Acetaminophen and Post Circumcision Pain Control

Stopped early · Phase 4

Conditions studied: Pain, Circumcision

In brief

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.

Key facts

Study ID

NCT02498483

Run by

Columbia University

People needed

11

Starts

2015-09-01

Expected to finish

2018-06-01

Last updated by the study team

2019-06-18

Who can join

Age: 0 and older, up to 0. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy newborns between 36-42 weeks gestational age Admitted to the well baby nursery who's parents are requesting circumcision. Eligibility includes
• Apgar score at 5 minutes >7
• birthweight greater than 2.4 kg
• Age of at least 10 hours
• At least one void.

You may not qualify if…

• Newborns of substance abusing mothers.
• Newborns with any contraindications to routine circumcision, anatomical or hematologic.

Where it is running

• Well Baby Nursery at New York Prebyterian-Columbia — New York, New York, United States

Full record on ClinicalTrials.gov

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