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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen Arm | Experimental | Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. |
|
| Non-treatment Arm | No Intervention | Routine circumcision without acetaminophen. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Infants will receive 15 mg/kg of acetaminophen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Baseline and 4 hours | |
| Change in Salivary Cortisol Rise | Baseline and 4 hours | |
| Respiratory Rate |
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Inclusion Criteria:
Healthy newborns between 36-42 weeks gestational age Admitted to the well baby nursery who's parents are requesting circumcision. Eligibility includes
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roya O'Neal, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Well Baby Nursery at New York Prebyterian-Columbia | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | Includes subjects who received acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. |
| FG001 | Control Arm | Includes subjects who received routine care post circumcision. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | Includes subjects who received acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. |
| BG001 | Control Arm | Includes subjects who received routine care post circumcision. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | score on a scale | Baseline and 4 hours |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetaminophen Arm | Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Woo Baidal | Columbia University | 212-342-2962 | jw3286@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Baseline and 4 hours |
| Pulse Oximetry | Baseline 4 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Non-treatment Arm | Routine circumcision without acetaminophen. |
|
|
| Secondary | Heart Rate | Posted | Mean | Full Range | Beats per minute | Baseline and 4 hours |
|
|
|
| Secondary | Change in Salivary Cortisol Rise | 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. | Posted | Mean | Full Range | nmol/L | Baseline and 4 hours |
|
|
|
| Secondary | Respiratory Rate | Posted | Mean | Full Range | breaths per minute | Baseline and 4 hours |
|
|
|
| Secondary | Pulse Oximetry | Posted | Mean | Full Range | percentage of oxygen saturation | Baseline 4 hours |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Non-treatment Arm | Routine circumcision without acetaminophen. | 0 | 5 | 0 | 5 | 0 | 5 |
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| Aniline Compounds |
| D000588 | Amines |