Clinical trial NCT02498483: Acetaminophen and Post Circumcision Pain Control
Official title: Acetaminophen and Post Circumcision Pain Control
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Circumcision
Keywords: Infant pain
Acetaminophen
Circumcision
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 11
Sex: MALE
Minimum age (years): 10
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Male circumcision is a common surgical procedure performed in the newborn period. The American Academy of Pediatrics Task Force on Circumcision recently published an update on circumcision policy stating the benefits of male circumcision outweigh the risks. Given this update, the investigators anticipate a percentage of families who were previously undecided about circumcision will choose to have their newborn circumcised. A common concern for both parents and physicians is effective pain control. For intra-operative pain control, dorsal penile nerve block (DPNB) has been found to be the most effective when compared to EMLA (lidocaine-prilocaine) or placebo. Acetaminophen is a relatively safe, easy to administer analgesic. Prior studies have suggested that acetaminophen could be helpful in postoperative comfort. However, studies examining the effectiveness of acetaminophen for postoperative pain control in infants who received DPNB are lacking. In addition, prior studies have been incomplete in the assessment of neonatal pain.

Eligibility 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.

Primary outcomes:
measure: Neonatal Infant Pain Scale (NIPS)
timeFrame: Baseline and 4 hours
Secondary outcomes:
measure: Heart Rate
timeFrame: Baseline and 4 hours
measure: Change in Salivary Cortisol Rise
timeFrame: Baseline and 4 hours
measure: Respiratory Rate
timeFrame: Baseline and 4 hours
measure: Pulse Oximetry
timeFrame: Baseline 4 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Well Baby Nursery at New York Prebyterian-Columbia
state: New York
Study officials:
affiliation: Columbia University
name: Roya O'Neal, MD
role: PRINCIPAL_INVESTIGATOR
References: