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Acetaminophen and Post Circumcision Pain Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02498483
Recruitment Status : Terminated (Understaffing)
First Posted : July 15, 2015
Results First Posted : June 11, 2019
Last Update Posted : June 18, 2019
Information provided by (Responsible Party):
Columbia University

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.

Condition or disease Intervention/treatment Phase
Pain Circumcision Drug: Acetaminophen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acetaminophen and Post Circumcision Pain Control
Study Start Date : September 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Acetaminophen Arm
Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.
Drug: Acetaminophen
Infants will receive 15 mg/kg of acetaminophen.

No Intervention: Non-treatment Arm
Routine circumcision without acetaminophen.

Primary Outcome Measures :
  1. Neonatal Infant Pain Scale (NIPS) [ Time Frame: Baseline and 4 hours ]
    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.

Secondary Outcome Measures :
  1. Heart Rate [ Time Frame: Baseline and 4 hours ]
  2. Change in Salivary Cortisol Rise [ Time Frame: Baseline and 4 hours ]
  3. Respiratory Rate [ Time Frame: Baseline and 4 hours ]
  4. Pulse Oximetry [ Time Frame: Baseline 4 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 36 Hours   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02498483

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United States, New York
Well Baby Nursery at New York Prebyterian-Columbia
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
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Principal Investigator: Roya O'Neal, MD Columbia University

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Responsible Party: Columbia University Identifier: NCT02498483    
Other Study ID Numbers: AAAN7406
First Posted: July 15, 2015    Key Record Dates
Results First Posted: June 11, 2019
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Columbia University:
Infant pain
Additional relevant MeSH terms:
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Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs