drugset / Trial / NCT02498483

Acetaminophen and Post Circumcision Pain Control

NCT02498483 ↗

Phase 4 Terminated 11 enrolled Columbia University
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2015-09
Primary completion
2017-01
Completion
2018-06

Outcome

Outcome not reported

Stopped: “Understaffing”

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 15 mg/kg Oral

Indications

No indication recorded.