
Roya O'Neal, MD
Columbia University

Roya O'Neal, MD
Phone: 212-305-7623
Email: rs3176@columbia.edu


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States

Roya Oneal, MD
Phone: 212-305-7623

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.