Acetaminophen and Post Circumcision Pain Control

NCT ID: NCT02498483

Last Updated: 2019-06-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-06-30

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.

Conditions

Pain; Circumcision

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acetaminophen Arm

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

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

Infants will receive 15 mg/kg of acetaminophen.

Non-treatment Arm

Routine circumcision without acetaminophen.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acetaminophen

Infants will receive 15 mg/kg of acetaminophen.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 10 Hours
• Maximum Eligible Age: 36 Hours
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roya O'Neal, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Well Baby Nursery at New York Prebyterian-Columbia

New York, New York, United States

Countries

United States

Other Identifiers

AAAN7406

Identifier Type: -

Identifier Source: org_study_id