Acetaminophen and Post Circumcision Pain Control

• Sponsor: Columbia University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02498483
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arms: 2
• Duration (Months): 33
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Sep 1, 2015
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Neonatal Infant Pain Scale (NIPS) [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 [Baseline and 4 hours]

2. Change in Salivary Cortisol Rise [Baseline and 4 hours]

3. Respiratory Rate [Baseline and 4 hours]

4. Pulse Oximetry [Baseline 4 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Hours to 36 Hours
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Well Baby Nursery at New York Prebyterian-Columbia	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University

Investigators

• Principal Investigator: Roya O'Neal, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Columbia University
• ClinicalTrials.gov Identifier: NCT02498483
• Other Study ID Numbers: AAAN7406
• First Posted: Jul 15, 2015
• Last Update Posted: Jun 18, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Columbia University: Infant pain; Acetaminophen; Circumcision
• Additional relevant MeSH terms: Acetaminophen

Study Results

Participant Flow

Arm/Group Title	Treatment Arm	Control Arm
Arm/Group Description	Includes subjects who received acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.	Includes subjects who received routine care post circumcision.
Period Title: Overall Study
STARTED	6	5
COMPLETED	6	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Treatment Arm	Control Arm	Total
Arm/Group Description	Includes subjects who received acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.	Includes subjects who received routine care post circumcision.	Total of all reporting groups
Overall Participants	6	5	11
Age (Count of Participants)
<=18 years	6 100%	5 100%	11 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	6 100%	5 100%	11 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 66.7%	3 60%	7 63.6%
Not Hispanic or Latino	2 33.3%	2 40%	4 36.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 33.3%	0 0%	2 18.2%
White	0 0%	2 40%	2 18.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	4 66.7%	3 60%	7 63.6%

Outcome Measures

1. Primary Outcome

Title	Neonatal Infant Pain Scale (NIPS)
Description	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.
Time Frame	Baseline and 4 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetaminophen Arm	Non-treatment Arm
Arm/Group Description	Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. Acetaminophen: Infants will receive 15 mg/kg of acetaminophen.	Routine circumcision without acetaminophen.
Measure Participants	6	5
Baseline	2.5	3.2
4 Hours post-circumcision	1.0	1.4

2. Secondary Outcome

Title	Heart Rate
Time Frame	Baseline and 4 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetaminophen Arm	Non-treatment Arm
Arm/Group Description	Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. Acetaminophen: Infants will receive 15 mg/kg of acetaminophen.	Routine circumcision without acetaminophen.
Measure Participants	6	5
Baseline	138.7	128.8
4 Hours post-circumcision	125	124.8

3. Secondary Outcome

Title	Change in Salivary Cortisol Rise
Time Frame	Baseline and 4 hours

Outcome Measure Data

Analysis Population Description

Only subjects who were able to provide saliva were incorporated into the data analysis. One subject in the acetaminophen arm could not provide a saliva sample for analysis, and 2 subjects in the control arm could not provide saliva samples for analysis.

Arm/Group Title	Acetaminophen Arm	Non-treatment Arm
Arm/Group Description	Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. Acetaminophen: Infants will receive 15 mg/kg of acetaminophen.	Routine circumcision without acetaminophen.
Measure Participants	5	3
Baseline	0.389	0.427
30 minutes post-circumcision	1.085	0.811

4. Secondary Outcome

Title	Respiratory Rate
Time Frame	Baseline and 4 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetaminophen Arm	Non-treatment Arm
Arm/Group Description	Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. Acetaminophen: Infants will receive 15 mg/kg of acetaminophen.	Routine circumcision without acetaminophen.
Measure Participants	6	5
Baseline	59.7	45
4 Hours post-circumcision	42	43.6

5. Secondary Outcome

Title	Pulse Oximetry
Time Frame	Baseline 4 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acetaminophen Arm	Non-treatment Arm
Arm/Group Description	Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. Acetaminophen: Infants will receive 15 mg/kg of acetaminophen.	Routine circumcision without acetaminophen.
Measure Participants	6	5
Baseline	98.8	98.2
4 Hours post-circumcision	97.5	98.4

Adverse Events

Adverse Event Reporting Description	The AE data is reported for the combination of all arms/groups because the data was collected and observed for the entire study population and not per arm.
Arm/Group Title	Acetaminophen Arm		Non-treatment Arm
Arm/Group Description	Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.		Routine circumcision without acetaminophen.
All Cause Mortality
	Acetaminophen Arm		Non-treatment Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/5 (0%)
Serious Adverse Events
	Acetaminophen Arm		Non-treatment Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Acetaminophen Arm		Non-treatment Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.