NCT02498483

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 11, 2019

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

June 30, 2015

Results QC Date

March 26, 2019

Last Update Submit

June 10, 2019

Conditions

PainCircumcision

Keywords

Infant painAcetaminophenCircumcision

Outcome Measures

Primary Outcomes (1)

  • Neonatal Infant Pain Scale (NIPS)

    The Neonatal Infant Pain Scale (NIPS) is a behavioral scale and can be utilized with both full-term and pre-term infants. The tool uses the behaviors that nurses have described as being indicative of infant pain or distress. It is composed of six (6) indicators: facial expression, cry, breathing patterns, arms, legs and state of arousal. Each behavioral indicator is scored with 0 or 1 except "cry", which has three possible descriptors therefore, being scored with a 0, 1 or 2. Infants are observed for one minute in order to fully assess each indicator. Total pain scores range from 0-7, with a score of 0-2 indicating mild to no pain and no suggested intervention (better outcome) to a score \>4 indicating severe pain, suggesting non-pharmacological and/or pharmacological interventions may be needed.

    Baseline and 4 hours

Secondary Outcomes (4)

  • Heart Rate

    Baseline and 4 hours

  • Change in Salivary Cortisol Rise

    Baseline and 4 hours

  • Respiratory Rate

    Baseline and 4 hours

  • Pulse Oximetry

    Baseline 4 hours

Study Arms (2)

Acetaminophen Arm

EXPERIMENTAL

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

Drug: Acetaminophen

Non-treatment Arm

NO INTERVENTION

Routine circumcision without acetaminophen.

Interventions

AcetaminophenDRUG

Infants will receive 15 mg/kg of acetaminophen.

Acetaminophen Arm

Eligibility Criteria

Age10 Hours - 36 Hours
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy newborns between 36-42 weeks gestational age Admitted to the well baby nursery who's parents are requesting circumcision. Eligibility includes
  • Apgar score at 5 minutes \>7
  • birthweight greater than 2.4 kg
  • Age of at least 10 hours
  • At least one void.

You may not qualify if:

  • Newborns of substance abusing mothers.
  • Newborns with any contraindications to routine circumcision, anatomical or hematologic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Well Baby Nursery at New York Prebyterian-Columbia

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Jennifer Woo Baidal
Organization
Columbia University
jw3286@cumc.columbia.edu
212-342-2962

Study Officials

  • Roya O'Neal, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 15, 2015

Study Start

September 1, 2015

Primary Completion

January 1, 2017

Study Completion

June 1, 2018

Last Updated

June 18, 2019

Results First Posted

June 11, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)