Suspended

Acetaminophen and Post Circumcision Pain Control

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Acetaminophen

Drug
Who is being recruted

Neurologic Manifestations+1

+ Pain

+ Signs and Symptoms

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: September 2015
See protocol details

Summary

Principal SponsorColumbia University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2015

Actual date on which the first participant was enrolled.

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.

Official TitleAcetaminophen and Post Circumcision Pain Control
NCT02498483
Principal SponsorColumbia University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and Symptoms

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Well Baby Nursery at New York Prebyterian-Columbia

New York, United StatesOpen Well Baby Nursery at New York Prebyterian-Columbia in Google Maps
SuspendedOne Study Center