Acetaminophen and Post Circumcision Pain Control

• Status: Terminated
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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), the neonatal infant pain scale (NIPS), 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 the primary outcome to determine if the study is significant.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Columbia University
• Treatments: Acetaminophen

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.