Acetaminophen and Post Circumcision Pain Control
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|ClinicalTrials.gov Identifier: NCT02498483|
Recruitment Status : Terminated (Understaffing)
First Posted : July 15, 2015
Results First Posted : June 11, 2019
Last Update Posted : June 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain Circumcision||Drug: Acetaminophen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|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|
Experimental: Acetaminophen Arm
Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.
Infants will receive 15 mg/kg of acetaminophen.
No Intervention: Non-treatment Arm
Routine circumcision without acetaminophen.
- 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.
- Heart Rate [ Time Frame: Baseline and 4 hours ]
- Change in Salivary Cortisol Rise [ Time Frame: Baseline and 4 hours ]
- Respiratory Rate [ Time Frame: Baseline and 4 hours ]
- Pulse Oximetry [ Time Frame: Baseline 4 hours ]
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 ClinicalTrials.gov identifier (NCT number): NCT02498483
|United States, New York|
|Well Baby Nursery at New York Prebyterian-Columbia|
|New York, New York, United States, 10032|
|Principal Investigator:||Roya O'Neal, MD||Columbia University|