Acetaminophen and Post Circumcision Pain Control

Columbia University

Status and phase: Terminated; Phase 4

Conditions: Circumcision; Pain

Treatments: Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT02498483

AAAN7406

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: Male

Ages: 10 to 36 hours old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

11 participants in 2 patient groups

Acetaminophen Arm

Experimental group

Description:

Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.

Treatment:

Drug: Acetaminophen

Non-treatment Arm

No Intervention group

Description:

Routine circumcision without acetaminophen.