Acetaminophen and Post Circumcision Pain Control

Pain Clinical Trial

Official title:

Acetaminophen and Post Circumcision Pain Control

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02498483
• Other study ID #: AAAN7406
• Status: Terminated
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: June 2018

Study information

• Verified date: June 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A to 36 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Circumcision
• Pain

Intervention

Drug:
• Acetaminophen
Infants will receive 15 mg/kg of acetaminophen.

Locations

Country	Name	City	State
United States	Well Baby Nursery at New York Prebyterian-Columbia	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart Rate		Baseline and 4 hours
Secondary	Change in Salivary Cortisol Rise		Baseline and 4 hours
Secondary	Respiratory Rate		Baseline and 4 hours
Secondary	Pulse Oximetry		Baseline 4 hours